TEL AVIV, Israel, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that it will host an R&D Day on Wednesday, November 11, 2026. At the R&D Day, Teva’s leadership will discuss its R&D pipeline, its near-term value-creation potential over the next five years, and Teva’s ongoing transformation into an innovative biopharma company through the Pivot to Growth strategy.
The event will take place in New York, N.Y. Presentations will begin at 8:30 a.m. Eastern Time and are expected to conclude at 12:30 p.m. Eastern Time.
Due to limited capacity, in-person attendance is by invitation only. Analysts and institutional investors invited to attend will receive separate registration instructions.
For questions regarding the event, please contact Teva's Investor Relations team at [email protected].
A live webcast of the event and presentation materials will be available on Teva's Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations.
An archived version of the webcast will be available within 24 hours after the end of the live event.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
This document and the presentation at the conferences may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Key Takeaways Teva's Weltruza gets FDA nod as the first once-monthly subcutaneous olanzapine LAI for schizophrenia in adultsWeltruza offers three dosage strengths without loading doses, oral supplementation or post-injection check.Weltruza's weight gain and metabolic changes align with oral olanzapine's known safety profile.
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the FDA has approved Weltruza (olanzapine) extended-release injectable suspension for the treatment of schizophrenia in adults.
Following the nod, Weltruza became the first and only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine approved for adults with schizophrenia.
Shares of Teva were up 4.7% following the announcement on Oct. 9.
Weltruza will be launched in the United States in the coming weeks. The product will be available in three dosage strengths — 318 mg, 425 mg and 531 mg — corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively. Per management, the treatment requires no loading doses, oral supplementation or post-injection monitoring.
Weltruza offers an alternative to daily oral olanzapine, a widely prescribed atypical antipsychotic for schizophrenia. Weltruza is designed to help address treatment adherence challenges associated with daily medications by providing a once-monthly injection.
TEVA Price PerformanceYear to date, shares of Teva have rallied 31.7% compared with the industry’s 9.2% rise.
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More on TEVA’s Weltruza FDA NodThe latest FDA approval for Weltruza was based on results from the pivotal phase III SOLARIS study, which demonstrated improvements in schizophrenia symptoms, significant reduction in illness severity, and improvement in personal and social functioning.
The three Weltruza doses showed similar tolerability profiles. The most common adverse events included weight gain, somnolence, headache, constipation and injection-site reactions. Weight gain and metabolic changes were consistent with the known safety profile of oral olanzapine.
In December 2025, Teva submitted the new drug application (NDA) to the FDA seeking approval for Weltruza for treating adults with schizophrenia.
Teva’s marketing authorization application, seeking approval for olanzapine long-acting injectable (TEV-‘749) for treating adults with schizophrenia, is currently under review in Europe.
TEVA Seeks Expansion of Schizophrenia PortfolioTEVA currently markets Uzedy extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, which was approved for the treatment of schizophrenia in the United States in 2023.
Uzedy is one of the key new branded drugs for Teva, contributing meaningfully to its revenues.
In the first six months of 2026, Uzedy’s sales surged 51% year over year to $140 million, mainly driven by volume growth. TEVA anticipates Uzedy sales to be in the range of $270-$290 million in 2026.
Management believes Uzedy has substantial long-term potential because long-acting injectable antipsychotics are increasingly being adopted in psychiatric care.
Also, the FDA nod to Weltruza should help Teva diversify and address a broader schizophrenia patient population.
Meanwhile, Teva has also made decent progress with its branded pipeline, which includes duvakitug, its anti-TL1A therapy for inflammatory bowel diseases, ulcerative colitis and Crohn’s disease (CD).
Teva has partnered with Sanofi (SNY - Free Report) for duvakitug to maximize the value of the asset. Teva and Sanofi will equally share the development costs globally.
Teva plans to begin other studies for duvakitug in two additional indications — hidradenitis suppurativa and fibrostenotic CD. The company believes duvakitug has pipeline-in-a-product potential.
TEVA's Zacks Rank & Stocks to ConsiderTeva currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Actuate Therapeutics, Inc. (ACTU - Free Report) and CRISPR Therapeutics (CRSP - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Actuate Therapeutics’ 2026 loss per share have narrowed from 86 cents to 73 cents, while loss per share estimates for 2027 have declined from 78 cents to 59 cents during the same time. ACTU’s shares have plunged 90% year to date.
Actuate Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 8.21%.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have narrowed from $4.53 to $4.47, while loss per share estimates for 2027 have declined from $3.63 to $3.61 during the same time. CRSP’s shares have risen 1.9% year to date.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average negative surprise being 1.38%.
The U.S. Food and Drug Administration (FDA) recently approved Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to market Weltruza, a once-monthly subcutaneous injectable for adult patients with schizophrenia.
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“Weltruza offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape,” said Chris Fox, executive vice president, U.S. Commercial and Head of Innovative Franchise at Teva.
“This important milestone also helps further Teva’s Pivot to Growth strategy,” Fox further commented.
While doctors widely prescribe oral olanzapine to treat schizophrenia, daily pills often cause adherence issues that increase patient instability and relapse risks. Weltruza solves this problem by delivering a steady dose of the medication.
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The drug utilizes SteadyTeq, a proprietary copolymer technology developed by Medincell, to ensure sustained release.
Clinical Success and AvailabilityIn the Phase 3 SOLARIS trial, patients taking Weltruza experienced significant reductions in illness severity and notable improvements in both symptoms and social functioning. Participants tolerated all three available doses well.
The company will launch the medication in the U.S. in the coming weeks to help treat the estimated 2.1 million Americans diagnosed with the condition. It will come in 318 mg, 425 mg, and 531 mg strengths, which match standard daily oral amounts.
Patients will not require loading doses, oral supplements, or post-injection monitoring.
European Expansion PlansLooking ahead, the European Medicines Agency accepted the marketing application for the long-acting injectable in May 2026, backed by the extensive SOLARIS clinical program.
TEVA Price Action: Teva Pharmaceutical shares were up 6.17% at $41.67 at the time of publication on Friday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
Photo: Shutterstock
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Teva Pharmaceutical Industries Limited (TEVA) Discusses FDA Approval of Weltruza and Strategic Growth Initiatives October 9, 2026 8:00 AM EDT
Company Participants
Christopher Stevo - Senior Vice President of Investor Relations & Competitive Intelligence
Richard Francis - President, CEO & Director
Eric Hughes - Executive VP of Global R&D and Chief Medical Officer
Christine Fox - Executive VP of US Commercial & Head of Innovative Franchise
Conference Call Participants
Joseph Thome - TD Cowen, Research Division
Michael DiFiore - Evercore ISI Institutional Equities, Research Division
Louise Chen - Scotiabank Global Banking and Markets, Research Division
Les Sulewski
David Amsellem - Piper Sandler & Co., Research Division
Jason Gerberry - BofA Securities, Research Division
Di Zhao - UBS Investment Bank, Research Division
Umer Raffat - Evercore ISI Institutional Equities, Research Division
Presentation
Operator
Hello, and welcome to the WELTRUZA approval conference call. My name is Alex. I'll be coordinating today's call. [Operator Instructions] I'll now hand it over to Chris Stevo, SVP, Investor Relations. Please go ahead.
Christopher Stevo
Senior Vice President of Investor Relations & Competitive Intelligence
Thank you, Alex. Good morning, and good afternoon, everyone. Thank you for joining us on short notice to discuss the U.S. FDA approval of WELTRUZA, olanzapine LAI. The materials are posted to the website this morning, and the press release is also on our website. And before I turn the call over to Richard Francis, I'd like to remind everyone that we'll be making forward-looking statements on the call.
The company cautions investors that any forward-looking statement involves risks and uncertainties and is not a guarantee of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. These factors are described in our earnings press release and our most recent Forms 10-K and 10-Q filed with the SEC. Any statements that we
MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA said the U.S. Food and Drug Administration has approved WELTRUZA, a once-monthly subcutaneous long-acting injectable formulation of olanzapine for schizophrenia.
Chief Executive Officer Richard Francis said the approval represents another step in Teva’s “Pivot to Growth” strategy, which began in 2023 and is intended to expand the company beyond its generics business into biopharmaceutical products. Francis said 2026 had already included several development milestones, including FDA priority review for ecopipam and clinical updates involving dupilumab and anti-IL-15 programs.
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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowWELTRUZA is designed to build on the established efficacy and safety profile of oral olanzapine while addressing medication adherence, according to Eric Hughes, Teva’s head of research and development and chief medical officer. The approved product is administered subcutaneously once a month and does not require a loading dose, oral supplementation or post-injection monitoring, the company said.
Focus on relapse prevention Hughes described schizophrenia as a debilitating illness for patients and families, saying that preventing relapses can help avoid hospitalizations and disease progression. Teva estimates that 2.2 million people in the U.S. have schizophrenia, with approximately 1.5 million receiving treatment. About 20% of treated patients use oral olanzapine, according to the company.
2 Generic Drug Stocks Ready to Surge in 2025Teva highlighted follow-on data from the SOLARIS study, in which the company said 4% of patients relapsed during a second study period extending to roughly one year. Hughes said the company believes a monthly injectable option may reduce adherence-related relapses for patients already benefiting from olanzapine.
“What WELTRUZA will bring, we hope, is that chance of decreasing relapses,” Hughes said. “By bringing an easily used subcutaneous injection that’s once a month, we’re chipping away at that adherence problem.”
Hughes also said WELTRUZA’s side-effect profile is identical to oral olanzapine’s profile, which he said gives physicians a familiar basis for selecting and monitoring patients. In response to questions about post-marketing obligations, Hughes said there are no unusual post-marketing commitments beyond pharmacovigilance monitoring and expedited reporting of suspected post-injection delirium/sedation syndrome, or PDSS, events.
Commercial launch plans and pricing Francis said WELTRUZA will carry a wholesale acquisition cost, or WAC, of $2,950. Chris Fox, Teva’s executive vice president of U.S. Commercial, said the company chose a flat price across doses to avoid discouraging physicians from using a dose that a patient may need.
Teva expects to use its existing commercial infrastructure for UZEDY, its long-acting risperidone product, to support the WELTRUZA launch. Fox said about 80% of the physicians currently targeted by the UZEDY sales force are also expected to be WELTRUZA targets.
The company views patients using oral olanzapine, particularly those with adherence challenges, as the initial opportunity for WELTRUZA. Teva said some patients could potentially switch from other long-acting injectable antipsychotics, but it expects most early use to come from oral olanzapine.
Fox said the company expects product, samples and hospital kits to be available in the coming weeks and does not need to wait for a permanent J-code to launch. Teva also plans a direct-to-consumer campaign intended to increase awareness among patients, caregivers and physicians.
Coverage expected to build over time Management said payer access, particularly among state Medicaid programs, will be an important determinant of the launch trajectory. Francis said some Medicaid coverage could begin immediately, while other states may take six to 18 months to add the product. Teva expects to have approximately 85% coverage by the end of the first year, he said.
The company also plans to pursue hospital formulary listings and Medicare coverage, while maintaining what it described as a balance between broad access and product value. Fox said Teva has established a patient-support hub to help patients navigate coverage and out-of-pocket costs, which will vary based on individual insurance status.
Francis said Teva does not expect significant WELTRUZA revenue during the first half of the following year, as payer coverage and hospital formulary access develop. He said meaningful revenue is expected in the second half, while early launch indicators will include samples, prescriptions, physician breadth and hospital adoption.
Teva has previously forecast combined annual revenue of $1.5 billion to $2 billion for UZEDY and WELTRUZA. Francis said the company intends to evaluate the pace of uptake and managed-care access before expanding on longer-term sales ambitions. Teva is also considering lifecycle-management opportunities for WELTRUZA, including a potential study in bipolar mania, Hughes said.
About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. Founded in 1901, the company develops, manufactures and distributes generic medicines, specialty pharmaceuticals, active pharmaceutical ingredients and biosimilars.
Teva's portfolio includes medicines for conditions affecting the central nervous system, respiratory system and other therapeutic areas. Its branded and specialty products include treatments such as Copaxone for multiple sclerosis, Austedo for movement disorders, Ajovy for migraine prevention and Uzedy for schizophrenia.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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The logo of Teva Pharmaceutical Industries is displayed at the company headquarters in Tel Aviv, Israel, February 20, 2024. REUTERS/Dylan Martinez Purchase Licensing Rights, opens new tab
CompaniesOct 9 (Reuters) - Teva (TEVA.TA), opens new tab said on Friday it had received approval from the US Food and Drug Administration for Weltruza, a once-monthly injection for adults with schizophrenia.
Weltruza is the second US-approved product from Israel-based Teva's partnership with French biotech company Medincell (MEDCL.PA), opens new tab after Uzedy, a long-acting injectable form of antipsychotic drug risperidone, which the FDA approved in 2023.
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Teva, which leads the development and commercialisation of Weltruza, said it expected to launch the drug in the US in the coming weeks
The product uses Medincell's long-acting injectable technology, which is designed to release medicines over extended periods
The long-acting formulation of antipsychotic medicine olanzapine may help address treatment-adherence challenges in schizophrenia and other chronic psychiatric illnesses
Medincell may be eligible for up to $112 million in additional development and commercial milestone payments under its agreement with Teva, along with royalties on sales
Shares of Teva were up 2% in Tel Aviv at 1124 GMT; Medincell shares were suspended upon the company's request ahead of the announcement
Adds context in paragraph 2, details on the medicine and companies' shares in bullet point summary
Reporting by Lucie Barbier in Gdansk, editing by Milla Nissi-Prussak
Our Standards: The Thomson Reuters Trust Principles., opens new tab
WELTRUZA™ (olanzapine) for extended-release injectable suspension is the first and only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults with no loading doses, no oral supplementation and no post-injection monitoring requiredThe approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement, significant reduction in illness severity and improvement in personal and social functioning, with a systemic safety profile consistent with oral olanzapine1As Teva drives forward its Pivot to Growth strategy, the company continues to deliver on its commitment to patient-centered innovation in neuroscience, including a differentiated long-acting injectable franchiseTeva will hold an investor call and live webcast on Friday, October 9, 2026, 8:00 a.m. ET
PARSIPPANY, N.J. and TEL AVIV, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA™ (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. WELTRUZA clinical trial results demonstrated improvement in symptoms (PANSS), significant reduction in illness severity (CGI-S), as well as improvement in personal and social functioning (PSP).1 In the coming weeks, WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required.1
A suite of downloadable multimedia assets is available here.
“WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape,” said Chris Fox, Executive Vice President, U.S. Commercial and Head of Innovative Franchise at Teva. “WELTRUZA was developed with the patient in mind from day one and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva’s Pivot to Growth strategy.”
Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment.2 However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse.1 WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.1
“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “WELTRUZA combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”
WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.1
“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “By offering a subcutaneous long-acting injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively.”
In the Phase 3 SOLARIS trial, all three doses of WELTRUZA were similarly tolerated, with the most common reported adverse events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions.1 Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain.1 Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5% and 4% of trial participants, respectively.1 Please refer to the Important Safety Information below for additional safety information.
An estimated 2.1 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and behaves.3 Schizophrenia is a complex medical condition that may require switching from oral options or between long-acting injectable options during the treatment journey.
WELTRUZA utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.
WELTRUZA will be available in the U.S. in the coming weeks.
The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia in adults in May 2026. The EMA submission is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. TEV-‘749 is not approved by the EMA at this time.
Teva Investor Call
Teva will hold an investor call and live webcast today, Friday, October 9, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET. To participate, please register in advance here. To access a live webcast of the presentation, visit Teva’s Investor Relations website. An archived version of the webcast will be available 24 hours after the end of the live discussion.
APPROVED USE
WELTRUZA™ (olanzapine) for extended-release injectable suspension is a prescription medicine used in adults for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about WELTRUZA?
WELTRUZA can cause serious side effects, including an increased risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). WELTRUZA is not for the treatment of people with dementia-related psychosis.
WELTRUZA may cause serious side effects, including:
Post-injection delirium/sedation syndrome (PDSS) is a serious problem that can happen when too much olanzapine enters the bloodstream too quickly. PDSS has happened in people who received another extended-release olanzapine medicine by injection into their muscles (intramuscularly). WELTRUZA is injected under the skin (subcutaneously). It is not known whether PDSS can happen with WELTRUZA. PDSS with an extended-release intramuscular injection has led to hospitalization, has happened within the first 3 hours of injection, but also happened after 3 hours of injection, and has the risk each time an injection is received. Tell your healthcare provider right away or go to the nearest emergency room if you get signs or symptoms of PDSS, including more sleepiness than usual, dizziness, confusion or disorientation, trouble walking or talking, stiff muscles or shakiness, weakness, feeling grouchy or angry, feeling anxious or nervous, increased blood pressure, seizures (convulsions), or passing out.Strokes in elderly people (cerebral problems) that can lead to death.Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, stiff muscles, confusion, changes in pulse, heart rate, or blood pressure, increased sweating.Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is an allergic reaction that can cause death that may affect your skin or other parts of your body including your liver, kidney, lungs, or heart. Contact your healthcare provider right away if you experience any signs or symptoms of DRESS, including fever, skin rash or blistering or peeling skin, swelling of face, glands, or other body parts, cough or trouble breathing, chest pain, yellowing of the skin or eyes, dark urine or changes in urination.Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk of diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with WELTRUZA. Call your healthcare provider if you have symptoms of high blood sugar, including feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving WELTRUZA. Tell your healthcare provider if you get any body movements that you cannot control.Decreased blood pressure (orthostatic hypotension). You may feel dizzy or lightheaded, get a fast or slow heartbeat, or faint, when you rise too quickly from a sitting or lying position. Drinking alcohol and using other medicines that make you dizzy can increase your risk for orthostatic hypotension. Avoid drinking alcohol during treatment with WELTRUZA.Falls. WELTRUZA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.Low white blood cell counts. Your healthcare provider may do white blood cell count tests during your first few months of treatment with WELTRUZA.Difficulty swallowing that can cause food or liquid to get into your lungs.Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive, operate machinery, or do other dangerous activities until you know how WELTRUZA affects you.Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated.Certain side effects from the way WELTRUZA works in your body such as constipation, dry mouth, fast heartbeat, urinary retention, or prostate and bowel problems. Your risk is increased if you take other medicines that also cause these side effects.Increased prolactin levels in your blood (hyperprolactinemia). WELTRUZA can cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.The most common side effects of olanzapine in patients with schizophrenia include weight gain, sleepiness, headache, and constipation. Injection site reactions, including hardness, pain, redness, itching, and swelling, were reported with WELTRUZA.
These are not all the possible side effects with WELTRUZA. Tell your healthcare provider if you have any side effect that does not go away. For more information, ask your healthcare provider or pharmacist.
Before receiving WELTRUZA, tell your healthcare provider about all of your medical conditions, including if you:
have or had diabetes or high blood sugarhave or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low HDL levels in your bloodhave or had low or high blood pressurehave or had heart problems or strokeare dehydratedhave or had a low white blood cell counthave or had seizures (convulsions)have or had problems with urination or prostate problemshave Alzheimer’s diseasehave or had constipation or bowel obstructionhave or had breast cancerare pregnant or plan to become pregnant. WELTRUZA may harm your unborn baby. Receiving WELTRUZA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms such as agitation, stiffness or floppiness, tremors, sleepiness, and breathing or feeding problems after birth. Talk to your healthcare provider about the risks to your baby if you receive WELTRUZA during pregnancy.If you become pregnant during treatment with WELTRUZA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.are breastfeeding or plan to breastfeed. WELTRUZA passes into breast milk. If you breastfeed during treatment with WELTRUZA, tell your healthcare provider if your baby is very sleepy, irritable, is feeding poorly, or gets tremors or abnormal muscle movements. Talk to your healthcare provider about the best way to feed your baby during treatment with WELTRUZA.Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: blood pressure medicines, levodopa or dopamine, or other olanzapine medicines. Your healthcare provider can tell you if it is safe to receive WELTRUZA with your other medicines.
Do not start or stop any medicines during treatment with WELTRUZA without talking to your healthcare provider first.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For more information about WELTRUZA, see the full Prescribing Information, including Medication Guide and Boxed WARNING, or talk to your healthcare provider.
About Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS)
SOLARIS was an 8 week, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.1 For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (WELTRUZA) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.1 For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI (WELTRUZA) treatment groups, while patients who completed period one on active olanzapine LAI (WELTRUZA) remained on their established dose strength.1 The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.1 The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia, as measured by PANSS.1 A key secondary objective was to further evaluate the efficacy of olanzapine LAI (WELTRUZA) based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP.1 A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia.1
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.4 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.4,5,6 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.1 million people in the U.S. are currently diagnosed with the condition.3,4,5 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men and the late 20s to early 30s for women.4 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.6 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness and changes in brain morphology.7,8,9 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates and, ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.4,5,6,7,8,9
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize WELTRUZA for the treatment of schizophrenia in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; financial, economic and other risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Other Information.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Data on file. [CSR/SOLARIS]. West Chester, PA: Teva Neuroscience, Inc.Data on file. [TRx data sourced from IQVIA NPA Full Year 2025; orals factored for SCZ using Analytics Link 2022.] Parsippany, NJ: Teva Neuroscience, Inc.Data on file. [DRG/Clarivate (Nov 2025 Market Forecast Assumptions-Schizophrenia)]. Parsippany, NJ: Teva Neuroscience, Inc.Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.Teva Media Inquiries: [email protected]
Teva Investor Relations Inquiries: [email protected]
Based on a post hoc analysis, a majority of participants (~70%) experienced clinically meaningful tic reduction within 8 weeks of starting ecopipamAn interim 18-month analysis of an ongoing open-label extension study demonstrated a mean reduction in tic severity scores (45.6%) with no new safety signals observedAdditional analyses found that common concurrent psychiatric conditions did not negatively impact ecopipam’s efficacy or safety, adding to the growing body of evidence supporting ecopipam’s application currently under FDA Priority Review PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data for ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome. Presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Seoul, South Korea (October 4–8, 2026), the data include a post hoc analysis of safety and efficacy during the initial 8 weeks of treatment with ecopipam, long-term efficacy and safety from an interim analysis of an ongoing open-label extension (OLE) study, post hoc subgroup analyses and preclinical receptor selectivity findings.
“Tourette syndrome is a complex neurodevelopmental disorder that presents significant daily challenges for children and their families,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “These promising new data for ecopipam reinforce our confidence in its potential in pediatric Tourette syndrome care. If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first with a novel mechanism of action in more than 50 years.”
Key Findings from Studies Include:
Tic Severity Reduction Observed Within Two Months of Treatment: In a pooled post hoc analysis of 292 patients across Phase 2b and Phase 3 trials, a clinically meaningful improvement in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) (score ≥25%) was observed in 69.8% of participants within the first eight weeks of treatment with ecopipam. The most commonly reported adverse events (AEs) were somnolence and headache, and the most commonly reported cross-trial AEs were most often observed within the first eight weeks of ecopipam exposure.Clinically Meaningful Reduction in Tic Severity Sustained >1 year: An interim analysis of an ongoing 36-month OLE study included patients who completed the phase 3 study and the phase 2b OLE study receiving ecopipam titrated over 3-4 weeks then maintained at a target dose for up to 36 months. The study evaluated 118 children, adolescents and adults with Tourette syndrome who received at least one dose of ecopipam (median treatment exposure of 14.9 months). Ecopipam maintained clinically meaningful tic suppression through 18 months according to the YGTSS-TTS. The most commonly reported AEs were nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia. Co-Occurring Psychiatric Conditions Did Not Impact Efficacy or Safety of Ecopipam: A post hoc analysis evaluated 216 participants (aged ≥6 years) from the Phase 3 trial, comparing outcomes between those with (n=129) and without (n=87) common co-occurring psychiatric conditions, including ADHD, OCD, anxiety and depression. During the 12-week open-label period, the presence of co-occurring conditions did not negatively impact reductions in tic severity, with mean YGTSS-TTS score reductions consistent across participants with ≥1 co-occurring conditions and those without. Overall safety and tolerability profiles were similarly consistent between both groups. “Many children with Tourette syndrome do not receive treatment, and among those who do, treatment is often discontinued within a year because symptoms remain inadequately controlled or side effects become difficult to tolerate,” said Donald L. Gilbert, M.D., M.S., Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Children living with Tourette syndrome urgently need treatment options that work rapidly, remain effective over time and have a demonstrated tolerability profile. These findings are encouraging because they suggest that, if approved, ecopipam may offer patients and families a meaningful new option.”
About Tourette Syndrome
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.2 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.2
About Ecopipam and Its Clinical Program
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.
Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.
The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.3 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.4 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.5 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
References:
U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology.CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025.Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091.Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431 Teva Media Inquiries: [email protected]
The published review examines dopamine’s role in tic generation and how approved and investigational drugs may affect dopamine to reduce tics as well as synthesizes clinical trial evidence that ecopipam reduces tic severity, provides sustained benefit over time and helps prevent relapse without some of the complications associated with antipsychotic agents.¹Ecopipam is an investigational, selective D1 (dopamine) receptor antagonist targeting dopaminergic signaling in the brain’s direct motor pathway implicated in Tourette syndrome.Unlike D2 antipsychotics that target D2 receptors in the indirect pathway, ecopipam selectively targets D1 receptors in the direct motor pathway, offering a differentiated approach that may reduce tic severity while potentially avoiding common adverse events associated with D2-targeting therapies.1 PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the Journal of Child Neurology published a comprehensive review examining dopamine pathways in Tourette syndrome and the therapeutic potential of ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome.1,2 The review evaluates current treatment limitations and details how selectively targeting D1 receptors in the brain’s direct motor pathway may offer a differentiated, non-antipsychotic approach for managing tics in pediatric patients.1
“Tourette syndrome affects up to 1 in 130 children globally and can have a profound impact on a child's daily life, education and social development,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “The review published in the Journal of Child Neurology reinforces the potential of ecopipam’s selective dopamine D1 receptor approach. This is the kind of innovative programs we are pursuing at Teva—advancing differentiated science to address meaningful unmet needs.”
The comprehensive review details the neurobiological rationale for D1 receptor antagonism compared with existing therapies. In Tourette syndrome, elevated dopaminergic activity in the basal ganglia is proposed to contribute to the expression of involuntary tics. Because D1 receptors are primarily expressed by neurons in the direct motor pathway, ecopipam is hypothesized to block excess dopaminergic activity in this pathway, thereby normalizing downstream basal ganglia signaling and movement patterns. In contrast, traditional antipsychotics target D2 receptors, which are primarily associated with the indirect pathway.
This mechanistic distinction is supported by clinical data synthesized across the ecopipam development program. In a Phase 3 trial (n=216, including 167 pediatric), continued ecopipam treatment cut the risk of tic relapse by 50% versus placebo in pediatric participants (HR: 0.5; P=0.008), building on Phase 2b and 12-month open-label data showing sustained reductions in tic severity. Across clinical trials, the most common adverse events included somnolence, headache, insomnia, fatigue and anxiety while ecopipam was not associated with clinically relevant weight gain, adverse metabolic effects or drug-induced movement disorders. The potential importance of this efficacy and tolerability profile is underscored by real-world treatment persistence data, which show that treatment discontinuation rates among patients newly treated with D2 receptor antagonists were 61.2% by 3 months and 82.1% by 18 months.1
“Treatment of Tourette syndrome can be complex, as clinicians must balance tic improvement with the side effect profiles of current therapies,” said Donald L. Gilbert, M.D., M.S., senior author of the review and Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Ecopipam selectively targets the dopamine D1 receptor, and the data reviewed in this publication – demonstrating reduced tic severity and sustained benefit without significant weight gain, metabolic complications or movement disorders – supports continued research into D1 receptor antagonism for Tourette syndrome.”
For more information on the review published online in the Journal of Child Neurology, click here.
About Tourette Syndrome
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.3 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.3
About Ecopipam and Its Clinical Program
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.
Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.
The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.4 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.5 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.6 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
References:
Karkanias, G. B., Flatt, J. A., Korb, R. T., Munschauer, F. E., Wanaski, S. P., Cunniff, T. M., & Gilbert, D. L. (2026). Targeting Dopamine Pathways for the Treatment of Tourette Syndrome. Journal of Child Neurology. https://doi.org/10.1177/08830738261491159U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574 Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431 Teva Media Inquiries: [email protected]
The agreement covers SB41, a potential biosimilar candidate referencing Fasenra® (benralizumab), and SB44, a potential biosimilar candidate referencing Ilaris® (canakinumab) with an option for 4 additional assetsThe partnership will cover development and commercialization in the United States, Europe, and Canada, with an option to expand to other territoriesThe partnership brings together Samsung Bioepis’ development, regulatory and manufacturing capabilities with Teva’s global commercial reach to advance the investigational biosimilar candidates and help bring additional important treatment options to patients worldwide INCHEON, Korea & TEL AVIV, Israel--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the companies have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing Fasenra®1 (benralizumab), and SB44, a biosimilar candidate referencing Ilaris®2 (canakinumab).
This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines
Share Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, and manufacture of the biosimilars, while Teva will be responsible for commercialization in global markets, including the United States (U.S.), Europe, and Canada. The companies have agreed to an option for expanding the partnership to other territories.
This agreement reinforces the long-standing and successful partnership between Samsung Bioepis and Teva, which has already resulted in the successful commercialization of EPYSQLI® (eculizumab-aagh) in the U.S. The companies have also expanded that agreement further to include OPUVIZ® (aflibercept) in Canada. The expanded collaboration reflects a shared approach to combining complementary capabilities for broadening access to biosimilar medicines across global markets.
“We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.”
Richard Francis, President and CEO of Teva said, “Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company. This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the U.S. By combining a strong and growing portfolio and our excellent global commercial capabilities, we are strengthening our leadership position in biosimilars and our ability to bring more treatment options to patients around the world.”
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit https://www.tevapharm.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “may,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully execute the license, development and commercialization agreement with Samsung Bioepis; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ending December 31, 2025, including in the section captioned “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
1 Fasenra is a trademark of AstraZeneca AB.
2 Ilaris is a trademark of Novartis AG.
TEL AVIV, Israel, Sept. 30, 2026 (GLOBE NEWSWIRE) -- TAPI (Technology & API Services) today announced the appointment of Serge Rogasik as its Chief Executive Officer. Mr. Rogasik will lead a global business that combines a broad API portfolio, deep scientific and technical capabilities, and an extensive global operations network serving customers worldwide.
“I am honored to join TAPI at such an important moment in its evolution," said Mr. Rogasik. "TAPI combines a unique set of capabilities, assets and talented people with a well-earned reputation as a trusted partner to customers worldwide. As the pharmaceutical industry increasingly focuses on supply chain resilience and geographic diversification, TAPI is uniquely positioned to support its customers. Few companies can match one of the industry's broadest technology platforms and an integrated manufacturing and R&D network spanning India, the Middle East, Europe and the Americas. I am excited by the momentum in the business and see significant opportunities ahead to further strengthen TAPI's position as a leading integrated API and CDMO partner.”
Founded in 1935, TAPI is one of the world’s largest producers of active pharmaceutical ingredients and a leading CDMO partner with more than 4,000 employees, 13 manufacturing sites and six R&D facilities, supplying more than 350 active ingredients to customers around the world. Through its API and CDMO businesses, TAPI helps customers bring effective medicines to patients around the world.
Mr. Rogasik and the TAPI team will be at CPHI Milan, October 6–8, 2026, in Hall 3, Booth A73. Customers and partners are invited to stop by to meet him and the teams behind TAPI's catalog and CDMO businesses.
About Serge Rogasik
Mr. Rogasik is a transformation-focused global executive with more than 25 years of experience building, scaling and repositioning businesses across specialty ingredients, active ingredients, specialty chemicals and life sciences. He has spent a significant part of his career leading private equity-backed companies through complex carve-outs, accelerated growth, portfolio transformation, M&A and operational improvement in highly regulated markets – building stronger, more focused businesses that deliver sustainable long-term value. Most recently, as President and Chief Executive Officer of Kensing, a specialty ingredients company owned by One Rock Capital Partners, he helped transform a single-site carve-out from BASF into a global platform serving the personal care, nutrition, pharmaceutical and agrochemical markets. Under his leadership, Kensing integrated four acquisitions, expanded its global footprint and became the world leader in natural vitamin E and sterols.
Prior to Kensing, Mr. Rogasik led growth and transformation initiatives at Vantage Specialty Chemicals and Addivant, where he helped turn carve-outs and underperforming businesses into stronger, more focused global platforms through commercial expansion, operational improvement and strategic acquisitions. Earlier in his career, he held senior strategy, commercial, marketing and research roles with BASF, General Electric, Eastman Chemical Company, Rhône-Poulenc and Colgate-Palmolive, building deep international experience across specialty chemicals, life sciences and consumer markets.
Mr. Rogasik holds a Master of Science in Industrial Pharmacy and a postgraduate degree in Pharmaceutical Industry Management from the Institut des Sciences Pharmaceutiques et Biologiques de Lyon. Since 2023, he has served as Chairman of the International Association of Sterol and Stanol Producers and previously served on the Board of Directors of World Child Cancer USA.
About TAPI
TAPI is a global leader in the development and manufacturing of active pharmaceutical ingredients (APIs), building blocks and key starting materials (KSMs) providing one of the industry's most comprehensive API portfolios. TAPI also offers customized CDMO services, utilizing their extensive expertise in a wide range of technologies to meet the diverse needs of partners, ensuring flexibility and excellence in every project. With 4,100 employees, a global footprint in 100+ countries, 13 sites worldwide, and a robust portfolio of 350+ high-quality products, TAPI's operations are integral to the delivery of high-quality, safe and effective medications to patients worldwide, supported by a sophisticated supply chain, focused innovative manufacturing, regulatory and quality excellence and a commitment to sustainability. For more information about how TAPI is advancing health from the core, visit www.tapi.com.
Teva Cautionary Note Regarding Forward-Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “may,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully execute TAPI’s next phase of growth and anticipated business performance; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward-looking statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Photos accompanying this announcement are available at
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Serge Rogasik TAPI (Technology & API Services) Names Serge Rogasik CEO to lead next chapter of growth and competit... TAPI Steroid manufacturing TAPI Steroid manufacturing
Key Takeaways Teva expects branded products to reach 22% of revenues in 2026, up from 9% in 2022.Teva expects Austedo revenues of $2.45-$2.60 billion in 2026, with growth aided by Austedo XR.Teva plans five regulatory submissions through 2030, including olanzapine, ecopipam and duvakitug. Teva Pharmaceutical Industries Limited’s (TEVA - Free Report) business was heavily dependent on generic medicines for decades. That model provided scale but also exposed the company to intense price competition, product commoditization and periodic revenue declines when additional generic competitors entered the market.
Under its "Pivot to Growth" strategy, launched in 2023, Teva is strengthening the branded drugs segment by investing in research and development, pursuing targeted acquisitions and partnerships, and expanding its commercial capabilities in specialty therapeutic areas. This shift is not about abandoning generics; rather, Teva is trying to use the cash flow and commercial infrastructure of its generics business to fund a growing branded-drug franchise. Rather than attempting to compete across numerous disease categories, Teva has concentrated on areas where it possesses scientific expertise and can establish meaningful market positions, including neuroscience, immunology and respiratory diseases.
Teva’s Innovative/Branded Drugs Deliver Strong GrowthThe company is seeing continued market share growth of its newest branded drugs, Austedo, Ajovy and Uzedy. Collectively, sales of the three drugs rose 43% year over year to more than $1 billion in the second quarter. Teva expects their combined sales to reach approximately $3.7 billion in 2026, representing around 17% growth at the midpoint.
Austedo remains the largest contributor to the franchise, with global sales rising 40% year over year to $696 million in the second quarter. Teva expects Austedo revenues of $2.45-$2.60 billion in 2026, with the midpoint broadly matching its previous target of more than $2.5 billion by 2027. This could put the drug roughly a year ahead of schedule. The Austedo franchise got a boost from the launch of Austedo XR, a new once-daily formulation of Austedo. Teva launched Austedo in European markets in 2026, which should further contribute to growth. Teva expects Austedo revenues to exceed $3 billion by 2030.
Teva's second important growth product is Ajovy, a CGRP-targeting medicine for migraine prevention. Ajovy’s global revenues increased 56% on a constant-currency basis to $244 million in the second quarter. Teva expects Ajovy sales of $850-$870 million in 2026, and estimates peak global sales potential of approximately $1 billion.
Another important branded asset is Uzedy, a long-acting injectable treatment for schizophrenia. Management believes Uzedy has substantial long-term potential because long-acting injectable antipsychotics are increasingly being adopted in psychiatric care. Uzedy revenues increased 43% year over year to $77 million in the second quarter, with full-year 2026 sales expected to reach $270-$290 million.
Pipeline Could Further Expand Teva’s Innovative FranchiseThe bigger question is whether Teva can continue this transition after the current three growth brands mature.
The company has several key branded pipeline assets in neuroscience and immunology, which it believes represent a multi-billion-dollar commercial opportunity. These include olanzapine LAI, a long-acting subcutaneous injectable for schizophrenia, and ecopipam, which was acquired through Emalex Biosciences and is being developed for pediatric Tourette syndrome. Both candidates are under U.S. regulatory review, with Teva targeting potential launches of olanzapine LAI in the fourth quarter of 2026 and ecopipam in the first half of 2027, subject to approval.
Another key pipeline asset is duvakitug, a late-stage anti-TL1A therapy being developed for inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. Teva has partnered with Sanofi (SNY - Free Report) for duvakitug to maximize the value of the asset. Teva and Sanofi will equally share the development costs globally. On the second-quarter conference call, Teva announced plans to begin studies for duvakitug in two additional indications — hidradenitis suppurativa and fibrostenotic Crohn’s Disease. It believes duvakitug has pipeline-in-a-product potential.
Teva plans to make five regulatory submissions for its branded candidates over the next five years: olanzapine in 2026, ecopipam in 2027, followed by Dual Action Rescue Inhaler (a dry powder inhaler for asthma), emrusolmin (multiple system atrophy) and duvakitug between 2028 and 2030.
In 2022, only about 9% of Teva’s revenues came from its branded drugs. Teva now expects it to reach 22% of total revenues in 2026. Teva anticipates generating more than $5 billion in revenues from its branded products by 2030 compared with more than $3 billion in 2025.
ConclusionTeva’s branded portfolio is becoming an increasingly important growth driver, reducing its reliance on traditional generics. Strong sales of Austedo, Ajovy and Uzedy, along with upcoming launches and a promising pipeline, should support further growth in branded revenues. If Teva executes successfully, branded drugs could account for a steadily larger share of its business through 2030. At the same time, Teva’s generic portfolio will remain an important source of scale and cash flow to support investments in branded medicines.
TEVA’s Price, Valuation & Estimate DiscussionShares of Teva have rallied 24.6% so far this year compared with the industry’s 6.9% growth.
Image Source: Zacks Investment Research
The stock is trading at a decent valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 13.72 on a forward 12-month basis, lower than 15.73 for the industry. However, the stock is trading above its five-year mean of 5.69.
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The Zacks Consensus Estimate for earnings per share has declined from $2.06 to $2.03 for 2026 over the past 60 days and from $3.14 to $3.11 for 2027.
Image Source: Zacks Investment Research
TEVA’s Zacks Rank & Stocks to ConsiderTeva has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Amarin (AMRN - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for AC Immune’s 2026 bottom line have improved from a loss of 84 cents per share to a loss of 60 cents per share. For 2027, earnings estimates have been stable at 17 cents per share over the same timeframe. ACIU shares have lost 16.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, the average surprise being 33.25%.
Over the past 60 days, loss estimates for Amarin have improved from 65 cents per share to 39 cents per share, while those for 2027 have improved from a loss of 51 cents per share to 50 cents. AMRN shares have declined 5.1% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters, while missing in one, with the average surprise being 65.44%.
Teva Pharmaceuticals (TEVA -0.79%) recently hit a new 52-week high of $40.79 per share and has surged 110% in the last year. It's the drugmaker's turnaround, fueled by a pivot from generic to branded products, driving this mega rally among pharmaceutical stocks.
To some, it still doesn't make sense that Teva surged so far, so fast, given that the company has yet to see a big jump in revenue or earnings. However, a closer look at three company metrics makes it clear why investors continue to bid shares higher.
Image source: Getty Images.
$3.7 billion: forecasted sales for Teva's new drugs Teva's "Innovative Portfolio" of branded drugs so far consists of three products: Austedo, Uzedy, and Ajovy. During Q2 2026, these three products combined to generate just over $1 billion in revenue. For the full year 2026, management anticipates sales for the three totaling $3.7 billion.
This is only around 22% of Teva's estimated 2026 sales. However, management guides for further "Innovative Portfolio" growth, to the point where it has a significant impact on company-wide gross margins.
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$12.9 billion: Teva's outstanding debt position As of June 30, 2026, Teva's net outstanding debt was $12.9 billion. Compare that to the end of 2022, when Teva's net debt totaled $18.4 billion.
The company also recently received a credit rating upgrade, which raised its long-term issuer rating from BB- to BBB-. With its debt moving from "junk" to investment-grade status, Teva is now well positioned to refinance its remaining debt at lower interest rates.
$10 billion: the potential for Teva's drug pipeline Between the company's existing pipeline and the candidates gained through its recent acquisition of Emalex Biosciences, the company anticipates peak annual sales of at least $10 billion from its late-stage pipeline portfolio.
Just between 2026 and 2027, analysts expect the company's earnings to grow 40.7%, from $2.16 to $3.04 per share. Considering the prospect of even greater earnings growth in subsequent years, shares arguably appear cheap at just 12.9 times next year's forecast earnings.
DEGEVMA™ is now FDA-approved across all indications of the reference product, Xgeva® (denosumab), to help prevent bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.FDA approval of DEGEVMA marks another milestone in Teva’s Pivot to Growth strategy, demonstrating our ability to bring high-quality, more affordable treatment options to patients across complex therapeutic categories.DEGEVMA is Teva’s second FDA-approved biosimilar in 2026 and, together with PONLIMSI™ (denosumab-adet), establishes Teva's comprehensive denosumab biosimilar portfolio across the indications of the reference products Xgeva® and Prolia® (denosumab). TEL AVIV, Israel, and PARSIPPANY, N.J., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab). DEGEVMA is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.
The FDA approval of DEGEVMA, together with PONLIMSI (denosumab-adet), which was approved by the FDA in March 2026, establishes a comprehensive U.S. denosumab biosimilar portfolio spanning the indications of both Xgeva® and Prolia® (denosumab), respectively. Now, healthcare professionals and patients are able to gain expanded access to biologic treatment options in oncology-related bone disease and osteoporosis care.
“Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs,” said Rob Cook, Head of Global Technical Development & Generics R&D at Teva. “The approval of DEGEVMA reflects the scientific, clinical and regulatory expertise behind our in-house biosimilars capabilities and our continued focus on expanding access to important biologic medicines.”
Biologics like denosumab represent a significant portion of healthcare expenditures, particularly in oncology. The introduction of biosimilars is critical to driving down systemic healthcare costs while broadening patient access to complex, life-enhancing medications.
“The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “The approval of DEGEVMA is a powerful example of Teva’s Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar.”
The FDA approval of DEGEVMA was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety and immunogenicity profile as the reference product, Xgeva®. DEGEVMA is a human monoclonal antibody that binds to the RANKL protein, an essential regulator of osteoclast formation, function and survival. By inhibiting RANKL, DEGEVMA decreases bone resorption and cancer-induced bone destruction. The comprehensive data package submitted to the FDA demonstrated that DEGEVMA has no clinically meaningful differences from the reference product in terms of safety, purity and potency.
Teva anticipates launching DEGEVMA and PONLIMSI in the U.S. in the coming months, aligning with its broader biosimilar commercialization strategy.
DEGEVMA is currently approved in the European Union (EU). Learn more about Teva’s global biosimilars portfolio and commercialization capabilities at www.tevabiosimilars.com.
Use of Trademarks
Xgeva® and Prolia® are registered trademarks of Amgen, Inc.
About DEGEVMA
DEGEVMA (denosumab) is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.
The active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein RANKL, essential for the formation, function, and survival of osteoclasts—the cells responsible for bone resorption. By binding to RANKL with high affinity and specificity, denosumab prevents the interaction between RANKL and RANK, leading to a decrease in bone resorption in cortical and trabecular bone.
DEGEVMA will be available as a 120mg/1.7mL solution for injection in a vial.
DEGEVMA is a biosimilar medicinal product, similar to the reference product Xgeva® (denosumab), which was approved in the EU on November 18, 2025.
Comprehensive analytical, preclinical, and clinical data demonstrate that DEGEVMA has comparable quality, safety and efficacy to the reference product.
INDICATIONS
DEGEVMA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
DEGEVMA is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
DEGEVMA is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Pre-existing hypocalcemia must be corrected prior to initiating therapy with DEGEVMA.
DEGEVMA is contraindicated in patients with known clinically significant hypersensitivity to DEGEVMA or denosumab products.
WARNINGS AND PRECAUTIONS
Drug Products with Same Active Ingredient
Patients receiving DEGEVMA should not receive other denosumab products.
Hypersensitivity
Clinically significant hypersensitivity including anaphylaxis has been reported with use of DEGEVMA. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue DEGEVMA therapy permanently.
Hypocalcemia
DEGEVMA can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to DEGEVMA treatment. Monitor calcium levels, throughout DEGEVMA therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare provider for symptoms of hypocalcemia. Do not take DEGEVMA if you are allergic to denosumab or any of the ingredients of DEGEVMA.
An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.
Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving DEGEVMA, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure. Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a higher risk of developing ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.
Perform an oral examination and appropriate preventive dentistry prior to the initiation of DEGEVMA and periodically during DEGEVMA therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with DEGEVMA. Consider temporary discontinuation of DEGEVMA therapy if an invasive dental procedure must be performed.
Patients who are suspected of having or who develop ONJ while on DEGEVMA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.
Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fracture has been reported with DEGEVMA. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.
Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral, and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture.
During DEGEVMA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of DEGEVMA therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons
Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in DEGEVMA-treated patients with giant cell tumor of bone and patients with growing skeletons. Within the first year after treatment discontinuation, monitor patients for signs and symptoms of hypercalcemia and treat appropriately.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures.
When DEGEVMA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.
Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman.
Advise pregnant women and females of reproductive potential that exposure to DEGEVMA during pregnancy or within 5 months prior to conception can result in fetal harm.
ADVERSE REACTIONS
The most common adverse reactions in patients with bone metastases from solid tumors taking DEGEVMA were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious side effect was dyspnea.
In patients with multiple myeloma, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious side effect of DEGEVMA was osteonecrosis of the jaw.
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information for DEGEVMA.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “may,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully commercialize DEGEVMA (denosumab-adet) a Biosimilar to Xgeva® (denosumab) for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone, and for the treatment of hypercalcemia of malignancy, and PONLIMSI (denosumab-adet); our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors” and “Forward-looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
QRG Capital Management Inc. grew its holdings in Teva Pharmaceutical Industries Ltd. (NYSE:TEVA – Free Report) by 17.0% during the second quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The firm owned 89,078 shares of the company’s stock after purchasing an additional 12,925 shares during the period. QRG Capital Management Inc.’s holdings in Teva Pharmaceutical Industries were worth $3,018,000 as of its most recent SEC filing.
Other large investors have also recently added to or reduced their stakes in the company. Cornerstone Planning Group LLC boosted its position in Teva Pharmaceutical Industries by 547.1% during the first quarter. Cornerstone Planning Group LLC now owns 893 shares of the company’s stock worth $27,000 after purchasing an additional 755 shares during the period. Allworth Financial LP lifted its position in shares of Teva Pharmaceutical Industries by 53.8% during the 4th quarter. Allworth Financial LP now owns 941 shares of the company’s stock worth $29,000 after purchasing an additional 329 shares during the last quarter. EverSource Wealth Advisors LLC boosted its stake in Teva Pharmaceutical Industries by 51.8% during the 4th quarter. EverSource Wealth Advisors LLC now owns 1,011 shares of the company’s stock valued at $32,000 after purchasing an additional 345 shares during the period. Western Wealth Management LLC acquired a new stake in Teva Pharmaceutical Industries in the 1st quarter valued at approximately $43,000. Finally, Sunbelt Securities Inc. bought a new position in Teva Pharmaceutical Industries in the 1st quarter worth approximately $45,000. Institutional investors and hedge funds own 54.05% of the company’s stock.
Teva Pharmaceutical Industries Stock Performance Shares of Teva Pharmaceutical Industries stock opened at $39.15 on Friday. The company has a debt-to-equity ratio of 1.56, a current ratio of 0.88 and a quick ratio of 0.67. The firm has a market cap of $45.62 billion, a price-to-earnings ratio of 65.25, a price-to-earnings-growth ratio of 3.83 and a beta of 0.87. The stock’s 50-day moving average is $36.18 and its 200-day moving average is $33.80. Teva Pharmaceutical Industries Ltd. has a one year low of $18.27 and a one year high of $40.79.
Teva Pharmaceutical Industries (NYSE:TEVA – Get Free Report) last issued its quarterly earnings results on Tuesday, June 30th. The company reported $0.02 earnings per share (EPS) for the quarter. The firm had revenue of $4.14 billion for the quarter. Teva Pharmaceutical Industries had a net margin of 4.08% and a return on equity of 32.64%. Equities analysts predict that Teva Pharmaceutical Industries Ltd. will post 1.94 earnings per share for the current fiscal year. Insider Buying and Selling In other news, Director Roberto Mignone sold 367,600 shares of the business’s stock in a transaction dated Friday, September 18th. The shares were sold at an average price of $39.06, for a total value of $14,358,456.00. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through this hyperlink. Also, insider Brian Savage sold 7,342 shares of the company’s stock in a transaction dated Friday, September 18th. The shares were sold at an average price of $38.85, for a total transaction of $285,236.70. Following the completion of the transaction, the insider owned 8,500 shares in the company, valued at $330,225. This trade represents a 46.35% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. Over the last ninety days, insiders sold 374,959 shares of company stock valued at $14,644,285. Insiders own 0.54% of the company’s stock.
Analysts Set New Price Targets Several research firms recently issued reports on TEVA. UBS Group increased their price target on shares of Teva Pharmaceutical Industries from $42.00 to $48.00 and gave the stock a “buy” rating in a research report on Friday, September 4th. Piper Sandler lifted their price objective on Teva Pharmaceutical Industries from $42.00 to $44.00 and gave the company an “overweight” rating in a report on Tuesday, July 28th. Barclays boosted their target price on shares of Teva Pharmaceutical Industries from $40.00 to $42.00 and gave the company an “overweight” rating in a research note on Wednesday, August 12th. Oppenheimer initiated coverage on shares of Teva Pharmaceutical Industries in a research report on Wednesday. They set an “outperform” rating and a $50.00 target price for the company. Finally, Wall Street Zen downgraded shares of Teva Pharmaceutical Industries from a “buy” rating to a “hold” rating in a report on Sunday, July 12th. Eleven analysts have rated the stock with a Buy rating and one has issued a Hold rating to the company’s stock. According to data from MarketBeat, the company has an average rating of “Moderate Buy” and an average price target of $43.73.
Read Our Latest Stock Report on TEVA
Teva Pharmaceutical Industries Company Profile (Free Report)
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva’s specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
See Also Five stocks we like better than Teva Pharmaceutical Industries Costco Ends Its Fiscal Year on a High Note, Eyes Big Expansion Cracker Barrel Stock Is Rallying Again, But the Turnaround Still Has a Traffic Problem Oracle’s Force Majeure Notice Exposes a Bigger Problem for the AI Build-Out Oil May Be Stronger Than It Looks—And Diamondback Is on Sale Want to see what other hedge funds are holding TEVA? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Teva Pharmaceutical Industries Ltd. (NYSE:TEVA – Free Report).
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Teva Pharmaceutical Industries (NYSE:TEVA) is planning for greater financial flexibility after receiving investment-grade ratings from all three major credit rating agencies, President and CEO Richard Francis said at the BofA Global Healthcare Conference.
Francis said the company achieved the milestone about a year earlier than its prior target of the end of 2027. He said the upgrades reflected not only debt reduction, but also rating agencies’ expectations for future EBITDA growth.
“It’s not that we paid down the debt and now what?” Francis said. “It’s the future of the company looks a lot better.” Teva’s previous capital-allocation priorities included reducing debt, investing in commercial growth drivers and product launches, advancing its pipeline and business development efforts, and returning capital to shareholders. With debt reduction becoming less of a primary focus, Francis said Teva is assessing how to deploy cash toward the remaining priorities.
Business Development Focuses on Innovative Assets Francis said Teva remains active in business development but will maintain a disciplined approach to pricing and investment returns. The company has completed one transaction involving Amylyx and is also evaluating potential opportunities related to Biohaven, which is in bankruptcy, he said.
Teva expects the majority of business-development spending to be directed toward innovative medicines, particularly in central nervous system and neurology areas such as psychiatry and movement disorders. The company may also pursue immunology opportunities and rare diseases, Francis said. Rare disease opportunities could be evaluated across therapeutic areas because they can leverage Teva’s commercial, supply-chain and pricing capabilities.
The company will continue to invest in its generics business as well, particularly biosimilars. Francis said Teva has 15 biosimilars on the market and another 14 in its pipeline.
Francis also said Teva expects its debt refinancing to reduce financing expenses by approximately $400 million next year, providing additional cash-flow flexibility.
Pipeline Strategy Emphasizes Probability of Success Teva’s research strategy focuses on validated biological targets rather than discovering entirely new targets or mechanisms of action, according to Francis. He described the company’s approach as “little R, capital D,” emphasizing development capabilities, including antibody engineering, over early discovery.
Francis cited Teva’s TL1A program, duvakitug, its anti-IL-15 antibody program and a TSLP/IL-13 program as examples of assets where the company believes antibody optimization can improve efficacy, tolerability and safety. Teva expects data from its anti-PD-1/IL-2 program by the end of the year, he added.
For central nervous system programs, Teva is willing to partner externally when scientific evidence has helped validate a target or pathway. Francis said the company has monitored potential opportunities globally, including in China, and is not “precious” about whether pipeline assets originate internally or externally.
He said duvakitug and the anti-IL-15 asset could each support multiple indications. Duvakitug is currently being evaluated in four indications, with Teva potentially adding several more, while the anti-IL-15 program is being developed in vitiligo and celiac disease, with alopecia planned to follow.
Teva expects to launch roughly five innovative products during the next five years and potentially introduce another product every 12 to 18 months thereafter, Francis said, contingent on clinical and regulatory outcomes.
Celiac, Vitiligo and Duvakitug Development Francis acknowledged that Teva’s previously discussed $1 billion peak-sales potential for individual pipeline assets may prove conservative for celiac disease and vitiligo. However, he said the company had used the figure to illustrate that its pipeline represents more than $13 billion in potential sales even under a methodical framework.
Teva is discussing the development path for celiac disease with the Food and Drug Administration, Francis said. While the company intends to move quickly, he said it must first align with the FDA on endpoints and other regulatory expectations because no drug has previously been developed for celiac disease.
For duvakitug in inflammatory bowel disease, Francis said Teva sees potential for differentiated efficacy but stressed that phase 3 results will be required. He said safety and tolerability could be important differentiators in chronic conditions where other treatments may carry black-box warnings or monitoring requirements.
2027 Launches and Generics Outlook Francis said Teva’s long-acting olanzapine program remains on its expected regulatory-review timeline. If approved, he expects the product to have a stronger launch than UZEDY, though revenue could build more meaningfully in the second half of the following year due to the need for state-by-state Medicaid formulary access.
The company expects to have about 86% Medicaid coverage after 12 months, he said. Teva plans to emphasize sampling, physician adoption, hospital formulary inclusion and prescription growth while it works through reimbursement access.
Francis also expressed optimism about the planned first-quarter launch of ecopipam for Tourette’s syndrome. Teva is still evaluating pricing and access strategy for the product, which is aimed at a market where he said many patients are dissatisfied with current treatment options.
Finally, Francis said Teva’s U.S. generics business appears more stable. He said the company’s generics operations have moved from years of decline to a three-year growth CAGR, aided by manufacturing, supply-chain and product-launch improvements. Teva now expects the U.S. generics business to be flat to slightly up this year, compared with an earlier expectation for flat to slightly down performance, supported by biosimilars and newer product launches.
About Teva Pharmaceutical Industries (NYSE:TEVA) Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva’s specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
TEL AVIV, Israel and PARSIPPANY, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that its Q3 2026 Aide Memoire is available on the “Investors” page on its website.
Q3 2026 Aide Memoire
Teva has compiled this document with public information that was previously provided by Teva in order to assist investors ahead of third quarter 2026 results, which are expected to be released on Tuesday, November 3, 2026, at 7:00 a.m. ET, followed by a conference call at 8:00 a.m. ET on the same day. This document is based on Teva’s prior results, management’s previous commentary about Teva’s business outlook and data from select independent sources.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and the Aide Memoire document may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in this press release, and in our Quarterly Report on Form 10-Q for the second quarter of 2026, and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
TEL AVIV, Israel and PARSIPPANY, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its third quarter 2026 financial results on Tuesday, November 3, 2026, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET.
In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on Teva's website at: https://ir.tevapharm.com/Events-and-Presentations.
Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva's website.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
This Document and the presentation at the conference call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026, and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Teva Pharmaceutical Industries Limited (TEVA) Bank of America Global Healthcare Conference 2026 September 23, 2026 5:55 AM EDT
Company Participants
Richard Francis - President, CEO & Director
Conference Call Participants
Jason Gerberry - BofA Securities, Research Division
Presentation
Jason Gerberry
BofA Securities, Research Division
Welcome to the BofA Global Healthcare Conference. It's my pleasure to be introducing Teva Pharmaceuticals and President and CEO, Richard Francis. My name is Jason Gerberry, I'm a Pharma Analyst at BofA. I'll be joining this presentation via tele-presence, unfortunately, but my colleague, Richard Wagner is on-site in person. So the two of us will go through this presentation. So first off, Richard, apologies for not being able to be there in person this year.
Richard Francis
President, CEO & Director
That's okay. Good to have you on the screen, Jason.
Question-and-Answer Session
Jason Gerberry
BofA Securities, Research Division
Great. Well, maybe we can start with a few overarching general questions around Teva's strategy, capital allocation, given the company's recent improvement in its credit profile and overall, just the evolution of the business in the portfolio. So I thought it would be helpful to start with now that Teva has reached investment grade with three credit rating agencies, how does that change the view how the criteria for assets that the company might consider for future BD transactions. I know in the past, there was a laser focus on improving the debt profile. So does this in any way change how you think about maybe capacity? Can the company maybe be more opportunistic on the BD front? So maybe I think that would be a good place to start.
Richard Francis
President, CEO & Director
Yes. Okay. Thank you. So the fact that we got a credit rating of investment grade from all three of the credit rating agencies. And
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA – Get Free Report) Director Roberto Mignone sold 367,600 shares of Teva Pharmaceutical Industries stock in a transaction that occurred on Friday, September 18th. The shares were sold at an average price of $39.06, for a total transaction of $14,358,456.00. The sale was disclosed in a document filed with the SEC, which is accessible through the SEC website.
NYSE:TEVA opened at $39.56 on Wednesday. The firm has a market capitalization of $46.10 billion, a P/E ratio of 65.93, a PEG ratio of 4.99 and a beta of 0.87. Teva Pharmaceutical Industries Ltd. has a 1-year low of $18.21 and a 1-year high of $40.79. The company’s fifty day moving average price is $35.73 and its 200-day moving average price is $33.65. The company has a debt-to-equity ratio of 1.56, a current ratio of 0.88 and a quick ratio of 0.67.
Teva Pharmaceutical Industries (NYSE:TEVA – Get Free Report) last posted its earnings results on Tuesday, June 30th. The company reported $0.02 earnings per share (EPS) for the quarter. The company had revenue of $4.14 billion during the quarter. Teva Pharmaceutical Industries had a net margin of 4.08% and a return on equity of 32.64%. As a group, equities research analysts anticipate that Teva Pharmaceutical Industries Ltd. will post 1.94 EPS for the current year.
Wall Street Analysts Forecast Growth A number of research analysts have weighed in on the stock. UBS Group lifted their price objective on shares of Teva Pharmaceutical Industries from $42.00 to $48.00 and gave the company a “buy” rating in a report on Friday, September 4th. Wall Street Zen downgraded Teva Pharmaceutical Industries from a “buy” rating to a “hold” rating in a research note on Sunday, July 12th. Piper Sandler increased their target price on Teva Pharmaceutical Industries from $42.00 to $44.00 and gave the company an “overweight” rating in a research report on Tuesday, July 28th. Weiss Ratings cut shares of Teva Pharmaceutical Industries from a “hold (c)” rating to a “hold (c-)” rating in a research note on Tuesday, September 8th. Finally, Leerink Partners began coverage on shares of Teva Pharmaceutical Industries in a report on Wednesday, September 9th. They issued an “outperform” rating and a $45.00 price target for the company. Ten research analysts have rated the stock with a Buy rating and one has given a Hold rating to the stock. According to MarketBeat.com, Teva Pharmaceutical Industries currently has an average rating of “Moderate Buy” and a consensus price target of $43.10. View Our Latest Research Report on TEVA
More Teva Pharmaceutical Industries News Here are the key news stories impacting Teva Pharmaceutical Industries this week:
Positive Sentiment: Teva reported new Phase 3 SOLARIS data for investigational once-monthly olanzapine long-acting injectable (LAI) TEV-749 in adults with schizophrenia. The program could strengthen Teva’s central-nervous-system pipeline and provide a future growth opportunity if approved. Teva Pharmaceutical Industries Why Is It Back In The Spotlight Positive Sentiment: At Psych Congress 2026, Teva presented additional analyses from the SOLARIS trial and new data on UZEDY®, its long-acting schizophrenia treatment using Medincell’s drug-delivery technology. The updates support investor interest in Teva’s long-acting injectable franchise, although they do not yet represent regulatory approval. Medincell Partner Teva Presented New Data Neutral Sentiment: Teva’s U.S. All Stars Conference presentation transcript may provide additional commentary on its pipeline and business outlook, but the available report does not identify a specific new catalyst or material change in guidance. Teva Presents at U.S. All Stars Conference Transcript Negative Sentiment: Director Roberto Mignone sold 367,600 Teva shares for approximately $14.36 million. The large transaction, disclosed after Teva’s recent gains, may raise concerns about insider confidence and add near-term selling pressure. SEC Filing for Roberto Mignone Share Sale Negative Sentiment: Insider Brian Savage separately sold 7,342 shares valued at about $285,000, reducing his ownership by 46.35%. While smaller than the director’s sale, the additional insider transaction reinforces the negative sentiment around near-term trading. SEC Filing for Brian Savage Share Sale Institutional Investors Weigh In On Teva Pharmaceutical Industries Hedge funds and other institutional investors have recently made changes to their positions in the stock. Norges Bank purchased a new stake in shares of Teva Pharmaceutical Industries during the fourth quarter worth approximately $1,098,060,000. WCM Investment Management LLC increased its stake in Teva Pharmaceutical Industries by 191.4% in the 1st quarter. WCM Investment Management LLC now owns 40,820,600 shares of the company’s stock valued at $1,157,264,000 after buying an additional 26,813,522 shares during the period. Clal Insurance Enterprises Holdings Ltd raised its position in Teva Pharmaceutical Industries by 18.8% during the 4th quarter. Clal Insurance Enterprises Holdings Ltd now owns 37,404,106 shares of the company’s stock worth $1,171,378,000 after buying an additional 5,917,423 shares during the last quarter. Castle Hook Partners LP purchased a new position in Teva Pharmaceutical Industries during the 4th quarter worth $82,013,000. Finally, Capital World Investors acquired a new stake in shares of Teva Pharmaceutical Industries in the 4th quarter worth $73,687,000. Institutional investors and hedge funds own 54.05% of the company’s stock.
Teva Pharmaceutical Industries Company Profile (Get Free Report)
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva’s specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
Further Reading Five stocks we like better than Teva Pharmaceutical Industries Meta’s Muse Highlights Arm’s Growing Role in AI Infrastructure Oura’s $15.6 Billion IPO Is Betting Investors See More Than a Smart Ring AMD Chips Away at NVIDIA’s AI Throne Is the Fed Playing Chess With Rates—Or Just Behind the Curve Again?
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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA – Get Free Report) insider Brian Savage sold 7,342 shares of the stock in a transaction that occurred on Friday, September 18th. The stock was sold at an average price of $38.85, for a total value of $285,236.70. Following the completion of the transaction, the insider directly owned 8,500 shares in the company, valued at approximately $330,225. This trade represents a 46.35% decrease in their position. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available through this hyperlink.
Teva Pharmaceutical Industries Trading Down 1.3% TEVA opened at $39.56 on Wednesday. The company has a quick ratio of 0.67, a current ratio of 0.88 and a debt-to-equity ratio of 1.56. The stock’s fifty day moving average is $35.73 and its two-hundred day moving average is $33.65. The company has a market capitalization of $46.10 billion, a P/E ratio of 65.93, a PEG ratio of 4.99 and a beta of 0.87. Teva Pharmaceutical Industries Ltd. has a 52 week low of $18.21 and a 52 week high of $40.79.
Teva Pharmaceutical Industries (NYSE:TEVA – Get Free Report) last posted its quarterly earnings results on Tuesday, June 30th. The company reported $0.02 earnings per share (EPS) for the quarter. The business had revenue of $4.14 billion for the quarter. Teva Pharmaceutical Industries had a return on equity of 32.64% and a net margin of 4.08%. Analysts forecast that Teva Pharmaceutical Industries Ltd. will post 1.94 earnings per share for the current year.
Hedge Funds Weigh In On Teva Pharmaceutical Industries Hedge funds and other institutional investors have recently modified their holdings of the stock. Norges Bank purchased a new position in shares of Teva Pharmaceutical Industries during the 4th quarter valued at about $1,098,060,000. WCM Investment Management LLC boosted its stake in shares of Teva Pharmaceutical Industries by 191.4% in the first quarter. WCM Investment Management LLC now owns 40,820,600 shares of the company’s stock worth $1,157,264,000 after buying an additional 26,813,522 shares during the last quarter. Clal Insurance Enterprises Holdings Ltd grew its holdings in Teva Pharmaceutical Industries by 18.8% during the fourth quarter. Clal Insurance Enterprises Holdings Ltd now owns 37,404,106 shares of the company’s stock worth $1,171,378,000 after acquiring an additional 5,917,423 shares during the period. Castle Hook Partners LP acquired a new stake in Teva Pharmaceutical Industries during the fourth quarter worth about $82,013,000. Finally, Capital World Investors purchased a new position in Teva Pharmaceutical Industries during the fourth quarter valued at approximately $73,687,000. 54.05% of the stock is owned by hedge funds and other institutional investors. Wall Street Analyst Weigh In Several equities research analysts have recently commented on the stock. Barclays boosted their price target on shares of Teva Pharmaceutical Industries from $40.00 to $42.00 and gave the company an “overweight” rating in a report on Wednesday, August 12th. Weiss Ratings downgraded shares of Teva Pharmaceutical Industries from a “hold (c)” rating to a “hold (c-)” rating in a research note on Tuesday, September 8th. Piper Sandler boosted their price objective on shares of Teva Pharmaceutical Industries from $42.00 to $44.00 and gave the stock an “overweight” rating in a research note on Tuesday, July 28th. Leerink Partners initiated coverage on Teva Pharmaceutical Industries in a report on Wednesday, September 9th. They set an “outperform” rating and a $45.00 target price for the company. Finally, UBS Group increased their target price on Teva Pharmaceutical Industries from $42.00 to $48.00 and gave the company a “buy” rating in a research report on Friday, September 4th. Ten equities research analysts have rated the stock with a Buy rating and one has assigned a Hold rating to the company’s stock. According to MarketBeat, the company presently has an average rating of “Moderate Buy” and an average price target of $43.10.
Check Out Our Latest Research Report on TEVA
Here are the key news stories impacting Teva Pharmaceutical Industries this week:
Positive Sentiment: Teva reported new Phase 3 SOLARIS data for investigational once-monthly olanzapine long-acting injectable (LAI) TEV-749 in adults with schizophrenia. The program could strengthen Teva’s central-nervous-system pipeline and provide a future growth opportunity if approved. Teva Pharmaceutical Industries Why Is It Back In The Spotlight Positive Sentiment: At Psych Congress 2026, Teva presented additional analyses from the SOLARIS trial and new data on UZEDY®, its long-acting schizophrenia treatment using Medincell’s drug-delivery technology. The updates support investor interest in Teva’s long-acting injectable franchise, although they do not yet represent regulatory approval. Medincell Partner Teva Presented New Data Neutral Sentiment: Teva’s U.S. All Stars Conference presentation transcript may provide additional commentary on its pipeline and business outlook, but the available report does not identify a specific new catalyst or material change in guidance. Teva Presents at U.S. All Stars Conference Transcript Negative Sentiment: Director Roberto Mignone sold 367,600 Teva shares for approximately $14.36 million. The large transaction, disclosed after Teva’s recent gains, may raise concerns about insider confidence and add near-term selling pressure. SEC Filing for Roberto Mignone Share Sale Negative Sentiment: Insider Brian Savage separately sold 7,342 shares valued at about $285,000, reducing his ownership by 46.35%. While smaller than the director’s sale, the additional insider transaction reinforces the negative sentiment around near-term trading. SEC Filing for Brian Savage Share Sale Teva Pharmaceutical Industries Company Profile (Get Free Report)
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva’s specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
Featured Articles Five stocks we like better than Teva Pharmaceutical Industries Meta’s Muse Highlights Arm’s Growing Role in AI Infrastructure Oura’s $15.6 Billion IPO Is Betting Investors See More Than a Smart Ring AMD Chips Away at NVIDIA’s AI Throne Is the Fed Playing Chess With Rates—Or Just Behind the Curve Again?
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MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA is planning for greater financial flexibility after receiving investment-grade ratings from all three major credit rating agencies, President and CEO Richard Francis said at the BofA Global Healthcare Conference.
Francis said the company achieved the milestone about a year earlier than its prior target of the end of 2027. He said the upgrades reflected not only debt reduction, but also rating agencies’ expectations for future EBITDA growth.
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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy Now“It’s not that we paid down the debt and now what?” Francis said. “It’s the future of the company looks a lot better.”
Teva’s previous capital-allocation priorities included reducing debt, investing in commercial growth drivers and product launches, advancing its pipeline and business development efforts, and returning capital to shareholders. With debt reduction becoming less of a primary focus, Francis said Teva is assessing how to deploy cash toward the remaining priorities.
Business Development Focuses on Innovative Assets 2 Generic Drug Stocks Ready to Surge in 2025Francis said Teva remains active in business development but will maintain a disciplined approach to pricing and investment returns. The company has completed one transaction involving Amylyx and is also evaluating potential opportunities related to Biohaven, which is in bankruptcy, he said.
Teva expects the majority of business-development spending to be directed toward innovative medicines, particularly in central nervous system and neurology areas such as psychiatry and movement disorders. The company may also pursue immunology opportunities and rare diseases, Francis said. Rare disease opportunities could be evaluated across therapeutic areas because they can leverage Teva’s commercial, supply-chain and pricing capabilities.
The company will continue to invest in its generics business as well, particularly biosimilars. Francis said Teva has 15 biosimilars on the market and another 14 in its pipeline.
Francis also said Teva expects its debt refinancing to reduce financing expenses by approximately $400 million next year, providing additional cash-flow flexibility.
Pipeline Strategy Emphasizes Probability of Success Teva’s research strategy focuses on validated biological targets rather than discovering entirely new targets or mechanisms of action, according to Francis. He described the company’s approach as “little R, capital D,” emphasizing development capabilities, including antibody engineering, over early discovery.
Francis cited Teva’s TL1A program, duvakitug, its anti-IL-15 antibody program and a TSLP/IL-13 program as examples of assets where the company believes antibody optimization can improve efficacy, tolerability and safety. Teva expects data from its anti-PD-1/IL-2 program by the end of the year, he added.
For central nervous system programs, Teva is willing to partner externally when scientific evidence has helped validate a target or pathway. Francis said the company has monitored potential opportunities globally, including in China, and is not “precious” about whether pipeline assets originate internally or externally.
He said duvakitug and the anti-IL-15 asset could each support multiple indications. Duvakitug is currently being evaluated in four indications, with Teva potentially adding several more, while the anti-IL-15 program is being developed in vitiligo and celiac disease, with alopecia planned to follow.
Teva expects to launch roughly five innovative products during the next five years and potentially introduce another product every 12 to 18 months thereafter, Francis said, contingent on clinical and regulatory outcomes.
Celiac, Vitiligo and Duvakitug Development Francis acknowledged that Teva’s previously discussed $1 billion peak-sales potential for individual pipeline assets may prove conservative for celiac disease and vitiligo. However, he said the company had used the figure to illustrate that its pipeline represents more than $13 billion in potential sales even under a methodical framework.
Teva is discussing the development path for celiac disease with the Food and Drug Administration, Francis said. While the company intends to move quickly, he said it must first align with the FDA on endpoints and other regulatory expectations because no drug has previously been developed for celiac disease.
For duvakitug in inflammatory bowel disease, Francis said Teva sees potential for differentiated efficacy but stressed that phase 3 results will be required. He said safety and tolerability could be important differentiators in chronic conditions where other treatments may carry black-box warnings or monitoring requirements.
2027 Launches and Generics Outlook Francis said Teva’s long-acting olanzapine program remains on its expected regulatory-review timeline. If approved, he expects the product to have a stronger launch than UZEDY, though revenue could build more meaningfully in the second half of the following year due to the need for state-by-state Medicaid formulary access.
The company expects to have about 86% Medicaid coverage after 12 months, he said. Teva plans to emphasize sampling, physician adoption, hospital formulary inclusion and prescription growth while it works through reimbursement access.
Francis also expressed optimism about the planned first-quarter launch of ecopipam for Tourette’s syndrome. Teva is still evaluating pricing and access strategy for the product, which is aimed at a market where he said many patients are dissatisfied with current treatment options.
Finally, Francis said Teva’s U.S. generics business appears more stable. He said the company’s generics operations have moved from years of decline to a three-year growth CAGR, aided by manufacturing, supply-chain and product-launch improvements. Teva now expects the U.S. generics business to be flat to slightly up this year, compared with an earlier expectation for flat to slightly down performance, supported by biosimilars and newer product launches.
About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva's specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Teva Pharmaceutical Industries (NYSE:TEVA) Chief Executive Officer Richard Francis said the company has shifted from being viewed primarily as a generics manufacturer toward a biopharmaceutical company with a growing innovative medicines portfolio, while maintaining and expanding its generics operations.
Speaking with J.P. Morgan analyst Chris Schott, Francis said Teva’s “Pivot to Growth” strategy has centered on accelerating innovative products, stabilizing the generics business, advancing research and development, and maintaining discipline in capital allocation. He said the company’s innovative business grew 40% in the second quarter, while all of its marketed growth products delivered double-digit growth.
Francis said Teva’s innovative sales totaled about $1.2 billion at the end of 2022 and are now running at approximately $1 billion per quarter. He said the company expects to continue growing at a mid-single-digit rate after 2026, while the growing contribution from higher-margin innovative products could support gains in gross margin, operating income, earnings per share and cash flow. Margins and Cost Savings Francis said Teva’s gross margin has risen from 48% when he became CEO to about 55%. He described further gross-margin improvement as an important component of the company’s value-creation strategy, particularly as innovative products account for a larger share of sales.
Teva has targeted a 30% operating margin by 2027, despite the anticipated loss of generic REVLIMID sales. Francis said the company is “well on track” to achieve that target, citing a changing portfolio mix and a cost-efficiency program expected to generate $700 million in savings after investment by the end of 2027.
While Francis said operating margin should rise beyond 2027, he did not provide a longer-term target. He said management is weighing whether to establish goals for 2030 or later, while balancing margin expansion against investment in the company’s product pipeline.
“Do not sacrifice the pipeline for short-term operating margin” is a message Francis said he has heard from investors. He said Teva intends to allocate capital only to projects expected to generate returns, rather than maintaining fixed R&D budgets or pursuing “pet projects.”
Pipeline and Portfolio Francis highlighted Teva’s pipeline of innovative medicines, including duvakitug, an anti-TL1A antibody being studied in inflammatory conditions; anti-IL-15 programs; long-acting olanzapine; ecopipam for Tourette syndrome; and UZEDY. He said Teva expects to have a product launch each year for the next five years, followed by launches approximately every 18 months thereafter.
He credited Teva’s internal antibody-engineering capabilities, including work conducted at its research facility in Sydney, for the company’s pipeline. Francis said the company is advancing a TSLP/IL-13 program into the clinic in the first quarter and expects data on its PD-1/IL-2 program by year-end.
On duvakitug, Francis said Teva believes its TL1A antibody has advantages in potency, specificity and low neutralizing antibodies compared with competing products. He said the company believes TL1A therapies could be used earlier in the treatment of inflammatory bowel disease because of their safety and tolerability profiles, though he cautioned that combination approaches and other treatment modalities will take time to develop.
Growth Brands and Upcoming Launches Francis said AUSTEDO continues to have substantial growth potential in tardive dyskinesia, where he estimated that 85% of patients remain untreated. Teva is seeking to improve patient titration, adherence and compliance, which he said can help patients reach more effective doses and remain on therapy. He reiterated confidence in a goal of more than $3 billion in peak annual sales for AUSTEDO.
He noted that AUSTEDO’s reported sales comparisons may be affected by inventory dynamics. Channel inventory built in the fourth quarter of the prior year is being drawn down, and wholesalers may further reduce inventory ahead of an Inflation Reduction Act-related discount. Francis said fourth-quarter sales could be down year over year, while prescription trends and milligram growth remain competitive.
Francis also pointed to AJOVY’s performance, saying the migraine treatment has been reinvigorated through more focused execution rather than significantly higher spending. He said AJOVY has been growing faster than its market and gaining share across regions, adding that management sees it as a potential billion-dollar brand.
For Teva’s long-acting olanzapine treatment, Francis said the opportunity stems from the large number of schizophrenia patients using oral olanzapine and the need for better treatment adherence. He said Teva estimates a $1.5 billion to $2 billion franchise opportunity for UZEDY and long-acting olanzapine, based partly on historical migration to long-acting treatments in related markets.
Francis said Teva expects modest revenue from the olanzapine launch initially, with revenue expected to begin building in the second half of the following year as Medicaid coverage expands. He said the company is prioritizing sustainable value and payer access rather than accepting discounts that it believes do not reflect a product’s value.
He also expressed optimism about ecopipam, Teva’s planned treatment for Tourette syndrome. Francis said approximately 100,000 children have Tourette syndrome, with roughly 50,000 receiving therapy, and said persistence on existing treatments is low. He said Teva expects to apply its commercial experience in neurology and central nervous system diseases to support the planned launch.
Generics and Capital Allocation Francis said Teva’s generics business, which had been declining before 2023, has returned to growth through improved product launches, manufacturing, supply chain execution and commercial discipline. He said the company has historically projected 1% to 2% annual growth for the business, but believes biosimilars could improve portfolio stability and margins over time.
Teva now has 15 biosimilars on the market and another 14 in its pipeline, Francis said.
On capital deployment, Francis said Teva has reached investment-grade ratings from all three major rating agencies a year earlier than expected. With debt reduction no longer the company’s first priority, he said Teva plans to continue investing in launches, pipeline development and business development opportunities. He said the company does not view a dividend as the best current use of capital and would consider share repurchases when management believes buying stock offers an attractive return.
About Teva Pharmaceutical Industries (NYSE:TEVA) Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva’s specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA Chief Executive Officer Richard Francis said the company has shifted from being viewed primarily as a generics manufacturer toward a biopharmaceutical company with a growing innovative medicines portfolio, while maintaining and expanding its generics operations.
Speaking with J.P. Morgan analyst Chris Schott, Francis said Teva’s “Pivot to Growth” strategy has centered on accelerating innovative products, stabilizing the generics business, advancing research and development, and maintaining discipline in capital allocation. He said the company’s innovative business grew 40% in the second quarter, while all of its marketed growth products delivered double-digit growth.
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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowFrancis said Teva’s innovative sales totaled about $1.2 billion at the end of 2022 and are now running at approximately $1 billion per quarter. He said the company expects to continue growing at a mid-single-digit rate after 2026, while the growing contribution from higher-margin innovative products could support gains in gross margin, operating income, earnings per share and cash flow.
Margins and Cost Savings Francis said Teva’s gross margin has risen from 48% when he became CEO to about 55%. He described further gross-margin improvement as an important component of the company’s value-creation strategy, particularly as innovative products account for a larger share of sales.
2 Generic Drug Stocks Ready to Surge in 2025Teva has targeted a 30% operating margin by 2027, despite the anticipated loss of generic REVLIMID sales. Francis said the company is “well on track” to achieve that target, citing a changing portfolio mix and a cost-efficiency program expected to generate $700 million in savings after investment by the end of 2027.
While Francis said operating margin should rise beyond 2027, he did not provide a longer-term target. He said management is weighing whether to establish goals for 2030 or later, while balancing margin expansion against investment in the company’s product pipeline.
“Do not sacrifice the pipeline for short-term operating margin” is a message Francis said he has heard from investors. He said Teva intends to allocate capital only to projects expected to generate returns, rather than maintaining fixed R&D budgets or pursuing “pet projects.”
Pipeline and Portfolio Francis highlighted Teva’s pipeline of innovative medicines, including duvakitug, an anti-TL1A antibody being studied in inflammatory conditions; anti-IL-15 programs; long-acting olanzapine; ecopipam for Tourette syndrome; and UZEDY. He said Teva expects to have a product launch each year for the next five years, followed by launches approximately every 18 months thereafter.
He credited Teva’s internal antibody-engineering capabilities, including work conducted at its research facility in Sydney, for the company’s pipeline. Francis said the company is advancing a TSLP/IL-13 program into the clinic in the first quarter and expects data on its PD-1/IL-2 program by year-end.
On duvakitug, Francis said Teva believes its TL1A antibody has advantages in potency, specificity and low neutralizing antibodies compared with competing products. He said the company believes TL1A therapies could be used earlier in the treatment of inflammatory bowel disease because of their safety and tolerability profiles, though he cautioned that combination approaches and other treatment modalities will take time to develop.
Growth Brands and Upcoming Launches Francis said AUSTEDO continues to have substantial growth potential in tardive dyskinesia, where he estimated that 85% of patients remain untreated. Teva is seeking to improve patient titration, adherence and compliance, which he said can help patients reach more effective doses and remain on therapy. He reiterated confidence in a goal of more than $3 billion in peak annual sales for AUSTEDO.
He noted that AUSTEDO’s reported sales comparisons may be affected by inventory dynamics. Channel inventory built in the fourth quarter of the prior year is being drawn down, and wholesalers may further reduce inventory ahead of an Inflation Reduction Act-related discount. Francis said fourth-quarter sales could be down year over year, while prescription trends and milligram growth remain competitive.
Francis also pointed to AJOVY’s performance, saying the migraine treatment has been reinvigorated through more focused execution rather than significantly higher spending. He said AJOVY has been growing faster than its market and gaining share across regions, adding that management sees it as a potential billion-dollar brand.
For Teva’s long-acting olanzapine treatment, Francis said the opportunity stems from the large number of schizophrenia patients using oral olanzapine and the need for better treatment adherence. He said Teva estimates a $1.5 billion to $2 billion franchise opportunity for UZEDY and long-acting olanzapine, based partly on historical migration to long-acting treatments in related markets.
Francis said Teva expects modest revenue from the olanzapine launch initially, with revenue expected to begin building in the second half of the following year as Medicaid coverage expands. He said the company is prioritizing sustainable value and payer access rather than accepting discounts that it believes do not reflect a product’s value.
He also expressed optimism about ecopipam, Teva’s planned treatment for Tourette syndrome. Francis said approximately 100,000 children have Tourette syndrome, with roughly 50,000 receiving therapy, and said persistence on existing treatments is low. He said Teva expects to apply its commercial experience in neurology and central nervous system diseases to support the planned launch.
Generics and Capital Allocation Francis said Teva’s generics business, which had been declining before 2023, has returned to growth through improved product launches, manufacturing, supply chain execution and commercial discipline. He said the company has historically projected 1% to 2% annual growth for the business, but believes biosimilars could improve portfolio stability and margins over time.
Teva now has 15 biosimilars on the market and another 14 in its pipeline, Francis said.
On capital deployment, Francis said Teva has reached investment-grade ratings from all three major rating agencies a year earlier than expected. With debt reduction no longer the company’s first priority, he said Teva plans to continue investing in launches, pipeline development and business development opportunities. He said the company does not view a dividend as the best current use of capital and would consider share repurchases when management believes buying stock offers an attractive return.
About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva's specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
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MONTPELLIER, France--(BUSINESS WIRE)--Medincell's partner Teva presented new data on investigational Olanzapine long-acting injectable (LAI) and UZEDY®, two treatments utilizing Medincell's proprietary BEPO® technology, licensed to Teva as SteadyTeq™. The findings were presented at Psych Congress 2026, held from September 15 to 19 in New Orleans, Louisiana. Teva presented new post hoc analyses from the Phase 3 SOLARIS trial evaluating its investigational once-monthly subcutaneous olanzapine LAI.
In a post hoc analysis of the open-label safety stage of the Phase 3 SOLARIS trial, more than half of participants receiving TEV-'749 achieved stabilization, few relapsed and more than one-fifth of participants receiving TEV-'749 for ≥ 6 months met criteria for remission Treatment switch analyses provide clinical insights into maintaining established therapeutic ranges of olanzapine when initiating TEV-'749 from existing regimens Ahead of the Q4 FDA anticipated approval decision, the growing body of science around TEV-'749 demonstrates Teva’s commitment to patient-centered innovation in neuroscience, including a differentiated long-acting injectable franchise PARSIPPANY, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of new olanzapine LAI (TEV-'749) post hoc data from the pivotal SOLARIS Phase 3 trial as well as analyses supporting treatment switch strategies. The SOLARIS data highlighted the acute and long-term durability, efficacy and safety of TEV-'749 as a once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults. The findings were presented at Psych Congress, held September 15 – 19, 2026, in New Orleans, LA.
“These findings further validate the long-term clinical profile of TEV-'749 and its potential to be a once-monthly subcutaneous injectable olanzapine treatment that can help support stabilization for people living with schizophrenia,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “For those currently taking daily oral olanzapine and may be interested in switching to an LAI, these data suggest that TEV-'749 can support long-term symptom control, helping to potentially fill an unmet need for this patient community.”
Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment.1 However, daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse.2
Long-Term Data Show High Stabilization and Low Rates of Relapse
In a post hoc analysis of the long-term treatment open-label period of the Phase 3 SOLARIS trial, more than half of all participants receiving TEV-'749 achieved stabilization, more than one-fifth of long-term trial participants met criteria for remission (defined as maintaining a Positive and Negative Syndrome Scale [PANSS] item score of 3 or lower for at least six consecutive months across eight specific remission items), and few that had reached stabilization relapsed.
Among 411 participants, 231 (56% [61%, 54%, and 54% with 318-, 425-, and 531-mg dose groups, respectively]) achieved stabilizationAmong 231 participants who achieved stabilization, only 10 (4% [6%, 1%, and 5%]) experienced relapseAmong 183 participants who were treated with TEV-'749 for six or more months, 39 (21% [26%, 13%, and 26%]) achieved remission “These TEV-'749 data are compelling because the vast majority of patients who start or respond well to olanzapine are treated with a daily oral pill of olanzapine,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “We know that long-acting injectable treatment options may support stability and reduce risk of relapse, and TEV-'749 has the potential to offer many of these individuals the efficacy of olanzapine in a once-monthly formulation.”
Data Support Direct Switching from Daily Pills or Short-Acting Injections to Once-Monthly TEV-'749
In separate analyses simulating potential switching scenarios in the inpatient, initiation of TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine resulted in predictable olanzapine exposures that remained within established oral therapeutic ranges. The findings offer clinical insights into how healthcare providers may switch patients to TEV-'749 who are currently taking other olanzapine formulations.
Finally, an analysis of metabolic outcomes found that the metabolic profile of TEV-'749 was consistent with daily oral olanzapine formulations, with no clear dose-dependent pattern observed. These data add to the broader safety and tolerability findings from the SOLARIS program.
Below is the full set of olanzapine LAI (TEV-'749) posters being presented by Teva at Psych Congress 2026:
(De novo) Durability of Response With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Schizophrenia: Post Hoc Analysis of the Phase 3 SOLARIS Trial(De novo) Population Pharmacokinetic Simulations of Inpatient Switching From Oral or Short-Acting Intramuscular Olanzapine to TV-44749(De novo) Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults With Schizophrenia: Efficacy Results From the Phase 3 SOLARIS Trial(De novo) Characterization of the Body Weight and Metabolic Profile of Subcutaneous Long-Acting Injectable Olanzapine (TV-44749): Results From the Phase 3 SOLARIS Trial(Modified encore) Joint Population Pharmacokinetic Model of Oral, Intramuscular, and Subcutaneous (TV-44749) Olanzapine to Support TV-44749 Dosing and Switching Strategies TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.
TEV-'749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.
A PDUFA decision from the FDA is expected for TEV-'749 in Q4 2026. In the EU, the European Medicines Agency accepted the Marketing Authorization Application for TEV-'749 in May 2026.
About Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS)
SOLARIS was a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.1 For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (low, medium or high dose) or placebo in a 1:1:1:1 ratio.1 For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI treatment groups, while patients who completed period one on active olanzapine LAI remained on their established dose strength.1 The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.1 The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI in adult patients with schizophrenia, as measured by PANSS.1 A key secondary objective was to further evaluate the efficacy of olanzapine LAI based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP.1 A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI in adult patients with schizophrenia.1
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.2 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.2 million people in the U.S. are currently diagnosed with the condition.3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.4 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.4 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.2,3,4,5,6,7
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adult patients diagnosed with schizophrenia and to obtain regulatory FDA approval; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Data on file. [CSR/SOLARIS]. West Chester, PA: Teva Neuroscience, Inc.Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615. Teva Media Inquiries: [email protected]
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.
New findings show favorable treatment continuity for UZEDY compared to other long-acting injectables in schizophrenia, as well as oral antipsychotics in bipolar I disorder (BD-I)The new real-world data also show that UZEDY decreased emergency room visits and hospitalizations, lowering overall healthcare resource utilization and delivering over $1,000 per patient per month in direct cost savingsThe breadth of clinical evidence presented highlights Teva’s ongoing commitment to evaluating how therapies perform in patients’ everyday lives to assist in improving routine care and reducing the burden of severe mental illness PARSIPPANY, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new real-world data evaluating treatment continuity, healthcare resource utilization (HCRU) and clinical outcomes among adults with schizophrenia and bipolar I disorder (BD-I) treated with UZEDY (risperidone) extended-release injectable suspension. The results demonstrate how UZEDY helps patients with schizophrenia remain on treatment longer while reducing emergency care and healthcare costs compared with other treatment options. The new findings were presented at Psych Congress, held September 15 – 19, 2026, in New Orleans, LA.
“We cannot accept psychiatric emergencies and hospitalizations as an inevitable part of living with schizophrenia and bipolar I disorder,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “These findings show that when we provide a treatment option like UZEDY that helps patients stay on track, we can meaningfully cut emergency room visits and help people maintain stability in their everyday lives. Delivering measurable impact for patients and healthcare systems is what drives everything we do at Teva.”
Schizophrenia Data Highlights
The two schizophrenia abstracts featured at Psych Congress highlight significant clinical and economic advantages in real-world settings:
Lower Emergency Care and Costs vs. Paliperidone Palmitate Once-Monthly (PP1m): In a matched cohort of 1,166 patients (583 per group), fewer patients receiving once-monthly UZEDY had an emergency department (ED) visit compared to PP1m (22.0% vs. 27.8%). Overall, UZEDY patients had a 40% lower all-cause ED visit rate and a numerically lower proportion of inpatient hospitalizations (11.1% vs. 14.8%). Estimated mean monthly direct healthcare costs were significantly lower for UZEDY ($4,688.10 vs. $5,724.80), delivering an adjusted mean monthly savings of $1,036.70 per patient.Superior Adherence and Persistence vs. Other Long-Acting Injectable Antipsychotics: Matched cohorts compared once-monthly UZEDY to risperidone microspheres every-2-weeks, aripiprazole once-monthly and haloperidol decanoate once-monthly. The greatest differences were observed against risperidone microspheres, where UZEDY patients achieved 3.6x higher odds of adherence (OR: 3.6), an 80% lower likelihood of discontinuation (OR: 0.2) and lower rates of ED visits and hospitalizations. UZEDY patients also had lower ED visit rates versus haloperidol decanoate once-monthly, while outcomes versus aripiprazole once-monthly were generally comparable. “As clinicians, it is frustrating to watch patients with schizophrenia struggle through cycles of relapse and end up back in the emergency room,” said John M. Kane, MD, Professor of Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “We need to think differently about how we use long-acting injectables. This observational data shows that patients receiving UZEDY had greater treatment continuity and fewer emergency department visits, reinforcing the potential of this approach to help patients stay stable while reducing pressure on an already strained healthcare system.”
BD-I Data Highlights
Teva also presented new study findings evaluating outcomes in patients living with BD-I who switched from oral antipsychotics to UZEDY:
Real-World Effectiveness of Switching From Oral Antipsychotics to UZEDY in BD-I: A retrospective chart review of 358 matched patients (179 per group) evaluated patient outcomes after transitioning from oral antipsychotics to either UZEDY or another oral antipsychotic. Patients who switched to UZEDY experienced significantly less treatment failure (47% vs. 63%) compared to those switched to another oral antipsychotic. Patients receiving UZEDY were also more likely to stay on treatment longer without experiencing BD-I/mania-related hospitalizations, ED visits or discontinuation due to inadequate effectiveness. As the treatment landscape for severe mental illness continues to evolve, real-world evidence remains essential in guiding clinical decisions that optimize patient outcomes and healthcare resources. These findings further validate UZEDY as an innovative, effective and economically beneficial treatment option for patients navigating the complex, daily challenges of schizophrenia and BD-I.
About UZEDY
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. In clinical trials, UZEDY significantly delayed time to relapse in adults with schizophrenia.1,2 UZEDY administers risperidone through copolymer technology under license from Medincell that allows for rapid absorption and sustained release after subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.
APPROVED USE
UZEDY (risperidone) extended-release injectable suspension is a prescription medicine used in adults
for the treatment of schizophreniafor the maintenance treatment of bipolar I disorder as monotherapy or as adjunctive therapy to lithium or valproate IMPORTANT SAFETY INFORMATION
What is the most important information I should know about UZEDY?
UZEDY can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). UZEDY is not approved for use in patients with dementia-related psychosis.
Do not receive UZEDY if you are allergic to risperidone, paliperidone, or any of its components.
UZEDY may cause serious side effects, including:
Stroke in elderly people (cerebrovascular problems) that can lead to death.Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, severe muscle stiffness, confusion, sweating, irregular heartbeat, fast heart rate, or changes in your blood pressure.Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving UZEDY. Tardive dyskinesia may also start after you stop receiving UZEDY.Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk for diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with UZEDY. Call your healthcare provider if you have symptoms of high blood sugar including: feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.High levels of prolactin in your blood. UZEDY may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, decreased fertility in women, leakage of milk from the breasts, development of breasts in men, or problems with erection.Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.Falls. Antipsychotic medicines like UZEDY may cause drowsiness or dizziness when you are standing, which could increase your risk for falls and related injuries.Low white blood cell count.Problems thinking clearly and moving your body. Do not drive, operate machinery, or do other dangerous activities until you know how UZEDY affects you.Seizures (convulsions).Difficulty swallowing that can cause food or liquid to get into your lungs.Prolonged or painful erection lasting more than 4 hours. Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.Problems with control of your body temperature (too high or too low). Avoid getting overheated or dehydrated. The most common side effects of risperidone in patients with
Schizophrenia included slow movements, stiffness, shaking, restlessness, abnormal muscle contractions or movements, drowsiness, dizziness, anxiety, blurred vision, nausea, vomiting, indigestion, diarrhea, increased saliva, constipation, dry mouth, increased appetite, weight gain, tiredness, rash, and common cold symptomsBipolar disorder were weight increased (5% in monotherapy trial) and slow movements, stiffness, shaking (≥10% in adjunctive therapy trial).Injection site reactions including a lump or itching were reported with UZEDY. These are not all the possible side effects of UZEDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.
Do not drink alcohol during treatment with UZEDY.
Before receiving UZEDY, tell your healthcare provider about all your medical conditions, including if you:
have had Neuroleptic Malignant Syndrome.have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia).have diabetes or have a family history of diabetes.have had dizziness or fainting or are being treated for high blood pressure.have had a low white blood cell count.have or have had seizures or epilepsy.are pregnant or plan to become pregnant during treatment with UZEDY. It is not known if UZEDY will harm your unborn baby. Use of UZEDY during the third trimester of pregnancy may cause side effects in the newborn infant, including agitation, abnormal muscle tone, tremor, drowsiness, difficulty feeding, and difficulty breathing. Seek medical attention if you notice these signs. If you become pregnant during treatment with UZEDY, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics, or call 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.are breastfeeding or plan to breastfeed. If you are receiving UZEDY and are breastfeeding, monitor your infant for sleepiness, inadequate weight gain, jitteriness, tremors, and abnormal muscle movements. Seek medical care if you notice these signs.have or have had kidney or liver problems. Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. UZEDY and other medicines may affect each other.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For more information about UZEDY, see the full Prescribing Information including Boxed WARNING, or talk to your healthcare provider.
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.3 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.3,4,5 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.2 million people in the U.S. are currently diagnosed with the condition.4,5,6 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.3 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.5 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.7,8,9 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.3,4,5,7,8,9
About Bipolar I Disorder
Bipolar I Disorder (BD-I) is a serious mental health condition defined by episodes of mania—periods of abnormally elevated or irritable mood with increased energy and activity—and often episodes of depression. These episodes can cause significant disruptions in thinking, behavior, and daily functioning. It is challenging to diagnose and is often accompanied by other psychiatric comorbidities. BD-I is associated with poor long-term outcomes and a substantial increase in mortality compared to the general population from both suicide and cardiovascular disease. An estimated 1% or 3,400,000+ of U.S. adults will develop BD-I in their lifetime.10
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize UZEDY (risperidone) for the treatment of schizophrenia and bipolar I disorder; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
References:
UZEDY® (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.Data on file. [CSR/RISE]. West Chester, PA: Teva Neuroscience, Inc.Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed March 2026.Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.DRG / Clarivate (Nov 2025 Market Forecast Assumptions-Schizophrenia)Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615. Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2007;64(5):543–552. doi:10.1001/archpsyc.64.5.543 Teva Media Inquiries: [email protected]
New data revealed that healthcare providers prioritize drowsiness risk, duration of available data demonstrating long-term response and drug-drug interaction profile when selecting a treatment for tardive dyskinesia (TD) in patients aged ≥55 yearsAcross all four patient profiles, AUSTEDO® (deutetrabenazine) was most closely related to the attributes most valued by healthcare providersThese findings from Teva detail specific healthcare provider preferences around tolerability and efficacy, while reinforcing the importance of treatment for TD
PARSIPPANY, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data from a discrete choice experiment highlighting preferred healthcare provider (HCP) treatment attributes when selecting a VMAT2 inhibitor for the treatment of TD in older patients (aged ≥55 years). The new findings were presented at Psych Congress, held September 15 – 19, 2026, in New Orleans, LA.
“At the heart of every treatment decision for tardive dyskinesia is a patient looking for improvement in their burdensome physical symptoms, and the impact those symptoms have on daily life,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “At Teva, we’re committed to developing therapies and delivering clinical solutions for TD communities that help eliminate challenges to treat. Offering a treatment like AUSTEDO, with attributes healthcare providers value, is essential to delivering effective, patient-centered care.”
HCP Preference Driven by Tolerability and Efficacy
In a discrete choice experiment (DCE), 489 HCPs representing a variety of specialties prioritized key attributes driving their TD treatment preferences for patients aged ≥55 years. Participants prioritized somnolence risk and short-term Abnormal Involuntary Movement Scale (AIMS) improvement, followed by dose formulation, drug-drug interaction risk and demonstrated long-term response, as the key drivers for VMAT2 inhibitor selection across four different patient profiles. Applying these preferences to the available VMAT2 inhibitor treatment options, AUSTEDO® had the highest predicted choice probability across all patient profiles; this preference was mainly driven by somnolence risk, duration of available data demonstrating long-term response, and drug-drug interaction.
Data from the DCE revealed:
HCPs identified somnolence (drowsiness) risk (accounting for 26.8% - 36.2% of decision-making weight) and short-term symptom improvement (24.4% - 29.5%) as their top priorities when evaluating VMAT2 inhibitors for TD treatment, followed by dose formulation (16.7% - 20.2%) and drug-drug interaction risk (14.4% - 17.3%).HCPs distinctly adapt their prescribing criteria based on patient presentation. The risk of somnolence was prioritized higher for outpatients (ex-long-term care) (up to 36.2% decision weight) than for those being treated in long-term care settings (up to 29.5%).Driven directly by these clinical priorities, HCPs were predicted to prefer AUSTEDO across all four patient profiles.
“Selecting a treatment for those living with tardive dyskinesia involves weighing a range of factors, from symptom improvement and tolerability to practical considerations,” said Gustavo Alva, MD, board-certified psychiatrist. “By shedding light on the attributes healthcare professionals prioritize, these findings may support more informed, individualized treatment discussions and provide healthcare providers with greater confidence in selecting a TD treatment that addresses immediate patient needs and supports long-term treatment success.”
Persistent Burden of Untreated TD
Also presented at Psych Congress, a new interim analysis from the IMPACT-TD Registry examined changes in TD severity and quality of life for individuals with probable TD who remained untreated with any VMAT2 inhibitor for 24 months. TD burden persisted, with approximately 89%–96% of participants experiencing at least a mild global impact of TD, including 60%–74% who experienced moderate-to-severe impact. Most patients (55%–69%) reported stable or worsening TD severity relative to baseline, with no evidence of spontaneous resolution. Depression and anxiety scores also fluctuated over the two-year period without sustained improvement.
Together, these findings reinforce the critical need for proactive, effective management of TD. By understanding the enduring consequences of untreated TD in the real-world, as well as the specific treatment attributes HCPs value most, like early symptom control and tolerability, Teva remains deeply committed to advancing care, empowering HCPs and driving long-term adherence for patients managing this complex condition.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3
About AUSTEDO XR® Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.
INDICATIONS AND USAGE
AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.
Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.
Please see accompanying full Prescribing Information, including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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References:
Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive Dyskinesia Prevalence in the Period of Second-Generation Antipsychotic Use: A Meta-Analysis. J Clin Psychiatry. 2017;78(3):e264-e278. doi: 10.4088/JCP.16r10832.Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed August 19, 2026.
Teva Media Inquiries: [email protected]
Teva Pharmaceutical Industries (NYSE:TEVA) said its “Pivot to Growth” strategy has moved into its second phase, with management pointing to momentum in branded medicines, a stabilized generics business, an expanding biosimilars portfolio and a strengthened balance sheet.
Speaking at a Morgan Stanley event, President and Chief Executive Officer Richard Francis said the company began the strategy in 2023 with goals to return to growth, accelerate growth and maintain growth. The strategy is built around four pillars: delivering on its growth engine, stepping up innovation, creating a generics powerhouse, and focusing the business and capital allocation.
Francis said Teva has sought to transform from a pure-play generics company into a biopharmaceutical company, supported by growth products including AUSTEDO, AJOVY and UZEDY. He also highlighted Teva’s first deal with Amylyx as aligned with its central nervous system strategy. The company has also reduced debt and achieved investment-grade ratings from all three major ratings agencies more than a year earlier than it had projected, according to Francis. He said Teva completed an oversubscribed refinancing in the prior week and had converted ADS shares into ordinary shares, a move he said could broaden investor access to the company.
AUSTEDO and AJOVY Growth Outlook Francis reiterated his confidence that AUSTEDO can generate more than $3 billion in sales over time. Teva had previously targeted $2.5 billion in AUSTEDO sales, and Francis said the company now appears positioned to reach that milestone a year ahead of its earlier timetable. He did not provide 2027 guidance, saying the company would offer further details after reviewing third- and fourth-quarter data.
He cited a large untreated population of patients with tardive dyskinesia and Teva’s ability to identify patients, move them onto therapy, optimize dosing and support adherence as drivers of the product’s opportunity. Francis acknowledged that the market is competitive, but said Teva has focused on resource allocation and commercial execution rather than commenting on competitors.
AJOVY has also outperformed the injectable CGRP market, according to Francis. He said Teva’s prior ambition was for the migraine treatment to exceed $1 billion in sales, a threshold it is approaching faster than expected. Management may issue updated AJOVY guidance, he said, while cautioning that the duration of its above-market growth remains to be seen.
Francis attributed performance across AJOVY, AUSTEDO and UZEDY to the company’s commercial capabilities and operational focus across regions.
UZEDY, Olanzapine and Generics On UZEDY, Teva’s long-acting injectable risperidone treatment, Francis said the product has gained traction in a competitive market and that the company is now the leading long-acting injectable in risperidone. He said Teva has doubled the risperidone long-acting injectable market during its time in the category.
Teva sees a potential opportunity to launch its long-acting injectable olanzapine product outside the U.S., although Francis said pricing will be an important consideration. The company has not included an international UZEDY contribution in its forecast, he said.
Combined, Teva has projected UZEDY and olanzapine could generate $1.5 billion to $2 billion. Francis said upside could depend on long-acting injectable penetration, U.S. Medicare access and European launches at appropriate pricing.
For olanzapine in the U.S., Francis said the initial focus will be on sampling and securing hospital formulary access. He identified state-by-state Medicaid access as the principal near-term limiting factor, estimating that roughly 85% of the Medicaid market could be accessible after 12 months. He said Teva does not expect to seek Medicare access through discounts that it considers inconsistent with the product’s value.
In generics, Francis said the business has moved from years of decline to three-year compound annual growth, driven by launches, manufacturing improvements, supply reliability and commercial execution. He said the next major portfolio shift will be a growing contribution from biosimilars.
Teva has 11 biosimilars in the market, Francis said. The company expects to add roughly nine more by the end of the decade. Its broader biosimilars portfolio includes approximately 26 to 29 products, he said. Francis said Teva was on track to exceed its $800 million biosimilars target for 2027 a year early, supported by opportunities in both the U.S. and Europe.
Pipeline and Business Development Eric Hughes, Teva’s executive vice president of global research and development and chief medical officer, discussed duvakitug, the company’s TL1A therapy being developed with Sanofi for ulcerative colitis and Crohn’s disease. Hughes said phase 2 results showed what he described as the highest results reported for the class, while maintenance data released this year was competitive across both diseases.
Teva believes duvakitug could be within an 18-month window of competitors in ulcerative colitis, Hughes said, while characterizing its Crohn’s disease program as being in the middle of the competitive group. He added that eventual outcomes will depend on late-stage data.
Hughes also cited development work for TL1A in hidradenitis suppurativa, saying the disease has substantial unmet need and that the mechanism could address multiple inflammatory and fibrotic pathways.
For ecopipam, Teva filed a new drug application in June and has received priority review, according to Hughes. The company expects a potential launch in the first half of 2027. Hughes described ecopipam as a first-in-class D1 antagonist for Tourette’s disease and said its studies showed about a 30% effect versus placebo, with a safety profile that did not show the side effects associated with D2 antagonists.
Looking ahead, Francis said Teva is interested in selective business-development opportunities in CNS, immunology, respiratory medicine and rare diseases. He said the company does not face a “desperate need” to make acquisitions, but may pursue thoughtful in-licensing or smaller transactions that can provide additional assets for its development and commercial organizations.
About Teva Pharmaceutical Industries (NYSE:TEVA) Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva’s specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
Takeda Pharmaceutical (NYSE:TAK – Get Free Report) and Teva Pharmaceutical Industries (NYSE:TEVA – Get Free Report) are both healthcare companies, but which is the superior business? We will compare the two companies based on the strength of their valuation, dividends, analyst recommendations, risk, profitability, institutional ownership and earnings.
Volatility and Risk Takeda Pharmaceutical has a beta of -0.07, suggesting that its share price is 107% less volatile than the S&P 500. Comparatively, Teva Pharmaceutical Industries has a beta of 0.87, suggesting that its share price is 13% less volatile than the S&P 500.
Earnings and Valuation This table compares Takeda Pharmaceutical and Teva Pharmaceutical Industries”s revenue, earnings per share (EPS) and valuation.
Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Takeda Pharmaceutical $28.32 billion 2.12 -$1.01 billion $0.34 55.03 Teva Pharmaceutical Industries $17.26 billion 2.64 $1.41 billion $0.60 65.26 Teva Pharmaceutical Industries has lower revenue, but higher earnings than Takeda Pharmaceutical. Takeda Pharmaceutical is trading at a lower price-to-earnings ratio than Teva Pharmaceutical Industries, indicating that it is currently the more affordable of the two stocks.
Analyst Ratings This is a breakdown of current recommendations and price targets for Takeda Pharmaceutical and Teva Pharmaceutical Industries, as reported by MarketBeat.com.
Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Takeda Pharmaceutical 0 1 2 1 3.00 Teva Pharmaceutical Industries 0 1 10 0 2.91 Teva Pharmaceutical Industries has a consensus target price of $43.10, suggesting a potential upside of 10.08%. Given Teva Pharmaceutical Industries’ higher probable upside, analysts clearly believe Teva Pharmaceutical Industries is more favorable than Takeda Pharmaceutical.
Profitability This table compares Takeda Pharmaceutical and Teva Pharmaceutical Industries’ net margins, return on equity and return on assets.
Net Margins Return on Equity Return on Assets Takeda Pharmaceutical 3.80% 10.95% 5.34% Teva Pharmaceutical Industries 4.08% 32.64% 6.34% Insider and Institutional Ownership 9.2% of Takeda Pharmaceutical shares are owned by institutional investors. Comparatively, 54.0% of Teva Pharmaceutical Industries shares are owned by institutional investors. 0.0% of Takeda Pharmaceutical shares are owned by insiders. Comparatively, 0.5% of Teva Pharmaceutical Industries shares are owned by insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a stock will outperform the market over the long term.
Summary Teva Pharmaceutical Industries beats Takeda Pharmaceutical on 12 of the 15 factors compared between the two stocks.
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Takeda Pharmaceutical Company Limited engages in the research, development, manufacture, marketing, and out-licensing of pharmaceutical products in Japan and internationally. It offers pharmaceutical products in the areas of gastroenterology, rare diseases, plasma derived therapies, immunology, oncology, and neuroscience. The company provides its products under the Entyvio, Gattex/Revestive, Takecab/Vocinti, Alofisel, Dexilant, Pantoloc/Controloc, Adynovate/Adynovi, Feiba, Recombinate, Hemofil/Immunate/Immunine, Takhzyro, Livtencity, Elaprase, Replagal, Advate, Flexbumin, Vpriv, Gammagard Liquid/Kiovig, Hyqvia, Cuvitru, Exkivity, Ninlaro, Velcade, Azilva-F, Lotriga, Iclusig, Leuplin/Enantone, Adcetris, vyvanse/elvanse, Trintellix, and Alunbrig brands. It has in-license agreement with BioMarin, Luxna Biotech, GlaxoSmithKline, Halozyme, and Kamada; collaboration with Neurocrine Biosciences, Inc., Seagen Inc., Anima Biotech, Denali Therapeutics, KSQ Therapeutics, Noile-Immune Biotech, Center for iPS Cell Research Application, Kyoto University (CiRA), and Charles River Laboratories; licensing agreement with Mirum Pharmaceuticals and Twist Bioscience, UCSD/Fortis Advisors, PeptiDream, MD Anderson Cancer Center, Teva Pharmaceutical Industries, and Xenetic Biosciences; collaboration and licensing agreement with Arrowhead Pharmaceuticals Inc., Engitix, Genevant Sciences Corporation, Sosei Heptares, Zedira/Dr. Falk Pharma, Exelixis, Inc., GlaxoSmithKline, Heidelberg Pharma, HUTCHMED, Presage Biosciences, Codexis, Inc., Ensoma, Envozyne, KM Biologics, and Selecta BioScience, and Ovid Therapeutics Inc.; and collaboration with ZEDIRA GmbH and Dr. Falk Pharma GmbH. It has research collaboration and licensing agreement with Crescendo Biologics, Code Bio, Immusoft, Poseida Therapeutics, and Selecta Biosciences. The company was founded in 1781 and is headquartered in Tokyo, Japan.
About Teva Pharmaceutical Industries (Get Free Report)
Teva Pharmaceutical Industries Limited develops, manufactures, markets, and distributes generic medicines, specialty medicines, and biopharmaceutical products in North America, Europe, Israel, and internationally. It offers generic medicines in various dosage forms, such as tablets, capsules, injectables, inhalants, liquids, transdermal patches, ointments, and creams; sterile products, hormones, high-potency drugs, and cytotoxic substances in parenteral and solid dosage forms; and generic products with medical devices and combination products. The company focuses on the central nervous system (CNS), respiratory, and oncology areas. It provides active pharmaceutical ingredients, as well as contract manufacturing services; and operates an out-licensing platform that offers a portfolio of products to other pharmaceutical companies. The company also offers BENDEKA and TREANDA injections for the treatment of chronic lymphocytic leukemia and indolent b-cell non-hodgkin’s lymphoma; GRANIX; TRISENOX; LONQUEX; and TEVAGRASTIM/RATIOGRASTIM. In addition, it provides COPAXONE for the treatment of relapsing forms of multiple sclerosis; AJOVY for the preventive treatment of migraine in adults; AUSTEDO for the treatment of neurodegenerative and movement disorders associated with Huntington’s disease and tardive dyskinesia; UZEDY for the treatment of schizophrenia; ProAir RespiClick inhalation powder; QVAR for treatment for asthma; BRALTUS, a long-acting muscarinic antagonist; CINQAIR/CINQAERO injection; DuoResp Spiromax, an inhaled corticosteroid and long-acting beta-agonist bronchodilator; and AirDuo RespiClick fluticasone propionate and salmeterol inhalation powder. The company offers its OTC products under SUDOCREM, NasenDuo, DICLOX FORTE, OLFEN Max, and FLEGAMINA brand names. It has collaboration agreements with MedinCell; Sanofi; Alvotech; and Biolojic Design Ltd., as well as license agreement with MODAG GmbH. The company was founded in 1901 and is based in Tel Aviv, Israel.
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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) had a busy week that included a major debt refinancing, a milestone shift in how its shares trade on the NYSE and analyst activity.
Teva stock is trading near recent highs. Where is TEVA stock headed? Multi-Tranche Senior Notes Offering to Redeem Existing DebtOn Sept. 10, Teva announced it successfully priced approximately $4.9 billion (equivalent) of senior notes across five tranches denominated in euros and U.S. dollars, with maturities ranging from 2032 to 2037. The offering, expected to settle on or about September 16, is intended to fund the redemption of several existing note series, including its 6.750% Senior Notes due 2028 and multiple sustainability-linked notes due between 2027 and 2031. The new notes will be unsecured senior obligations of the issuers and unconditionally guaranteed by Teva.
The NYSE Direct ListingOn September 14, Teva announced its ordinary shares began trading directly on the New York Stock Exchange, completing the company’s planned transition away from its American Depositary Shares program. Shares continue to trade under the ticker “TEVA” on both the NYSE and the Tel Aviv Stock Exchange.
“Today marks another meaningful milestone in Teva’s transformation,” said Richard Francis, President and CEO of Teva. “The trading of our ordinary shares on the NYSE is expected to broaden investor access to our shares and reflects the momentum we are building through our Pivot to Growth strategy.”
Teva said the move follows its return to investment-grade credit ratings from all three major ratings agencies, and comes as the company’s three flagship innovative brands — Austedo, Ajovy, and Uzedy — have grown collectively by more than 40% year-over-year, with expected 2026 revenues of approximately $3.7 billion.
Analyst Consensus & Recent Actions The stock carries a Buy rating with an average price forecast of $43.71. Recent analyst activity include:
Leerink Partners: Initiated with Outperform (Target $45.00) (Sept. 9) Read Next
TEVA Price Action: At the time of publication, Teva shares are trading 0.77% higher at $39.02, according to data from Benzinga Pro.
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MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA CEO Richard Francis said the company has progressed from the initial phase of its “Pivot to Growth” plan into its next stage, citing momentum in branded medicines, innovation, generics and biosimilars, as well as improved financial flexibility.
Speaking at the Morgan Stanley Global Healthcare Conference, Francis said the strategy, launched in 2023, is centered on delivering growth from existing products, increasing innovation, building a generics powerhouse and focusing the business and capital allocation. He said Teva’s goal of evolving beyond a pure-play generics manufacturer into a biopharmaceutical company has become increasingly credible over the past three-and-a-half years.
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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowFrancis also highlighted the company’s debt reduction and recent return to investment-grade ratings from all three major rating agencies. Teva completed a refinancing last week that was “hugely oversubscribed,” he said, adding that the company achieved investment-grade status more than a year ahead of its stated target. Teva also converted ADS shares into ordinary shares, which Francis said would expand investor access to the company.
Tariffs and U.S. Manufacturing Addressing potential U.S. tariffs on imported generic drugs, Francis said Teva’s domestic manufacturing presence could provide an advantage, though he cautioned that the policy environment remains dynamic. He said Teva has the largest generic manufacturing footprint in the U.S. and has worked with the administration on matters involving the Department of Health and Human Services, the Inflation Reduction Act and a potential agreement referenced at the White House.
2 Generic Drug Stocks Ready to Surge in 2025Francis said Teva generates close to $40 billion in annual savings for the U.S. and believes the company has a meaningful voice in policy discussions. He added that the company’s growing biosimilars portfolio could help it navigate a more challenging market environment.
Branded Medicines Growth Francis reiterated that Teva’s AUSTEDO franchise is expected to generate more than $3 billion in sales over time. He did not provide 2027 revenue guidance but said the company appears positioned to reach its previously stated $2.5 billion target a year early based on the midpoint of its current guidance.
He attributed the opportunity to a large untreated population in tardive dyskinesia and to Teva’s improving ability to identify patients, initiate treatment, optimize dosing and support adherence. Francis acknowledged that the market is competitive, including competition from Neurocrine Biosciences’ INGREZZA, but said Teva remains focused on execution and disciplined resource allocation.
AJOVY has also exceeded Teva’s expectations, Francis said. The migraine treatment has been growing faster than its injectable CGRP market and gaining share, according to the CEO. Teva may need to issue new guidance for AJOVY as it approaches its $1 billion target more quickly than anticipated, he said.
For UZEDY, Teva’s long-acting risperidone treatment for schizophrenia, Francis said the company has benefited from a product profile that enables subcutaneous administration and can reach therapeutic doses within eight to 24 hours without concomitant adjunctive therapy. He said UZEDY is now the leading long-acting injectable risperidone product and that Teva has doubled that market since entering it.
Teva expects olanzapine, another long-acting injectable candidate, to have a clearer path for launches outside the U.S. than UZEDY, subject to pricing considerations. Francis said Teva has not included international UZEDY revenue in its forecasts. Together, UZEDY and olanzapine are projected by the company to generate $1.5 billion to $2 billion cumulatively.
Francis said the pace of olanzapine uptake will depend in part on state-by-state Medicaid access. Teva expects Medicaid coverage to reach approximately 85% of the market after 12 months, while the company does not expect to pursue Medicare access initially if doing so would require discounts that it views as inconsistent with the product’s value.
Generics and Biosimilars Francis said Teva’s generics business has shifted from several years of decline to growth over the past three years, supported by launches, manufacturing improvements, supply reliability and changes to its go-to-market approach. The next major change, he said, is an expanding biosimilars portfolio.
Teva currently has 11 biosimilars on the market and expects to add roughly nine more by the end of the decade, with 26 to 29 products in its broader portfolio, Francis said. He highlighted performance from products including Semglee and EPYSQLI and said Teva expects to exceed its target of $800 million in biosimilar revenue by the end of 2027 a year early.
He said Europe represents an additional opportunity as Teva expands biosimilar launches across different market structures, while the company sees opportunity in the complexity of the U.S. market.
Pipeline and Business Development Eric Hughes, Teva’s head of research and development, said the company’s TL1A candidate duvakitug has produced competitive Phase II and maintenance data in ulcerative colitis and Crohn’s disease. Teva and partner Sanofi are advancing Phase III programs, with Hughes saying Teva believes its ulcerative colitis timeline falls within an 18-month window of competitors.
Hughes also discussed TL1A development in hidradenitis suppurativa, citing the disease’s inflammatory and fibrotic components. He said Teva sees potential for the mechanism because it affects multiple cytokine pathways.
For ecopipam, Teva submitted a new drug application in June and has received priority review, Hughes said. The company expects a potential launch in the first half of 2027. Hughes described ecopipam as a first-in-class D1 antagonist for Tourette syndrome and said its studies showed efficacy alongside a safety profile that did not exhibit the side effects associated with D2 antagonists.
Francis said Teva does not have an urgent need for acquisitions but will consider selective business-development opportunities, particularly in central nervous system therapies, immunology, respiratory diseases and rare diseases. He said the company has five innovative launches planned over five years and expects additional opportunities from multiple indications for assets including duvakitug and its IL-15 program.
About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva's specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Teva Pharmaceutical Industries Limited (TEVA) Morgan Stanley 24th Annual Global Healthcare Conference September 14, 2026 8:30 AM EDT
Company Participants
Richard Francis - President, CEO & Director
Eric Hughes - Executive VP of Global R&D and Chief Medical Officer
Conference Call Participants
Adithya Venkat - Morgan Stanley, Research Division
Presentation
Unknown Analyst
Good morning, everyone. Thank you for joining this session of the Morgan Stanley Global Healthcare Conference. For those of you who don't know me, I'm [ Theresa Capilla ], European pharma research analyst here at Morgan Stanley, and I'm joined by my colleague, Adithya Venkat at MS.
And I'm very pleased to have Richard Francis and Eric Hughes here today, the CEO and Head of R&D of Teva. But thank you very much for joining us.
Richard Francis
President, CEO & Director
Thank you for having us.
Unknown Analyst
So before we get started, please note that this presentation is for Morgan Stanley institutional clients and employees.
For all important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your MS sales rep.
And I apologize for how many times I'm going to say that over the next 30 days. So perhaps we get started, Richard, before we go into detail, perhaps you could start with introductory comments as to where we are in the Teva story today, progress on the Pivot to Growth strategy and the outlook from here.
Richard Francis
President, CEO & Director
Okay. I'll try and be brief because I could spend the whole time talking about that. So where we are in the story, to answer that first part of the question.
So Pivot to Growth, we started in 2023. It was a 3-part plan: return to growth, accelerate growth and maintain growth. So we're
MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA said its “Pivot to Growth” strategy has moved into its second phase, with management pointing to momentum in branded medicines, a stabilized generics business, an expanding biosimilars portfolio and a strengthened balance sheet.
Speaking at a Morgan Stanley event, President and Chief Executive Officer Richard Francis said the company began the strategy in 2023 with goals to return to growth, accelerate growth and maintain growth. The strategy is built around four pillars: delivering on its growth engine, stepping up innovation, creating a generics powerhouse, and focusing the business and capital allocation.
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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowFrancis said Teva has sought to transform from a pure-play generics company into a biopharmaceutical company, supported by growth products including AUSTEDO, AJOVY and UZEDY. He also highlighted Teva’s first deal with Amylyx as aligned with its central nervous system strategy.
The company has also reduced debt and achieved investment-grade ratings from all three major ratings agencies more than a year earlier than it had projected, according to Francis. He said Teva completed an oversubscribed refinancing in the prior week and had converted ADS shares into ordinary shares, a move he said could broaden investor access to the company.
AUSTEDO and AJOVY Growth Outlook 2 Generic Drug Stocks Ready to Surge in 2025Francis reiterated his confidence that AUSTEDO can generate more than $3 billion in sales over time. Teva had previously targeted $2.5 billion in AUSTEDO sales, and Francis said the company now appears positioned to reach that milestone a year ahead of its earlier timetable. He did not provide 2027 guidance, saying the company would offer further details after reviewing third- and fourth-quarter data.
He cited a large untreated population of patients with tardive dyskinesia and Teva’s ability to identify patients, move them onto therapy, optimize dosing and support adherence as drivers of the product’s opportunity. Francis acknowledged that the market is competitive, but said Teva has focused on resource allocation and commercial execution rather than commenting on competitors.
AJOVY has also outperformed the injectable CGRP market, according to Francis. He said Teva’s prior ambition was for the migraine treatment to exceed $1 billion in sales, a threshold it is approaching faster than expected. Management may issue updated AJOVY guidance, he said, while cautioning that the duration of its above-market growth remains to be seen.
Francis attributed performance across AJOVY, AUSTEDO and UZEDY to the company’s commercial capabilities and operational focus across regions.
UZEDY, Olanzapine and Generics On UZEDY, Teva’s long-acting injectable risperidone treatment, Francis said the product has gained traction in a competitive market and that the company is now the leading long-acting injectable in risperidone. He said Teva has doubled the risperidone long-acting injectable market during its time in the category.
Teva sees a potential opportunity to launch its long-acting injectable olanzapine product outside the U.S., although Francis said pricing will be an important consideration. The company has not included an international UZEDY contribution in its forecast, he said.
Combined, Teva has projected UZEDY and olanzapine could generate $1.5 billion to $2 billion. Francis said upside could depend on long-acting injectable penetration, U.S. Medicare access and European launches at appropriate pricing.
For olanzapine in the U.S., Francis said the initial focus will be on sampling and securing hospital formulary access. He identified state-by-state Medicaid access as the principal near-term limiting factor, estimating that roughly 85% of the Medicaid market could be accessible after 12 months. He said Teva does not expect to seek Medicare access through discounts that it considers inconsistent with the product’s value.
In generics, Francis said the business has moved from years of decline to three-year compound annual growth, driven by launches, manufacturing improvements, supply reliability and commercial execution. He said the next major portfolio shift will be a growing contribution from biosimilars.
Teva has 11 biosimilars in the market, Francis said. The company expects to add roughly nine more by the end of the decade. Its broader biosimilars portfolio includes approximately 26 to 29 products, he said. Francis said Teva was on track to exceed its $800 million biosimilars target for 2027 a year early, supported by opportunities in both the U.S. and Europe.
Pipeline and Business Development Eric Hughes, Teva’s executive vice president of global research and development and chief medical officer, discussed duvakitug, the company’s TL1A therapy being developed with Sanofi for ulcerative colitis and Crohn’s disease. Hughes said phase 2 results showed what he described as the highest results reported for the class, while maintenance data released this year was competitive across both diseases.
Teva believes duvakitug could be within an 18-month window of competitors in ulcerative colitis, Hughes said, while characterizing its Crohn’s disease program as being in the middle of the competitive group. He added that eventual outcomes will depend on late-stage data.
Hughes also cited development work for TL1A in hidradenitis suppurativa, saying the disease has substantial unmet need and that the mechanism could address multiple inflammatory and fibrotic pathways.
For ecopipam, Teva filed a new drug application in June and has received priority review, according to Hughes. The company expects a potential launch in the first half of 2027. Hughes described ecopipam as a first-in-class D1 antagonist for Tourette’s disease and said its studies showed about a 30% effect versus placebo, with a safety profile that did not show the side effects associated with D2 antagonists.
Looking ahead, Francis said Teva is interested in selective business-development opportunities in CNS, immunology, respiratory medicine and rare diseases. He said the company does not face a “desperate need” to make acquisitions, but may pursue thoughtful in-licensing or smaller transactions that can provide additional assets for its development and commercial organizations.
About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.
Teva's specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
Should You Invest $1,000 in Teva Pharmaceutical Industries Right Now?Before you consider Teva Pharmaceutical Industries, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Teva Pharmaceutical Industries wasn't on the list.
While Teva Pharmaceutical Industries currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
With the proliferation of data centers and electric vehicles, the electric grid will only get more strained. Download this report to learn how energy stocks can play a role in your portfolio as the global demand for energy continues to grow.
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PARSIPPANY, N.J. and TEL AVIV, Israel, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a global biopharmaceutical company, today announced that its ordinary shares will begin trading today directly on the New York Stock Exchange (NYSE) completing the company’s planned transition from its American Depositary Shares (ADSs) program. Teva’s shares continue to trade under the same ticker symbol “TEVA” on both the NYSE and the Tel Aviv Stock Exchange (TASE).
“Today marks another meaningful milestone in Teva’s transformation,” said Richard Francis, President and CEO of Teva. “The trading of our ordinary shares on the NYSE is expected to broaden investor access to our shares and reflects the momentum we are building through our Pivot to Growth strategy. We remain focused on delivering for patients, driving sustainable growth, and accelerating our transformation into a leading innovative biopharmaceutical company.”
“Our move to a direct ordinary share listing is an important step in strengthening our position in the U.S. capital markets,” said Eli Kalif, Executive Vice President, and Chief Financial Officer of Teva. “Together with our recent return to investment-grade credit ratings from all three major ratings agencies, this milestone demonstrates the strength of our financial transformation, expands our access to investors and enhances our ability to invest for long-term growth.”
Teva’s direct listing comes as the company continues to deliver against its Pivot to Growth strategy, transforming into a leading biopharmaceutical company, driven by a fast-growing innovative medicines portfolio and powered by a leading generics business. Year to date its three flagship innovative brands, AUSTEDO®, AJOVY®, and UZEDY®, have grown collectively by more than 40% year-over-year*, with expected 2026 revenues of approximately $3.7 billion. Investment-grade ratings across all three major agencies further underscore Teva’s financial strength, disciplined execution, and continued debt reduction. With multiple near-term pipeline and commercial catalysts ahead, including an innovative pipeline with a potential of more than $10 billion in peak revenues, Teva is well positioned to expand margins, grow earnings and create significant long-term shareholder value.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars, and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All in for Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward Looking Statements
This Press Release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. These forward-looking statements include statements concerning our plans, strategies, objectives, and any other information that is not historical information. You can identify these forward-looking statements by the use of words such as “will,” “should,” “expect,” “anticipate,” “may,” “project,” “intend,” “plan,” “believe,” “transition” and other words and terms of similar meaning and expression in connection with any discussion of future performance developments. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully implement the process for terminating our ADS program and directly list our ordinary shares in lieu of the ADSs on the NYSE and to achieve our aims as a result of such process, as described in Part II, Item 5 of our Quarterly Report on Form 10-Q for the second quarter of 2026; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to attract investors, incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Other Information.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/12f4d600-2bc1-4523-a309-25fd649b40b1
Teva Begins Trading Ordinary Shares Directly on the NYSE Teva Pharmaceutical Industries Ltd Begins Trading Ordinary Shares Directly on the NYSE, Marking a Mi...
TEL AVIV, Israel, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) (“Teva”) announced today that it successfully priced its offering of approximately $4.9 billion (equivalent) of senior notes (the “Notes”). Teva expects to use the net proceeds from the offering, together with cash on hand, (i) to fund the redemptions of certain existing notes as further set out below (the “Conditional Redemptions”), (ii) to pay fees and expenses in connection therewith and (iii) to the extent of any remaining proceeds, for general corporate purposes, including the repayment of outstanding debt upon maturity, tender offer or earlier redemption. Net proceeds may be temporarily invested pending application for their stated purpose.
The Notes that successfully priced today consist of (i) Teva Pharmaceutical Finance Netherlands II B.V.’s (“Teva Finance II”) €1,000,000,000 aggregate principal amount of 4.250% EUR-denominated Senior Notes maturing in 2033, (ii) Teva Finance II’s €500,000,000 aggregate principal amount of 4.625% EUR-denominated Senior Notes maturing in 2036, (iii) Teva Pharmaceutical Finance Netherlands III B.V.’s (“Teva Finance III”) $1,000,000,000 aggregate principal amount of 5.500% USD-denominated Senior Notes maturing in 2034, (iv) Teva Finance III’s $1,000,000,000 aggregate principal amount of 5.750% USD-denominated Senior Notes maturing in 2037, and (v) Teva Pharmaceutical Finance Netherlands IV B.V.’s (“Teva Finance IV” and, together with Teva Finance II and Teva Finance III, the “Issuers”) $1,200,000,000 aggregate principal amount of 5.250% USD-denominated Senior Notes maturing in 2032.
The settlement of the Notes is expected to occur on or about September 16, 2026, subject to customary closing conditions. The settlement of the Notes in the amount indicated herein will satisfy the condition of the Conditional Redemptions that the applicable Issuers receive funding in an amount satisfactory to each such Issuer and in any case sufficient to pay the redemption price for the applicable series of notes in full and to cover all related expenses.
The Notes will be unsecured senior obligations of the Issuers and will be unconditionally guaranteed on a senior unsecured basis by Teva.
In connection with the Conditional Redemptions, Teva issued notices of conditional redemption on September 8, 2026, pursuant to which it intends to redeem in accordance with the terms set forth in the relevant indentures: (i) all of the 6.750% Senior Notes due 2028 that are outstanding, (ii) all of the 7.875% Sustainability-Linked Senior Notes due 2029 that are outstanding, (iii) all of the 7.375% Sustainability-Linked Senior Notes due 2029 that are outstanding, (iv) up to $450,000,000 in principal amount of 4.750% Sustainability-Linked Senior Notes due 2027 and (v) up to €1,250,000,000 in principal amount of 4.375% Sustainability-Linked Senior Notes due 2030. Teva may, in its sole discretion, decide to issue additional notices of conditional redemption and redeem certain of its other outstanding notes, or to amend the principal amounts to be redeemed under any of the foregoing notices, in each case in accordance with the terms set forth in the relevant indentures pursuant to which such notes were issued, although it is under no obligation to do so. On September 10, 2026, Teva expects to (a) issue an additional notice of conditional redemption pursuant to which Teva intends to redeem all of the 8.125% USD Sustainability-Linked Senior Notes due 2031 and (b) issue a notice of reduction pursuant to which Teva intend to reduce the amount of 4.375% Sustainability-Linked Senior Notes due 2030 being redeemed from up to €1,250,000,000 to €1,150,000,000.
The offering and sale of the Notes were made pursuant to our effective automatic shelf registration statement on Form S-3, including our base prospectus, filed with the Securities and Exchange Commission (the “SEC”) on February 7, 2025. The offering of these Notes was made only by means of a prospectus supplement and accompanying base prospectus, which have been filed with the SEC. Before you invest, you should read the prospectus supplement and accompanying prospectus along with other documents that Teva has filed with the SEC and that are incorporated by reference into the prospectus supplement and accompanying base prospectus for more complete information about Teva and this offering. These documents are available at no charge by visiting EDGAR on the SEC website at http://www.sec.gov. Alternatively, a copy of the prospectus supplement and accompanying base prospectus related to this offering may be obtained, when available, by contacting BNP PARIBAS, 16, boulevard des Italiens, 75009 Paris, France, Attention: Fixed Income Syndicate (emails: [email protected]); BNP Paribas Securities Corp., 787 Seventh Avenue, New York, New York 10019, United States of America, Attention: Debt Syndicate Desk (email: [email protected]); Citigroup Global Markets Europe AG or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, United States of America, Telephone: (800) 831-9146, E-mail: [email protected]; Goldman Sachs Bank Europe SE, Marienturm, Taunusanlage 9-10, 60329 Frankfurt am Main, Germany, Attention: High Yield Syndicate Desk (Tel: +49 69 7532 1000, Fax: +44 (0)207 774 2330); J.P. Morgan SE, Taunustor 1 (TaunusTurm), 60310 Frankfurt am Main, Germany, Attention: Head of EMEA Capital Markets Group (email: [email protected]) and J.P. Morgan Securities LLC, 270 Park Avenue, New York, New York 10017, United States of America, Attention: Investment Grade Syndicate Desk, Tel: (212) 834-6081).
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: completion of the offering of senior notes and conditional redemptions for certain outstanding notes; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026, in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward Looking Statements,” and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. No assurance can be given that the transactions described herein will be consummated or as to the ultimate terms of any such transactions.
It may be unlawful to distribute this press release in certain jurisdictions. This press release is not for distribution in Canada, Japan or Australia. The information in this press release does not constitute an offer of securities for sale in Canada, Japan or Australia.
The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area (“EEA”). For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, “MiFID II”); or (ii) a customer within the meaning of Directive 2016/97/EU (as amended, the “Insurance Distribution Directive”), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or (iii) not a qualified investor as defined in Article 2 of Regulation (EU) 2017/1129. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the “PRIIPs Regulation”) for offering or selling the Notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling the Notes or otherwise making them available to any retail investor in the EEA may be unlawful under the PRIIPs Regulation.
The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investors in the United Kingdom. For these purposes, the expression “retail investor” means a person who is either one (or both of the following): (i) not a professional client, as defined in point (8) of Article 2(1) of Regulation (EU) No. 600/2014 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018; or (ii) not a qualified investor as defined in paragraph 15 of Schedule 1 to the Public Offers and Admission to Trading Regulations 2024. Consequently, no disclosure document required by FCA Product Disclosure Sourcebook (“DISC”) for offering, selling, or distributing the Notes or otherwise making them available to retail investors in the UK has been prepared and, therefore, offering, selling, or distributing the notes or otherwise making them available to any retail investor in the UK may be unlawful under the DISC and the Consumer Composite Investments (Designated Activities) Regulations 2024.
Promotion of the Notes in the United Kingdom is restricted by the Financial Services and Markets Act 2000 (“FSMA”), and accordingly, the Notes are not being promoted to the general public in the United Kingdom. This announcement is for distribution only to, and is only directed at (i) persons who are outside the United Kingdom or (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), (iii) high net worth entities, and other persons to whom they may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iv) persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) in connection with the issue or sale of any notes may otherwise lawfully be communicated or caused to be communicated (all such persons together being referred to as “relevant persons”).The Notes will only be available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Notes will be engaged in only with, relevant persons. This announcement is directed only at relevant persons and must not be acted on or relied on by anyone who is not a relevant person.
The Notes have not, may not and will not be offered, sold or delivered in the Netherlands, other than to qualified investors (as defined in Regulation (EU) 2017/1129).
The Notes have not, may not and will not be offered, sold or delivered in Israel, other than to persons who qualify as one of the types of investors listed in the First Addendum to the Israeli Securities Law, subject to and in accordance with the requirements set forth in the First Addendum to the Israeli Securities Law.
Greenland Capital Management LP cut its position in shares of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) by 25.6% during the second quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The institutional investor owned 80,000 shares of the company's stock after selling 27,500 shares during the
TEL AVIV, Israel, Sept. 07, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) (“Teva”) announced today its intention to issue senior notes through its special purpose finance subsidiaries. Teva Pharmaceutical Finance Netherlands II B.V. (“Teva Finance II”) intends to offer EUR-denominated Senior Notes (the “Euro Notes”) and Teva Pharmaceutical Finance Netherlands III B.V. (“Teva Finance III”) and Teva Pharmaceutical Finance Netherlands IV B.V. (“Teva Finance IV” and, together with Teva Finance II and Teva Finance III, the “Issuers”) intend to offer USD-denominated Senior Notes (the “USD Notes” and, together with the Euro Notes, the “Notes”).
The offering of Notes is subject to, among other things, market conditions. Teva expects to use the net proceeds from the offering, together with cash on hand, (i) to fund the redemptions of certain existing notes as further set out below (the “Conditional Redemptions”), (ii) to pay fees and expenses in connection therewith and (iii) to the extent of any remaining proceeds, for general corporate purposes, including the repayment of outstanding debt upon maturity, tender offer or earlier redemption.
In connection with the Conditional Redemptions, Teva intends to issue notices of conditional redemption pursuant to which it intends to redeem in accordance with the terms set forth in the relevant indentures: (i) all of the 6.750% Senior Notes due 2028 that are outstanding, (ii) all of the 7.875% Sustainability-Linked Senior Notes due 2029 that are outstanding, (iii) all of the 7.375% Sustainability-Linked Senior Notes due 2029 that are outstanding, (iv) up to $450,000,000 in principal amount of 4.750% Sustainability-Linked Senior Notes due 2027 and (v) up to €1,250,000,000 in principal amount of 4.375% Sustainability-Linked Senior Notes due 2030. The Conditional Redemptions are expected to be conditioned on the consummation of the offering. The offering, however, is not conditioned on the Conditional Redemptions. Teva may, in its sole discretion, decide to issue additional notices of conditional redemption and redeem certain of its other outstanding notes, or to amend the principal amounts to be redeemed under any of the foregoing notices, in each case in accordance with the terms set forth in the relevant indentures pursuant to which such notes were issued, although it is under no obligation to do so.
Net proceeds may be temporarily invested pending application for their stated purpose.
The Notes will be unsecured senior obligations of the Issuers and will be unconditionally guaranteed on a senior basis by Teva.
The offering and sale of the Notes will be made pursuant to our effective automatic shelf registration statement on Form S-3, including our base prospectus, filed with the Securities and Exchange Commission (the “SEC”) on February 7, 2025. The offering of these Notes will be made only by means of a prospectus supplement and accompanying base prospectus, which have been filed with the SEC. Before you invest, you should read the prospectus supplement and accompanying prospectus along with other documents that Teva has filed with the SEC and that are incorporated by reference into the prospectus supplement and accompanying base prospectus for more complete information about Teva and this offering. These documents are available at no charge by visiting EDGAR on the SEC website at http://www.sec.gov. Alternatively, a copy of the prospectus supplement and accompanying base prospectus related to this offering may be obtained, when available, by contacting BNP PARIBAS, 16, boulevard des Italiens, 75009 Paris, France, Attention: Fixed Income Syndicate (emails: [email protected]); BNP Paribas Securities Corp., 787 Seventh Avenue, New York, New York 10019, United States of America, Attention: Debt Syndicate Desk (email: [email protected]); Citigroup Global Markets Europe AG or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, United States of America, Telephone: (800) 831-9146, E-mail: [email protected]; Goldman Sachs Bank Europe SE, Marienturm, Taunusanlage 9-10, 60329 Frankfurt am Main, Germany, Attention: High Yield Syndicate Desk (Tel: +49 69 7532 1000, Fax: +44 (0)207 774 2330); J.P. Morgan SE, Taunustor 1 (TaunusTurm), 60310 Frankfurt am Main, Germany, Attention: Head of EMEA Capital Markets Group (email: [email protected]) and J.P. Morgan Securities LLC, 270 Park Avenue, New York, New York 10017, United States of America, Attention: Investment Grade Syndicate Desk, Tel: (212) 834-6081).
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: completion of the offering of senior notes and conditional redemptions for certain outstanding notes; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026, in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward Looking Statements,” and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
It may be unlawful to distribute this press release in certain jurisdictions. This press release is not for distribution in Canada, Japan or Australia. The information in this press release does not constitute an offer of securities for sale in Canada, Japan or Australia.
The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area (“EEA”). For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, “MiFID II”); or (ii) a customer within the meaning of Directive 2016/97/EU (as amended, the “Insurance Distribution Directive”), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or (iii) not a qualified investor as defined in Article 2 of Regulation (EU) 2017/1129. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the “PRIIPs Regulation”) for offering or selling the Notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling the Notes or otherwise making them available to any retail investor in the EEA may be unlawful under the PRIIPs Regulation.
The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investors in the United Kingdom. For these purposes, a retail investor means a person who is neither: (i) a professional client, as defined in point (8) of the UK MiFIR; nor (ii) a qualified investor as defined in paragraph 15 of Schedule 1 to the POATRs. Consequently, no disclosure document required by DISC for offering or selling, or distributing the Notes or otherwise making them available to retail investors in the UK has been prepared and, therefore, offering or selling, or distributing the notes or otherwise making them available to any retail investor in the UK may be unlawful under the DISC and the Consumer Composite Investments (Designated Activities) Regulations 2024.
Promotion of the Notes in the United Kingdom is restricted by the FSMA, and accordingly, the Notes are not being promoted to the general public in the United Kingdom. This announcement is for distribution only to, and is only directed at, persons who are (i) outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), (iii) high net worth entities, and other persons to whom they may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iv) persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) in connection with the issue or sale of any notes may otherwise lawfully be communicated or caused to be communicated (all such persons together being referred to as “relevant persons”). The Notes will only be available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Notes will be engaged in only with, relevant persons. This announcement is directed only at relevant persons and must not be acted on or relied on by anyone who is not a relevant person.
The Notes have not, may not and will not be offered, sold or delivered in the Netherlands, other than to qualified investors (as defined in Regulation (EU) 2017/1129).
The Notes have not, may not and will not be offered, sold or delivered in Israel, other than to persons who qualify as one of the types of investors listed in the First Addendum to the Israeli Securities Law, subject to and in accordance with the requirements set forth in the First Addendum to the Israeli Securities Law.
S&P Global Ratings Upgrades Teva to BBB-, Marking Third Credit Rating Upgrade in Recent Months and Reflecting Strong Execution and Financial Discipline
Key Takeaways Teva's TEV '408 met the primary endpoint in a phase IIa study in adults with celiac disease.TEV '408 reduced gluten-induced intestinal damage, inflammation and gastrointestinal symptoms versus placebo.TEV '408's celiac and vitiligo programs support its potential as a pipeline-in-a-product opportunity. Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the phase IIa study, which evaluated its investigational anti-interleukin-15 monoclonal antibody, TEV ‘408, in adult patients with celiac disease, has met its primary endpoint.
Data from the study showed that treatment with a single subcutaneous dose of TEV ‘408 led to a statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8.
TEV ‘408 showed a favorable effect on intestinal inflammation and lower gastrointestinal symptom scores versus placebo. Treatment with TEV ‘408 was also generally well-tolerated, with no safety signals reported to date.
The randomized, placebo-controlled phase IIa study enrolled 50 adult patients with celiac disease who were following a gluten-free diet. Teva said additional analyses from the study are currently underway and plans to present further data at a future medical conference.
Currently, there are no approved therapies for treating celiac disease.
TEVA’s Price PerformanceYear to date, shares of Teva have rallied 20.1% compared with the industry’s increase of 6.1%.
Image Source: Zacks Investment Research
More on TEVA’s Development Activities With TEV ‘408Besides celiac disease, TEV-'408 is also being developed for vitiligo.
In July 2026, Teva announced plans to advance its investigational anti-IL-15 antibody TEV-'408 into a phase IIb study for vitiligo in the fourth quarter of 2026 following encouraging phase Ib results.
Designed for once-every-12-week subcutaneous dosing, TEV-'408 targets the IL-15 pathway, a key driver of vitiligo biology, and could provide a convenient treatment option for patients with limited therapeutic alternatives.
Per management, the above-mentioned celiac disease results, together with its vitiligo program, further support TEV ‘408’s potential as a pipeline-in-a-product opportunity in multiple diseases.
Teva also has several key branded pipeline assets in neuroscience and immunology, which it believes represent a multi-billion-dollar commercial opportunity. These include olanzapine LAI, a long-acting subcutaneous injectable for schizophrenia, and ecopipam, which was acquired through Emalex Biosciences and is being developed for pediatric Tourette syndrome. Both candidates are under U.S. regulatory review, with Teva targeting potential launches of olanzapine LAI in the fourth quarter of 2026 and ecopipam in the first half of 2027, subject to approval.
Another key pipeline asset is duvakitug, a late-stage anti-TL1A therapy being developed for inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. Teva believes duvakitug also has pipeline-in-a-product potential.
TEVA's Zacks Rank & Stocks to ConsiderTeva currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 5.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share, while estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 124.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents, while estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 67.5% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
Teva Pharmaceutical Industries Limited (TEVA) Discusses Positive Topline Results for Anti-IL-15 Antibody in Phase IIa Celiac Disease Study September 2, 2026 8:00 AM EDT
Company Participants
Christopher Stevo - Senior Vice President of Investor Relations & Competitive Intelligence
Richard Francis - President, CEO & Director
Eric Hughes - Executive VP of Global R&D and Chief Medical Officer
Conference Call Participants
David Amsellem - Piper Sandler & Co., Research Division
Corey Rosenbaum - Scotiabank Global Banking and Markets, Research Division
Anthea Li - Jefferies LLC, Research Division
Jason Gerberry - BofA Securities, Research Division
Matthew Dellatorre - Goldman Sachs Group, Inc., Research Division
Ashwani Verma - UBS Investment Bank, Research Division
Umer Raffat - Evercore ISI Institutional Equities, Research Division
Luisa Hector - Joh. Berenberg, Gossler & Co. KG, Research Division
Presentation
Operator
Hello, everyone, and thank you for joining us today for the IL-15 Celiac Disease Phase 2a Topline Results Conference Call. My name is Sami, and I'll be coordinating your call today. [Operator Instructions] I'll now hand over to your host, Christopher Stevo, Head of IR, to begin. Please go ahead, Christopher.
Christopher Stevo
Senior Vice President of Investor Relations & Competitive Intelligence
Thanks, Sami. Good morning, and good afternoon, everyone. Thank you for joining us for the celiac disease results for TEV-'408 (Anti-IL-15). The materials are posted to our website this morning in the Investor Relations section, as always, please see those.
And before I turn the call over to Richard Francis, I'd like to remind everyone that we'll be making forward-looking statements on this call. The company cautions investors that any forward-looking statement involves risks and uncertainties and is not a guarantee of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors.
These factors are described in our earnings press release
MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA reported positive topline results from a Phase IIa gluten-challenge study of TEV-408, its anti-IL-15 antibody candidate for celiac disease, with the company saying the treatment met its primary endpoint and showed statistically significant effects on key measures of intestinal damage.
The randomized study enrolled 50 adults with celiac disease, assigning participants one-to-one to TEV-408 or placebo. Patients received a single dose on day one, followed two weeks later by a six-week gluten challenge of 3 grams per day, an amount Teva described as roughly equivalent to a slice of standard bread.
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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowAccording to Eric Hughes, Teva’s executive vice president of global R&D and chief medical officer, the study evaluated the ratio of villous height to crypt depth, a biopsy-based measure of intestinal injury in celiac disease. The placebo group saw its ratio decline by 0.88, compared with a 0.43 decline in the TEV-408 group, producing a treatment-placebo difference of 0.45.
Hughes said the 0.4 threshold is considered clinically meaningful and that the primary endpoint was statistically significant. The company also reported a statistically significant result on intraepithelial lymphocytes, immune cells associated with inflammation and intestinal damage in celiac disease. The placebo group experienced an increase of 27.6 cells per 100 enterocytes, while the TEV-408 group saw little change, resulting in a reported delta of 27.23.
Single-Dose Study and Safety Profile 2 Generic Drug Stocks Ready to Surge in 2025Teva said the study’s results followed only one dose of TEV-408, despite the antibody’s potential dosing schedule of once every three months. Hughes said Phase I data showed an approximately 38-day half-life and suppression of free IL-15 to essentially below detectable levels for 80 to 90 days at higher tested doses.
The company characterized the treatment as well tolerated to date, with no concerning safety signals identified across its development program. Teva said it has conducted a Phase I program involving 115 participants with follow-up extending to two years, in addition to an earlier Phase Ib celiac disease challenge study and clinical data in vitiligo.
In the prior celiac study, Teva observed changes in fatty acid-binding protein, a biomarker associated with gut inflammation. Hughes said those results suggested TEV-408 may have protected the gut from gluten exposure and potentially affected underlying “smoldering” disease activity.
TEV-408 has received Fast Track designation in celiac disease, Hughes said. Teva plans to present the new data to the U.S. Food and Drug Administration and other regulators to determine the next stage of development.
Next Steps in Celiac Disease Development Hughes said future Phase II work is expected to include dose-ranging of TEV-408 itself, longer treatment exposure and further evaluation of both biopsy findings and patient-reported symptoms. Teva used the Celiac Disease Symptom Diary in the Phase IIa study and reported a trend toward protection from symptoms including abdominal pain, diarrhea, nausea, bloating and fatigue.
The company did not provide timing for the next celiac Phase II study or a subsequent Phase III program, saying those plans will depend on discussions with regulators. Hughes said Teva is considering studies involving lower-level, simulated inadvertent gluten exposure for longer-duration trials, rather than the more intensive gluten challenge used in the proof-of-concept study.
On longer-term safety requirements, Hughes said programs generally require approximately 300 patients with six months of exposure and a total safety database of roughly 1,000 to 1,400 patients, while noting that final requirements could vary.
Teva said it also plans to develop TEV-408 in vitiligo through a seamless Phase II/III design expected to begin this year. The company may later consider additional IL-15-mediated conditions, including alopecia areata, eosinophilic esophagitis and potentially atopic dermatitis.
Broader Pipeline Strategy President and CEO Richard Francis said the TEV-408 results represent progress in Teva’s “Pivot to Growth” strategy, which aims to expand the company’s innovative medicines portfolio alongside its generics business. Francis said Teva sees an opportunity for five product submissions over five years and that its highlighted programs and indications have the potential to generate more than $10 billion in sales over time.
Francis said Teva does not currently plan to partner TEV-408, citing its commercial capabilities and its ability to fund development across multiple indications. He also highlighted upcoming milestones, including completion of the DARI asthma study, a futility analysis for emrusolmin, a potential fourth-quarter launch of long-acting olanzapine and a planned early-2027 ecopipam launch following priority review.
About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. NYSE: TEVA is an Israeli multinational pharmaceutical company and one of the world's largest manufacturers of generic medicines. The company's core activities include the development, production and marketing of generic pharmaceuticals alongside a portfolio of specialty branded medicines. Teva supplies finished dosage forms and active pharmaceutical ingredients (APIs) to markets around the globe and operates manufacturing and research facilities in multiple countries.
Teva's product range covers oral solids, injectables, inhalation products and other dosage forms across therapeutic areas such as central nervous system disorders, respiratory, oncology, pain and infectious disease.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) shares are trading higher after the company announced positive topline results from an ongoing Phase 2a study of TEV ‘408. The study met its primary endpoint.
Teva stock is trading at elevated levels. Where are TEVA shares going? TEV ‘408 Shows Promise in Celiac DiseaseTEV ‘408, an investigational anti-interleukin-15 monoclonal antibody, demonstrated statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo in adults with celiac disease. The study’s primary endpoint measured the villous height-to-crypt depth ratio, showing least squares mean change from baseline of -0.43 for TEV ‘408 compared with -0.88 for placebo. The drug also showed a favorable effect on intestinal inflammation and demonstrated lower gastrointestinal symptom scores versus placebo. TEV ‘408 was well-tolerated, with no safety signals observed to date.
“A strict gluten-free diet has long been the only option for people living with celiac disease. Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage and a significant impact on their daily lives,” said Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source.”
TEV ‘408 Advances with Vitiligo Study and Strategic FundingTEV ‘408 is also being evaluated as a treatment for vitiligo, with Teva advancing the drug into a Phase 2b study in that indication following encouraging Phase 1b results. Teva entered a strategic funding agreement with Royalty Pharma in January 2026, under which Teva is eligible to receive up to $500 million to accelerate the clinical development of TEV ‘408.
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Teva Shares Edge HigherTEVA Price Action: At the time of publication, Teva shares are trading 2.74% higher at $37.18, according to data from Benzinga Pro.
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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) on Wednesday reported encouraging topline outcomes from an active Phase 2a clinical trial evaluating TEV ‘408, an experimental anti-interleukin-15 monoclonal antibody, for celiac disease.
Coeliac disease is a chronic autoimmune condition where eating gluten damages the lining of the small intestine.
The trial successfully achieved its primary goal, revealing that the investigational treatment significantly prevented intestinal damage caused by gluten consumption when compared to a placebo at the eight-week mark.
Study Design And Clinical MethodologyResearchers enrolled 50 adult patients diagnosed with celiac disease who maintained a strict gluten-free diet and displayed minimal intestinal damage at the study’s onset.
Two weeks following a single administration of the TEV ‘408 antibody, the participants initiated a rigorous six-week daily gluten challenge.
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The clinical trial team evaluated patient-reported symptoms alongside comprehensive biopsy measurements to track intestinal inflammation and structural damage.
Key Efficacy And Inflammation MetricsAt the conclusion of the eight-week gluten challenge, TEV ‘408 demonstrated a clinically meaningful defense against gluten-induced damage.
The treatment yielded a least squares mean change in the trial’s primary endpoint, the villous height-to-crypt depth ratio, of -0.43. This significantly outperformed the placebo group’s -0.88 change.
Furthermore, the investigational antibody positively impacted intestinal inflammation.
Participants receiving TEV ‘408 experienced a minimal increase of 0.37 in intraepithelial lymphocyte density. In contrast, the placebo group saw a substantial surge of 27.60 in the same inflammatory marker.
Symptom Relief And Ongoing ResearchPatients treated with TEV ‘408 also recorded lower gastrointestinal symptom scores on the Celiac Disease Symptom Diary when compared to those taking the placebo.
Medical professionals noted that participants tolerated the treatment well, with no emerging safety concerns or signals identified throughout the process.
Teva is currently conducting additional analyses of the ongoing Phase 2a study.
TEVA Price Action: Teva Pharmaceutical Indus shares were up 3.04% at $37.29 at the time of publication on Wednesday. The stock is approaching its 52-week high of $38.36, according to Benzinga Pro data.
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Teva-discovered TEV ‘408, a novel anti-IL-15 monoclonal antibody, demonstrated statistically significant and clinically meaningful prevention of gluten-induced intestinal damage vs placebo following a single subcutaneous dose.TEV ‘408 was well-tolerated with no safety signals observed to date.Together with the vitiligo program, the celiac disease topline results further support TEV ‘408 as a potential pipeline-in-a-product opportunity in multiple diseases. Teva will hold an investor call and live webcast today,
Wednesday, September 2, 2026, at 8:00 a.m. ET to discuss these data.
TEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from an ongoing Phase 2a study of TEV ‘408, an investigational anti-interleukin-15 monoclonal antibody, in adults with celiac disease. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8. TEV ‘408 was well-tolerated, with no safety signals observed to date.
“A strict gluten-free diet has long been the only option for people living with celiac disease. Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage and a significant impact on their daily lives,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source. They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage.”
The ongoing randomized, placebo-controlled study enrolled 50 adult participants with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage at baseline as measured by the villous height-to-crypt depth ratio (Vh:Cd ≥2.0) and symptoms. Two weeks after receiving a single dose of TEV ‘408, participants began a six-week daily gluten challenge (GC). The study assessed biopsy-based measures of intestinal damage and inflammation along with patient-reported symptoms. At week 8 (the end of the GC) TEV ‘408:
Showed statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo, as measured by the trial’s primary endpoint of Vh:Cd ratio with a least squares (LS) mean change from baseline of -0.43 compared with -0.88 for placebo (treatment difference of 0.45, 95% CI: (0.06, 0.84), p<0.05).Showed a favorable effect on intestinal inflammation as measured by density of intraepithelial lymphocytes (IELs) compared with placebo; the LS Mean change from baseline in the density of IELs, was an increase of 27.60 for placebo compared to 0.37 for TEV ‘408 treated participants (treatment difference of -27.23, 95% CI: (-39.67, -14.79)).Demonstrated lower GI symptom scores versus placebo, as assessed using the Celiac Disease Symptom Diary (CDSD), a patient-reported outcome (PRO).Was well-tolerated with no emerging safety signals. Additional analyses from the ongoing Phase 2a study are underway. Teva plans to present further data from the study at a future scientific meeting.
Teva Investor Call
Teva will hold an investor call and live webcast today, Wednesday, September 2, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET to discuss these data. To participate, please register in advance here. To access a live webcast of the presentation, visit Teva’s Investor Relations website. An archived version of the webcast will be available 24 hours after the end of the live discussion.
About TEV ‘408
TEV ‘408, discovered by Teva, is an investigational human monoclonal antibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in immune-mediated pathways. TEV ‘408 has a high affinity and potency (in vitro) with a prolonged half-life that supports the potential for convenient subcutaneous dosing.
TEV ‘408 is being studied as a potential therapy for celiac disease in a Phase 2a study and was granted Fast Track designation in that indication by the U.S. FDA in May 2025. By blocking IL-15 activity, TEV ‘408 aims to reduce the IL-15-driven intestinal inflammation and damage that are characteristic of celiac disease.
TEV ‘408 is also being evaluated in a Phase 1b study as a treatment for vitiligo. Following encouraging results from the ongoing Phase 1b study in vitiligo, Teva is advancing the investigational asset into a Phase 2b study in vitiligo. By blocking IL-15 activity, TEV ‘408 aims to reduce the immune-mediated destruction of melanocytes (pigment-producing cells) resulting in white patches on the skin characteristic of vitiligo.
Teva entered a strategic funding agreement with Royalty Pharma in January 2026. Under the agreement, Teva is eligible to receive up to $500 million to accelerate the clinical development of TEV ‘408. If approved and launched, Teva will pay a milestone to Royalty Pharma and a royalty on worldwide net sales of TEV ‘408.
About Celiac Disease
Celiac disease is a serious autoimmune disease in which exposure to gluten triggers an immune response that damages the small intestine. It affects approximately 1% of the global population, or more than three million people in the U.S. alone, although many individuals remain undiagnosed. Celiac disease can cause chronic digestive symptoms, fatigue, nutrient deficiencies, and other health complications that can significantly impact daily life.
There are currently no approved therapies for celiac disease. A strict gluten-free diet (GFD) remains the standard of care, yet even with careful adherence, patients may continue to experience symptoms, reduced quality of life, and ongoing intestinal inflammation or damage due to inadvertent gluten exposure. For people living with celiac disease, managing the condition often requires constant vigilance around meals, travel, work, and social activities, creating significant daily burden. The limitations of current management approaches underscore the need for therapies that address the underlying drivers of disease and improve outcomes for patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize TEV-’408 for the treatment of celiac disease and for the treatment of vitiligo; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2392ceaa-b1f3-44a8-bd7e-4c775053e093
Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Ant... Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Ant...
Israeli drugmaker Teva Pharmaceutical Industries (TEVA.TA), said on Wednesday its experimental drug helped prevent gluten-related intestinal damage in adults with celiac disease, meeting the main goal of a mid-stage trial.
U.S.-listed shares of the company were up over 4% in premarket trading.
Celiac disease is an autoimmune condition in which gluten triggers an immune response that damages the small intestine. It affects about 1% of the global population, including more than 3 million people in the United States, according to Teva.
The antibody treatment, known as TEV-408, blocks IL-15, a protein involved in the immune reaction to gluten.
In the study, 50 patients following a gluten-free diet were randomly assigned to receive a subcutaneous injection of TEV-408 or a placebo. Two weeks after receiving a single dose, participants were instructed to consume gluten daily for six weeks.
A single injection significantly reduced damage and inflammation in the small intestine compared with a placebo after eight weeks. Patients also reported fewer digestive symptoms, Teva said, adding that no new safety concerns were identified.
There are no approved treatments for the condition. Patients rely on a strict gluten-free diet, though accidental exposure can still cause symptoms and intestinal damage.
Teva plans further analysis and will present additional results at a future scientific meeting. TEV-408 is also being tested for vitiligo and is set to enter another mid-stage trial for the skin condition.
Royalty Pharma (RPRX.O) agreed in January to provide Teva with up to $500 million to accelerate the drug's development.
PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced a shared commitment with the Trump Administration to lower the cost of select medicines for American patients covered by Medicaid. When finalized, this agreement will support continued investment in scientific innovation and pharmaceutical manufacturing capabilities.
“Teva appreciates the opportunity to work with President Trump and his Administration to expand access and affordability for patients today while enabling continued investment in medicines patients need tomorrow,” said Chris Fox, President, Teva USA. “Teva built its business around delivering affordable medicines to Americans, and we share the Administration’s commitment to improve access to more affordable medicines while investing in scientific innovation and domestic manufacturing capabilities in the U.S.”
Teva remains in active discussions with the Trump Administration to strike a deal anchored in all four of the President’s drug pricing priorities. If an agreement is reached, Teva would align U.S. Medicaid pricing for select medicines with pricing in leading developed markets through the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) framework. The agreement also would include a prospective Most-Favored-Nation (MFN) commitment for applicable future innovative product launches. Additionally, Teva has offered a dedicated reserve of certain active pharmaceutical ingredients (API) in support of public health needs and continued investment into U.S. pharmaceutical manufacturing capabilities. Conditions of the negotiation to reach a final agreement remain confidential.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: the effects of reforms in healthcare regulation and related reductions in pharmaceutical pricing, reimbursement and coverage; U.S. Executive Orders issued in April and May 2025 intended to reduce the prices paid for prescription medicines, including most-favored-nation pricing and related regulatory efforts; our ability to execute the agreement with the U.S. administration to lower the cost of select medicines for patients in the U.S. covered by Medicaid while supporting continued investment in scientific innovation and healthcare system resilience; changes in U.S. administration; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Key Takeaways Teva bids for BioXcel assets, including Igalmi, in a court-supervised auction process.BXCL501 is under FDA review for potential at-home treatment of acute agitation in adults.Teva would pay $57.5 million upfront, with up to $67.5 million in contingent payments. Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced it has made a bid to acquire certain assets of BioXcel Therapeutics, including the Igalmi (dexmedetomidine) sublingual film.
Igalmi, the currently approved formulation of dexmedetomidine sublingual film, is indicated for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorder in adults when administered under the supervision of a healthcare provider.
Teva has agreed to serve as the “stalking horse bidder” in a court-supervised auction process for the assets. The proposed transaction does not involve the complete acquisition of BioXcel as a whole. However, Teva would acquire the assets if it is selected as the successful bidder, subject to bankruptcy court approval, potential higher bids and customary closing conditions.
Year to date, shares of Teva have risen 16.7% compared with the industry’s rise of 6.4%.
Image Source: Zacks Investment Research
TEVA’s Potential Neuroscience OpportunityThe key asset is BXCL501, a novel, orally dissolving dexmedetomidine sublingual film that is currently under FDA review for potential at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. A decision from the regulatory body is expected on Nov. 14, 2026.
If approved, the product could potentially become the first FDA-approved at-home treatment for this condition, providing an option for patients outside traditional healthcare or hospital settings.
The proposed transaction would give Teva worldwide rights to the related assets, including the investigational formulation under FDA review for potential outpatient use.
What's Driving TEVA’s Interest?Under the above agreement, Teva would pay $57.5 million upfront for the assets, with the potential for up to an additional $67.5 million in contingent payments. The additional payments include time-based payments tied to the timing of FDA approval, potential approval delays and specified sales milestones.
The proposed transaction fits Teva’s strategy of pursuing assets that offer a strategic fit, address patient needs and have the potential to generate long-term value. Management expects that, if successful, the deal would strengthen its neuroscience portfolio while maintaining a disciplined approach to capital allocation and risk.
The move underscores Teva’s ongoing focus on targeted business development as part of its Pivot to Growth strategy.
Teva recently expanded its neuroscience pipeline through the acquisition of Emalex Biosciences, adding ecopipam, an investigational therapy being developed for treating pediatric Tourette syndrome.
In August 2026, the FDA accepted the new drug application ("NDA") seeking approval for ecopipam for the treatment of pediatric patients with Tourette syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected in late first quarter of 2027. If approved, ecopipam could become the first new Tourette syndrome therapy in more than 10 years and the first novel mechanism of action in more than 50 years.
TEVA's Zacks Rank & Stocks to ConsiderTeva currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 7.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
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Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.