Original source text
Altimmune, Inc. (ALT) Q1 2026 Earnings Call Transcript Live financial news intelligence
Track market-moving stories before they get noisy
Real-time pulse of financial headlines curated from 5 premium feeds.
Latest market signal
English
Commodities
GOLD
164
SILVER
95
OIL
52
PLATINUM
5
PALLADIUM
2
COPPER
1
- FMP Stock News 32s ago
- FMP Forex News 3m ago
- CoinGecko News 3m ago
- FIO Stock News 7m ago
- Patria Stock News 7m ago
- Editorial rewrite 32s ago
- Asset sync 27m ago
Latest coverage
Market News Feed
Scan headlines quickly, then expand any story for source context.
| Details | Date | Content | Source |
|---|---|---|---|
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-14 00:40
2mo ago
|
Altimmune, Inc. (ALT) Q1 2026 Earnings Call Transcript | FMP Stock News | |
|
|
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-14 11:46
2mo ago
|
Altimmune's Q1 Loss Narrower Than Expected, Revenues Nil | FMP Stock News | |
|
Original source text
Key Takeaways Altimmune reported a narrower Q1 loss as pemvidutide studies advanced across multiple indications.ALT plans a phase III MASH study in H2 2026, with 52-week data expected in 2029.ALT expects top-line AUD study data in Q3 2026 as ALD enrollment progresses toward completion. Altimmune (ALT - Free Report) incurred a first-quarter 2026 loss of 18 cents per share, narrower than the Zacks Consensus Estimate of a loss of 25 cents. The company had recorded a loss of 26 cents per share in the year-ago quarter.The company did not generate any revenues in the first quarter, as it does not have a marketed drug in its portfolio. ALT's Q1 Results in DetailResearch and development (R&D) expenses totaled $16.2 million in the reported quarter, up 2.3% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage metabolic dysfunction-associated steatohepatitis (MASH) study. R&D spending included $9.5 million in direct pemvidutide development costs. General and administrative expenses were $8.1 million, up 34.3% year over year, primarily driven by an increase in severance costs and professional fees. As of March 31, 2026, Altimmune had cash, cash equivalents and short-term investments of $332 million compared with $274 million as of Dec. 31, 2025. The company raised $75 million in a registered direct and $8 million via ATM in January-February 2026 and secured $225 million in gross proceeds from an oversubscribed public offering completed in April 2026, bringing pro forma cash to roughly $535 million as of April 30, 2026. Management expects its cash runway to support operations into 2029. Year to date, shares of ALT have declined 16.4% compared with the industry’s 5.4% decline. Image Source: Zacks Investment Research ALT's Key Pipeline UpdatesPemvidutide, Altimmune’s lead candidate, is an investigational dual glucagon/GLP-1 receptor agonist, being developed for MASH, alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). Altimmune had announced 48-week data from the phase IIb IMPACT study in MASH in December 2025. The data showed that pemvidutide delivered significant improvements across key measures in patients with MASH. The company plans to initiate a global phase III registrational PERFORMA study to evaluate the safety and efficacy of pemvidutide in MASH patients with moderate-to-severe liver fibrosis in the second half of 2026, with 52-week data expected in 2029. Top-line data from the mid-stage RECLAIM study evaluating pemvidutide for the treatment of patients with AUD is expected in the third quarter of 2026. Enrollment was completed ahead of schedule in November 2025. Altimmune is also developing the candidate in the phase II RESTORE study in patients with ALD. Patient enrollment is expected to be completed by the third quarter of 2026. ALT's Zacks Rank & Other Stocks to ConsiderAltimmune currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Amarin Corporation (AMRN - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have narrowed from $5.50 to $4.64. AMRN shares have risen 7.6% year to date. Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 50.02%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 6.9% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $1.94 from $1.50. Over the same period, EPS estimates for 2027 have risen to $3.80 from $2.91. LQDA shares have gained 67% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-22 13:15
2mo ago
|
Here's Why You Should Add Altimmune Stock to Your Portfolio Now | FMP Stock News | |
|
Original source text
Key Takeaways Altimmune plans to launch a global phase III MASH study for pemvidutide in 2H 2026.ALT reported phase IIb data showing MASH resolution and fibrosis improvement through 48 weeks.Altimmune expects top-line AUD study data in Q3 2026 and is advancing a phase II ALD study. Altimmune (ALT - Free Report) , a late clinical-stage biotech, is focused on developing therapies for liver diseases. Its lead pipeline candidate, pemvidutide, is a balanced 1:1 glucagon/GLP-1 dual receptor agonist and has a differentiated mechanism of action with a “pipeline in a product” potential for the treatment of liver diseases. Altimmune is positioning itself as a differentiated player with the potential to compete in large commercial indications such as metabolic dysfunction-associated steatohepatitis ("MASH"), alcohol use disorder ("AUD") and alcohol-associated liver disease ("ALD").Year to date, shares of Altimmune have lost 18.9% compared with the industry’s 6.5% decline. Image Source: Zacks Investment Research Strong Momentum in the Multi-Billion-Dollar MASH MarketAn important catalyst supporting investor enthusiasm is Altimmune’s expanding opportunity in the MASH market. The disease represents a multi-billion-dollar commercial opportunity with limited approved treatment options. The recent data from the phase IIb IMPACT study evaluating pemvidutide in MASH patients demonstrated statistically significant MASH resolution without worsening of fibrosis at 24 weeks, sustained through 48 weeks. It also showed clear signs of reducing liver scarring by 48 weeks. Key markers of liver damage and inflammation continued to improve over time, showing steady progress with the added benefit of weight loss. The candidate’s relatively simple dosing profile may also support better patient adherence compared with more complex injectable regimens. Altimmune recently announced alignment with the FDA on key parameters for a late-stage MASH program and plans to initiate a global phase III registrational PERFORMA study in the second half of 2026. The study will evaluate pemvidutide in MASH patients with moderate-to-severe fibrosis, with 52-week data expected in 2029. Pemvidutide’s Expansion Beyond MASHBeyond MASH, Altimmune is also evaluating pemvidutide in separate mid-stage studies for alcohol-related diseases like AUD and ALD. Top-line data from the mid-stage RECLAIM study evaluating pemvidutide for the treatment of patients with AUD is expected in the third quarter of 2026. Enrollment was completed ahead of schedule in November 2025. Altimmune is also developing the candidate in the phase II RESTORE study in patients with ALD. Patient enrollment is expected to be completed by the third quarter of 2026. The candidate holds Fast Track designations for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. ALT's Zacks Rank & EstimatesAltimmune currently carries a Zacks Rank #2 (Buy). Over the past 30 days, estimates for ALT’s 2026 and 2027 loss per share have narrowed from $1.00 to 69 cents and from $1.00 to 73 cents, respectively. Other Stocks to ConsiderSome other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR's shares have lost 13.5% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV's shares have risen 4.4% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA's shares have gained 79.6% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-22 14:00
2mo ago
|
FDA Grants Accelerated Approval to Gilead's Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV) | FMP Stock News | |
|
Original source text
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States.The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Improvement in disease-related clinical outcomes has not been established. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial. Chronic HDV is considered the most severe form of viral hepatitis and is associated with a markedly higher risk of rapid disease progression, liver failure, and mortality compared with HBV alone. In the United States, studies in general populations have estimated that HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people. “Hepatitis delta virus is associated with rapid progression of liver disease and a high risk of serious or even life-threatening liver-related complications,” said Dr. Ira Jacobson, MD, Department of Medicine at NYU Grossman School of Medicine. “For patients, an HDV diagnosis means managing two distinct viral liver diseases—hepatitis B and hepatitis D—each contributing to disease progression, monitoring demands, and treatment complexities. The approval of Hepcludex for chronic HDV represents a critical advancement, introducing a long-awaited option that begins to address a significant unmet medical need and has the potential to meaningfully alter the course of this devastating disease for people living with HDV in the United States.” MYR301 (NCT03852719) evaluated the efficacy and safety of Hepcludex in adults with chronic HDV, with treatment administered for up to 144 weeks followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint at Week 48, with continued treatment, demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure. “The approval of Hepcludex represents a historic milestone for people living with HDV in the United States, marking the first FDA-approved treatment for HDV,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need. With Hepcludex, we now have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV for patients in the U.S.” U.S. Access and Hepcludex Approval Across Markets The Gilead Support Path® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments. Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA) and other countries globally to treat people living with chronic HDV. Please see below for U.S. Indication and Important Safety Information for Hepcludex. U.S. Indication for Hepcludex Hepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). U.S. Important Safety Information for Hepcludex IMPORTANT SAFETY INFORMATION BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. Warnings and Precautions Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment. Adverse Reactions Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus. Dosage and Administration Dosage in adults: 8.5 mg once daily administered by subcutaneous injection HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown. In all patients, manage the underlying HBV infection as clinically appropriate. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition. About Hepcludex (bulevirtide) Hepcludex (bulevirtide) is a first-in-class entry inhibitor for the treatment of adults living with chronic hepatitis delta virus (HDV) infection. Chronic HDV infection is a serious liver disease that occurs only as a co-infection in individuals with chronic HBV and is associated with rapid disease progression, liver failure, and increased mortality. Hepcludex is supplied as a vial for once-daily subcutaneous injection. Each vial contains an 8.5 mg dose when prepared according to the Instructions for Use within FDA-approved labeling. Hepcludex works by blocking the entry of both HDV and HBV into liver cells, addressing a key step in the viral lifecycle. The FDA’s accelerated approval of Hepcludex is supported by data from the Phase 3 MYR301 study demonstrating that Hepcludex was an effective and generally well-tolerated treatment option, with durable efficacy observed through long-term treatment of up to 144 weeks. Hepcludex is supplied as a once-daily injectable therapy and represents the first and only treatment option for people living with HDV that received FDA accelerated approval in the United States, addressing a long-standing unmet medical need for this historically underserved patient community. As part of the FDA accelerated approval, Gilead has committed to a confirmatory long-term outcomes study, which has already been initiated in people living with chronic HDV. Continued approval may be contingent upon verification of clinical benefit. About HDV Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have HBV. It is estimated that at least 12 million people worldwide are currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis and hepatic decompensation and an increased risk of liver cancer and death. In the U.S., it is estimated that there are ~40,000-80,000 people living with HDV. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving bulevirtide; uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for Hepcludex, and the risk that any such approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the risk that physicians may not see the benefits of prescribing Hepcludex for the treatment of HDV; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Hepcludex is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260522569258/en/ |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-27 08:00
1mo ago
|
New IMPACT Phase 2b Data Highlight Concurrent Improvements Across Multiple Non-Invasive Markers and qFibrosis-Measured Fibrosis Regression with Pemvidutide in MASH at EASL 2026 | FMP Stock News | |
|
Original source text
May 27, 2026 08:00 ET | Source: Altimmune, IncConcurrent improvement across key non-invasive tests underscores convergence of pemvidutide effects on MASH disease activity and fibrosis AI-based digital pathology analyses further demonstrate antifibrotic effects of pemvidutide at 24 weeks GAITHERSBURG, Md., May 27, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that new analyses of data from the IMPACT Phase 2b trial demonstrated that treatment with pemvidutide, an investigational, balanced 1:1 glucagon/GLP-1 dual receptor agonist, is associated with concurrent improvements across multiple non-invasive tests (NITs) of metabolic dysfunction-associated steatohepatitis (MASH) activity and fibrosis. These new data reinforce a consistent and clinically meaningful treatment effect observed at just 24 weeks. These findings are based on analyses of overlapping markers of liver fat, inflammation and fibrosis. The analyses are further supported by separate AI-based digital pathology data showing significant improvements in fibrosis stage by HistoIndex qFibrosis® at 24 weeks, providing potent evidence of the antifibrotic potential of pemvidutide. The data are being presented today and Friday in poster sessions, including a late-breaking poster presentation, at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. “The ability of pemvidutide to demonstrate concurrent improvements across multiple non-invasive markers – and to see those findings supported by histologic measures of fibrosis – provides a more comprehensive and clinically meaningful view of its potential beneficial effect in patients with MASH,” said Naim Alkhouri, MD, Chief Medical Officer, Summit Clinical Research. “These results point to the potential ability of pemvidutide to address multiple dimensions of disease biology, including fibrosis, and support its potential to target key drivers of MASH.” Highlights of the data presented at EASL 2026 include: Pemvidutide treatment resulted in significant increases in the percentage of patients achieving concurrent improvements across key NITs compared with placebo at 24 weeks – including in liver fat content (LFC), alanine aminotransferase (ALT), liver stiffness measurement (LSM) and enhanced liver fibrosis (ELF).37.8% of patients taking pemvidutide 1.2 mg and 22.7% of patients taking pemvidutide 1.8 mg achieved concurrent >0.5 ELF reduction plus >30% LSM reduction compared with 8.3% of patients taking placebo (p=0.0002 and p=0.02, respectively). These overlapping NIT responses provide a more stringent and clinically meaningful assessment of treatment effect and also evidence of improvement across multiple dimensions of disease biology. The findings are further supported by AI-based digital pathology analyses using qFibrosis, which utilizes advanced Second Harmonic Generation (SHG)/Two-Photon Excitation Fluorescence (TPEF) imaging to quantify fibrosis across the entire biopsy sample, enabling detection of continuous and intra-stage changes in fibrosis. Those results showed: Pemvidutide treatment led to significant reductions in continuous fibrosis values versus placebo.68.6% of patients taking pemvidutide 1.2 mg and 54.5% of patients taking pemvidutide 1.8 mg achieved ≥1 stage qFibrosis regression compared with 29.6% of patients taking placebo (p<0.001 and p=0.002, respectively) after 24 weeks of treatment. “The consistency of these findings across non-invasive markers and advanced imaging approaches reflects the potential early impact of pemvidutide in addressing MASH,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “These multiple consistent analyses strengthen our confidence in pemvidutide and its potential to address significant unmet needs among patients living with MASH. In addition, 48-week data demonstrating a clear dose effect at the 1.8 mg dose further reinforces our confidence in the robustness and durability of the clinical response. Based on these promising Phase 2b clinical data, we are excited to begin patient enrollment in our PERFORMA Phase 3 trial of pemvidutide in patients with MASH in the second half of this year.” About the IMPACT Phase 2b Study The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks. About Pemvidutide Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The RECLAIM Phase 2 trial in AUD completed enrollment in November 2025 and topline data are expected in third quarter 2026. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the second half of 2026. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Forward-Looking Statements Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing RECLAIM and RESTORE trials and planned PERFORMA Phase 3 trial, the timing of key milestones for the Company’s clinical programs, including the anticipated launch of the PERFORMA Phase 3 trial in MASH, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-27 08:30
1mo ago
|
Altimmune to Participate in Upcoming Investor Conferences | FMP Stock News | |
|
Original source text
May 27, 2026 08:30 ET | Source: Altimmune, IncGAITHERSBURG, Md., May 27, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that management will participate in the following upcoming investor conferences: 2026 Jefferies Global Healthcare Conference Thursday, June 4, 2026 Fireside chat at 12:50 p.m. ET New York, NY Goldman Sachs 47th Annual Global Healthcare Conference Wednesday, June 10, 2026 Fireside chat at 8:00 a.m. ET Miami Beach, FL A webcast of the fireside chats will be available via the Events section of the Altimmune website. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead investigational candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-28 11:00
1mo ago
|
Pemvidutide Demonstrates Significant Metabolic Improvements in Patients with MASH in New 48‑Week IMPACT Phase 2b Data Presented at EASL 2026 | FMP Stock News | |
|
Original source text
May 28, 2026 11:00 ET | Source: Altimmune, Inc“Best of EASL” oral presentation highlights meaningful reductions in triglycerides, cholesterol, and blood pressure, along with improvements in key metabolic risk factors PERFORMA Phase 3 trial to further evaluate the broad metabolic and liver-related effects of pemvidutide GAITHERSBURG, Md., May 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that new 48-week data from the IMPACT Phase 2b trial show that pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, significantly reduced elevated lipids while improving multiple cardiometabolic risk factors in patients with metabolic dysfunction-associated steatohepatitis (MASH). The findings demonstrated reductions in triglycerides and total cholesterol, along with improvements in weight, waist circumference and blood pressure, highlighting the broad impact of pemvidutide on key drivers of MASH. The data were presented for the first time at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. “MASH therapies that can address both liver disease and its underlying metabolic drivers are urgently needed to improve outcomes for patients,” said Mazen Noureddin, M.D., IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital, and Chief Scientific Officer and Co-Chairman of Summit Clinical Research. “These 48-week IMPACT trial findings are particularly compelling because they demonstrate meaningful reductions in liver fat and fibrosis biomarkers, and in lipids elevated at baseline, alongside improvements in weight and other cardiometabolic risk factors. In patients with MASH, where cardiovascular disease remains a leading cause of mortality, seeing this type of broad metabolic impact is highly relevant to overall patient outcomes." Highlights of the 48-week data presented at EASL 2026 include: Pemvidutide 1.8 mg treatment resulted in significant reductions in serum lipid levels among patients with elevated baseline values versus placebo, including: Triglycerides reductions of -23.7%Total cholesterol reductions of -15.4% In addition to lipids, pemvidutide 1.8 mg treatment resulted in significant improvements in other metabolic risk factors versus placebo: Weight loss of 7.5%, continuing throughout treatment with no plateauingReductions in body mass index of -3.0 kg/m2Reductions in waist circumference (a measure of visceral adiposity that is associated with increased cardiovascular risk) of -5.3 cmImprovements in systolic blood pressure of -4.0 mmHg and diastolic blood pressure of -2.2 mmHg Results also showed that the safety profile of pemvidutide was maintained at 48 weeks, and the tolerability profile was generally favorable without dose titration. Approximately 1% of total patients receiving pemvidutide discontinued treatment due to adverse events (AEs). The majority of AEs were mild to moderate, and no imbalances in cardiac AEs were observed with pemvidutide versus placebo. Most gastrointestinal AEs were mild to moderate in severity and predominantly occurred within the first 8 weeks. Previously reported IMPACT Phase 2b trial results showed the proportion of patients achieving both a ≥0.5 reduction in Enhanced Liver Fibrosis (ELF) and a ≥30% reduction in Liver Stiffness Measurement (LSM) at week 48 was 3.2% with placebo, compared with 27.8% for pemvidutide 1.2 mg (p<0.001) and 32.4% for pemvidutide 1.8 mg (p<0.0001). “These new 48-week results highlight the breadth of the impact of pemvidutide across some of the most critical cardiometabolic risk factors, including lipids, weight and blood pressure,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “Across multiple analyses, we are seeing consistent data that reinforce our confidence in the unique mechanism of pemvidutide – a balanced 1:1 ratio of glucagon and GLP-1 – and its potential to address significant unmet needs in this patient population. Given the promising findings from the IMPACT Phase 2b trial, we are eager to initiate our PERFORMA Phase 3 trial later this year to further assess the efficacy and safety of pemvidutide in patients with MASH.” About the IMPACT Phase 2b Study The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks. About Pemvidutide Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The RECLAIM Phase 2 trial in AUD completed enrollment in November 2025 and topline data are expected in third quarter 2026. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the second half of 2026. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Forward-Looking Statements Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the completed IMPACT and planned PERFORMA Phase 3 trials, the timing of key milestones for the Company’s clinical programs, including the anticipated launch of the PERFORMA Phase 3 trial in MASH, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-30 12:00
1mo ago
|
Mirum Pharmaceuticals Announces New Data from Rare Liver Disease Programs Presented at the EASL International Liver Congress 2026 | FMP Stock News | |
|
Original source text
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced new data from its rare liver disease programs. Late-breaking results from the Phase 2b VISTAS study of volixibat in PSC and Phase 2b AZURE-1 study of brelovitug in HDV, alongside data featuring its established therapy, LIVMARLI® (maralixibat), in PFIC, were presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2026.“The results from the VISTAS and Phase 2b AZURE-1 studies represent meaningful progress toward bringing potential new therapies to patients living with PSC and HDV, two serious rare liver diseases with limited treatment options,” said Chris Peetz, Chief Executive Officer at Mirum. “The presented VISTAS results position us well for our planned NDA submission for volixibat later this year, and we are encouraged by the growing body of evidence supporting the long-term use of LIVMARLI in PFIC.” VISTAS Study Results: Treatment with Volixibat in Patients with PSC Demonstrates Rapid, Sustained, and Clinically Meaningful Reductions in Pruritus Treatment with volixibat resulted in the following changes from baseline in patients with moderate-to-severe pruritus at baseline: A 2.72-point reduction and a 1.64-point (p<0.0001) placebo-adjusted reduction in the primary endpoint of cholestatic pruritus, as measured by the Adult Itch Reported Outcome (ItchRO) scale, 56% of patients achieving a ≥2 point reduction in pruritus compared with only 26% of patients on placebo (p=0.0019) and 37% of patients achieving a ≥3 point reduction in pruritus compared with only 11% of patients on placebo (p=0.0011), A mean reduction in serum bile acid (sBA) levels of 33.7 µmol/L compared with a 2.1 µmol/L increase with placebo, for a placebo-adjusted difference of −35.8 µmol/L (p=0.0324), and Trends toward improvement in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep and fatigue scores (sleep: placebo-adjusted difference of −5.69; p=0.0011; fatigue: placebo-adjusted difference of −2.33; p=0.1322). Volixibat’s safety profile was generally consistent with the known effects of IBAT inhibition. Gastrointestinal adverse events and elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin were observed more frequently in volixibat-treated patients than placebo-treated patients. “PSC remains a difficult disease to manage, particularly for patients experiencing pruritus, which can significantly impact quality of life,” said Cynthia Levy, M.D., FAASLD, AGAF, Professor of Clinical Medicine at the University of Miami Miller School of Medicine. “The magnitude and consistency of the pruritus improvements observed in VISTAS are encouraging and support the potential of volixibat as a treatment option for pruritus in patients with PSC.” Mirum has a pre-New Drug Application (NDA) meeting for volixibat in PSC scheduled with the U.S. FDA in summer 2026, with a planned NDA submission in the second half of 2026. Phase 2b AZURE-1 Study Results: Treatment with Brelovitug Demonstrates Efficacy and Safety in Patients with HDV, Including Those with Advanced Disease Baseline characteristics reflected a population with advanced disease, including cirrhosis in 53% of patients, elevated ALT levels (mean [SD], 124 [95] U/L), with 21% of patients having ALT ≥5 times the upper limit of normal (ULN), elevated liver stiffness (mean [SD], 16.6 [10.5] kPa), including 15% with liver stiffness ≥25 kPa. At Week 24, treatment with brelovitug resulted in virologic response (≥2 log10 reduction in HDV RNA from baseline or undetectable HDV RNA [ The primary composite endpoint of virologic response and ALT normalization at Week 24 was achieved in 45% and 35% of patients in the 300 mg QW and 900 mg Q4W arms, respectively, versus 0% in the delayed treatment arm. Reductions in liver stiffness as measured by transient elastography were observed in both brelovitug treatment arms at Week 24, with reductions from baseline of 3.6 kPa in the 300 mg QW arm and 2 kPa in the 900 mg Q4W arm, compared to an increase of 1.1 kPa in the delayed treatment arm. Treatment with brelovitug was well tolerated across dose groups, with injection-site reaction (all reported as mild [Grade 1]) being the most common treatment-related adverse event. Low rates of flu-like symptoms were observed. These results build upon prior data to support the potential of brelovitug as a well-tolerated single-agent therapy to treat HDV, including in patients with advanced disease. Topline data from the Phase 3 AZURE-1 and AZURE-4 studies are expected in the second half of 2026, with potential BLA submission and commercial launch in the U.S. in 2027. Treatment with LIVMARLI® (maralixibat) Demonstrates Improved Event-Free Survival (EFS) in Patients with PFIC Compared with a Real-World PFIC Cohort from the NAPPED Database This analysis compared time to first clinical event between PFIC patients aged ≥1 year with non-truncating BSEP deficiency and FIC1 variants treated with LIVMARLI (maralixibat) for up to 4.8 years (n=41) and an external control cohort from the NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion (NAPPED) database (n=256). Events were defined as: surgical biliary diversion (SBD), liver transplantation, or death. The LIVMARLI (maralixibat)-treated cohort showed significant improvement in overall EFS (HR=0.29; 95% CI 0.16-0.54; p=0.0001) as well as in EFS for SBD (HR=0.05 (95% CI 0.01-0.39), p=0.0036) and for liver transplantation or death (HR=0.44 (95% CI 0.22-0.88), p=0.02), respectively. The results of this analysis add to the body of evidence supporting the long-term use of LIVMARLI (maralixibat) in patients with PFIC. About LIVMARLI® (maralixibat) oral solution and tablets LIVMARLI® (maralixibat) is an orally administered, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for two pediatric cholestatic liver diseases. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. three months of age and older and in Europe for patients two months of age and older. It is also approved in the U.S. for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older. For more information for U.S. residents, please visit LIVMARLI.com. LIVMARLI has received orphan designation for ALGS and PFIC. LIVMARLI is currently being evaluated in the Phase 3 EXPAND study in additional settings of cholestatic pruritus. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirum’s clinical trials section on the company’s website. IMPORTANT SAFETY INFORMATION Limitation of Use: LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein. LIVMARLI can cause side effects, including Liver injury. Changes in certain liver tests are common in patients with ALGS and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal. Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you. A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects. [url="]US Prescribing Information [/url] [url="]EU SmPC [/url] Canadian Product Monograph About Volixibat Volixibat is an investigational oral, minimally absorbed agent designed to selectively inhibit the ileal bile acid transporter (IBAT). Volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking the recycling of bile acids through inhibition of IBAT, thereby reducing bile acids systemically and in the liver. Volixibat is currently being evaluated in Phase 2b studies for primary sclerosing cholangitis (PSC) (VISTAS study), and primary biliary cholangitis (PBC) (VANTAGE study). In 2026, Mirum shared that the Phase 2b VISTAS study of volixibat in PSC met its primary endpoint, with statistically significant and clinically meaningful reductions in pruritus observed in patients treated with volixibat. Volixibat’s safety profile in the study was generally consistent with the known effects of IBAT inhibition. In 2024, Mirum announced positive interim results from the Phase 2b VANTAGE study of volixibat in PBC. No new safety signals were observed in the study. Volixibat has been granted FDA Breakthrough Therapy designation for the treatment of PBC. About Brelovitug Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis delta virus (HDV) and the hepatitis B virus (HBV). Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles. Brelovitug has FDA Breakthrough Therapy designation for the treatment of chronic HDV infection and PRIME and Orphan designations from the European Medicines Agency. In 2026, Mirum announced that in the Phase 2b portion of the AZURE-1 study in HDV, treatment with brelovitug demonstrated strong antiviral activity in HDV and achieved the primary composite endpoint of virologic response and alanine aminotransferase (ALT) normalization at Week 24 in both brelovitug dose arms as compared to the delayed treatment arm. Favorable safety and tolerability profiles were observed. Brelovitug is currently being evaluated in the global Phase 3 AZURE clinical program. Mirum owns worldwide rights to brelovitug. About Mirum Pharmaceuticals Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX). Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS). Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company’s planned participation at a scientific congress, Mirum’s continued or advancing leadership in PSC, HDV, and PFIC, the potential benefit of Mirum products and candidates in real world settings versus scientific presentations of data at the EASL Congress 2026, as well as the potential regulatory success of any Mirum development candidates based on such data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-31 09:00
1mo ago
|
Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with early-stage RET fusion-positive lung cancer | FMP Stock News | |
|
Original source text
Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with ea |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-04 23:10
1mo ago
|
Altimmune Touts Pemvidutide Momentum Ahead of Phase 3 MASH Trial | FMP Stock News | |
|
Original source text
MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT executives said the company is preparing to begin enrolling patients in the second half of the year for a Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis, or MASH, while also awaiting data from related alcohol-associated liver disease programs.Speaking at the Jefferies 2026 Global Healthcare Conference, Chief Executive Officer Jerry Durso said Altimmune is in the startup phase of its Phase 3 MASH program and expects patient enrollment to begin later this year. He also pointed to recently presented data at the European Association for the Study of the Liver, or EASL, meeting as strengthening the company’s view of pemvidutide’s potential differentiation in MASH. Get Altimmune alerts: How Altimmune Could Grab a Big Chunk of the GLP-1 Market“It is an exciting year for Altimmune,” Durso said, adding that the company is continuing to build its understanding of what pemvidutide could bring to the MASH population as the market becomes more competitive. Company Highlights EASL Data and Fibrosis Analyses Altimmune’s chief medical officer, Christophe, said the company had a significant presence at EASL and received a “best of EASL” abstract designation for an oral presentation on 48-week data. He said Altimmune also presented data on cardiovascular risk, non-invasive testing and qFibrosis, a second harmonic generation-based analysis of biopsy samples. This Small Cap Wealth Management Stock Could Provide Big ReturnsChristophe said several methods of evaluating fibrosis were directionally consistent, including biological markers such as PRO-C3 and CTX, PathAI’s LiverExplore approach and qFibrosis. “All these different approaches were consistently showing that anti-fibrotic effect of pemvidutide,” he said. He noted that standard histological reading of biopsies can vary among pathologists, especially at 24 weeks, and said Altimmune designed its Phase 3 trial with a 52-week biopsy-based interim analysis partly to address that variability. He said the company’s 48-week Phase 2 data showed a “very strong anti-fibrotic effect.” Phase 3 Trial to Use Biopsy and Non-Invasive Tools Christophe said Altimmune has regulatory alignment with the U.S. Food and Drug Administration and European regulators on the Phase 3 protocol. He said the trial will use MASH assist, an artificial intelligence-supported tool that helps pathologists read digital biopsy images, while pathologists retain final judgment. Altimmune also plans to include qFibrosis as a secondary endpoint in the Phase 3 trial. Christophe emphasized that qFibrosis is not an approved primary endpoint, but said it could complement biopsy-based primary endpoint assessments. The Phase 3 study will include patients with F2 and F3 fibrosis. Christophe said Cohort 1 will include about 990 biopsy-proven F2 and F3 patients and will support the accelerated approval efficacy assessment. A second cohort will be based more heavily on non-invasive tests, or NITs, while also contributing to the safety database needed for accelerated approval. Durso said Altimmune will collect non-invasive test data for all patients, which could position the company to respond if regulators eventually allow NIT-based endpoints in MASH. “We would need the agency to move their position,” Durso said. Executives Emphasize Differentiation in MASH Market Asked about pemvidutide’s potential positioning if approved, Durso said differentiation will be central as more MASH therapies enter the market. He said pemvidutide’s dual mechanism, combining weight loss effects with direct liver activity, could be important for selected patient segments. Durso said GLP-1 monotherapies may become a common first-line option by the time pemvidutide could reach the market, but he argued that durability of treatment and tolerability could be key differentiators. He said in Altimmune’s Phase 2 trial, discontinuation on the 1.8 mg dose was lower than placebo. He also pointed to potential use in patients at risk of sarcopenia and said pemvidutide may fit in the “middle of the treatment cascade,” while other approaches could be used in different patient groups. Durso said the EASL meeting reinforced the company’s view that the balance between glucagon and GLP-1 activity matters. He said Altimmune believes pemvidutide’s balanced ratio and its EuPort domain may contribute to a differentiated tolerability and efficacy profile. Balance Sheet Supports MASH Readout Timeline Chief Financial Officer Greg Weaver said Altimmune has raised capital through two equity offerings this year, including $75 million in January and a more recent $225 million offering. He said the company’s balance sheet is now “north of $500 million.” Weaver said that funding is expected to cover the company’s runway through delivery of MASH results in 2029, while also supporting Phase 2 trials in alcohol use disorder, or AUD, and alcohol-associated liver disease, or ALD. “Going forward, we would focus on non-dilutive options as our preferred go-forward plan,” Weaver said, noting possible strategic investments, debt facility use or an at-the-market program as additional sources of flexibility. AUD and ALD Data Remain Upcoming Catalysts Durso said the company is also looking forward to data from its AUD and ALD programs, calling them an expansion of pemvidutide’s potential into areas of high unmet need. He said AUD data are expected in the third quarter, with ALD enrollment expected to be completed in the third quarter as well. Christophe said pemvidutide may be relevant in AUD and ALD because its GLP-1 activity could address reward and alcohol cravings, while its glucagon activity may address liver-related effects. He said the AUD study will evaluate heavy drinking days, and the company powered the trial around a one-day difference between pemvidutide and placebo. He said the study will also use blood markers, including phosphatidylethanol, or PEth, and will evaluate other endpoints such as days of no drinking and World Health Organization drinking level changes. Durso said Altimmune expects to issue a traditional topline data release for the AUD study in the third quarter. If the data are positive, he said the company would seek interaction with regulators and update its plans. “The company stays extremely focused,” Durso said. “We are in an era of execution.” About Altimmune NASDAQ: ALTAltimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions. Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose. 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 Altimmune Right Now?Before you consider Altimmune, 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 Altimmune wasn't on the list. While Altimmune currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. View The Five Stocks Here Thinking about investing in Meta, Roblox, or Unity? Click the link to learn what streetwise investors need to know about the metaverse and public markets before making an investment. Get This Free Report |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-08 12:55
1mo ago
|
Is Altimmune Worth Buying Ahead of 2026 Catalysts? | FMP Stock News | |
|
Original source text
Key Takeaways ALT expects a Phase III MASH study launch in 2026 and RECLAIM alcohol-use-disorder data in Q3.ALT reported phase IIb results showing sustained MASH resolution and fibrosis-related improvements.ALT ended April 2026 with about $535 million pro forma cash, supporting operations into 2029. Altimmune (ALT - Free Report) is heading into 2026 with a catalyst-heavy calendar tied to pemvidutide, its lead clinical asset. The setup is straightforward: investors are underwriting pivotal execution in metabolic dysfunction-associated steatohepatitis and looking for proof-of-concept in alcohol-related disease programs.That concentration can create outsized upside on good news and sharp downside on missteps. ALT’s Near-Term Setup Centers on Two 2026 EventsThe first key milestone is the planned start of a global phase III registrational study in metabolic dysfunction-associated steatohepatitis in the second half of 2026, targeting patients with moderate-to-severe liver fibrosis. Management expects 52-week data in 2029, but the 2026 start is the gating event that moves pemvidutide into a pivotal setting. The second 2026 catalyst is top-line phase II data from the RECLAIM study in alcohol use disorder, expected in the third quarter of 2026. Enrollment for RECLAIM was completed in November 2025, ahead of schedule, which keeps the timeline intact heading into next year. A third marker investors may watch is enrollment progress in the RESTORE phase II study in alcohol-associated liver disease. Enrollment is expected to be completed by the third quarter of 2026, providing another read on execution even before efficacy data is available. Altimmune’s MASH Thesis Depends on Pivotal ExecutionThe phase III PERFORMA start matters because it is the step that turns phase II signals into a program designed for registration. Altimmune has highlighted alignment with the Food and Drug Administration on key late-stage parameters, which helps reduce design uncertainty as the company moves into PERFORMA. The stakes are high because the company’s value proposition is heavily tied to pemvidutide across multiple indications. That dependence cuts both ways: success can validate a “pipeline in a product” narrative, while failure in a pivotal metabolic dysfunction-associated steatohepatitis program would likely be a major downside catalyst given how central pemvidutide is to the investment case. That binary profile is also why 2026 is so important. Even without clinical readouts from PERFORMA in 2026, simply initiating the study on time can support confidence that the timeline toward 2029 data remains credible. ALT’s Phase II Evidence Investors Are Leaning OnIn the phase IIb IMPACT study, pemvidutide delivered statistically significant metabolic dysfunction-associated steatohepatitis resolution without worsening fibrosis at 24 weeks, and that response was sustained through 48 weeks. The company also pointed to clear signs of reducing liver scarring by 48 weeks, alongside continued improvement in markers of liver damage and inflammation. Top-line 48-week results highlighted statistically significant reductions versus placebo in non-invasive markers of liver fibrosis, including Enhanced Liver Fibrosis and liver stiffness, with improvements that deepened from the 24-week mark. The dataset also included metabolic benefits, reductions in liver fat and inflammation markers, and meaningful weight loss. Notably, the higher-dose group (1.8 mg) showed weight reduction through 48 weeks without plateauing, while tolerability remained favorable with low discontinuation rates and no serious treatment-related adverse events reported. Altimmune’s Cash Runway Into 2029 Lowers Timing RiskAltimmune’s financial position improved into the first quarter of 2026, with cash, cash equivalents and short-term investments of $332 million as of March 31, 2026 versus $274 million as of Dec. 31, 2025. The company raised $75 million in a registered direct offering and $8 million via an at-the-market program in January to February 2026 and then completed an oversubscribed public offering in April 2026 with $225 million in gross proceeds. Pro forma cash was roughly $535 million as of April 30, 2026. Management expects that cash runway to support operations into 2029, which can lower timing risk by reducing near-term funding pressure as the company advances phase III plans in metabolic dysfunction-associated steatohepatitis and continues its phase II alcohol use disorder and alcohol-associated liver disease trials. ALT’s Dilution and Financing Overhang Still ExistsEven with a strengthened balance sheet, Altimmune remains a pre-revenue clinical-stage biotech with no marketed products, which keeps external financing central to its operating model. That reality can translate into dilution risk over time. The company has indicated it may still raise additional funds if market conditions are favorable, a reminder that opportunistic capital raises can remain part of the story even with a longer runway. Altimmune’s Competition Checklist for BuyersCompetition is a key constraint on upside across all three target areas. In metabolic dysfunction-associated steatohepatitis, pemvidutide faces a crowded field spanning GLP-1 drugs and combination incretins, FGF-21 therapies, thyroid hormone receptor beta agonists, and other emerging mechanisms. Major competitors include Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , alongside metabolic dysfunction-associated steatohepatitis-focused developers such as Madrigal Pharmaceuticals (MDGL - Free Report) and Viking Therapeutics (VKTX). In alcohol-associated liver disease, large pharmaceutical companies are pursuing multiple approaches, including FGF-21, GLP-1 and RNA-based programs. In alcohol use disorder, pemvidutide would compete with approved options like Vivitrol as well as generic therapies including naltrexone and acamprosate. The net effect is that even strong data may not automatically translate into clear commercial leadership. ALT’s Valuation Snapshot and What It ImpliesOn a relative basis, the stock has been framed through trailing 12-month book value per share. ALT recently traded at 1.24 times trailing book value, compared with 1.39 times for the Zacks sub-industry, 3.71 times for the Zacks sector, and 8.01 times for the S&P 500. Over the past five years, the book value multiple has ranged from 0.71 times to 5.25 times, with a five-year median of 2.34 times. That context suggests the current multiple sits below the longer-term midpoint, but still within a historical band. The stated $3 price target approach is tied to a 1.4 times trailing 12-month book value multiple. In practical terms, that framework implies expectations for performance that tracks more “in-line” outcomes than a high-conviction upside scenario, placing even more emphasis on 2026 execution as the driver of sentiment. Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-08 13:11
1mo ago
|
ALT and the Rise of Dual Agonists Targeting Liver Disease | FMP Stock News | |
|
Original source text
Key Takeaways ALT positions pemvidutide as a dual glucagon/GLP-1 therapy targeting multiple liver-disease pathways.ALT reported sustained MASH resolution and fibrosis-marker improvements through 48 weeks.ALT expects a Phase III MASH start and AUD phase II data in 2026, with ALD enrollment progressing. Altimmune (ALT - Free Report) is trying to ride a clear shift in liver drug development. Programs are increasingly designed to hit multiple pathways at once, rather than relying on a single lever like weight loss alone. For Altimmune that approach centers on pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist positioned as a “pipeline in a product” across several liver-related settings.The next year matters because it puts this strategy into real-world execution. With pivotal planning in MASH and readouts approaching in alcohol-related conditions, 2026 will help determine whether multi-mechanism liver therapies can translate into durable, clinically meaningful outcomes. ALT’s Thesis Fits a Shift Toward Multi-Pathway TherapiesLiver diseases such as metabolic dysfunction-associated steatohepatitis (MASH) are not single-driver problems. They involve fat accumulation, inflammatory signaling, and progressive fibrosis. That biology has pushed drug development toward combinations and multi-mechanism assets, including dual and even triple agonist designs. Pemvidutide is Altimmune’s entry into this shift. The company’s core claim is that balanced glucagon plus GLP-1 activity in one molecule can address liver biology directly while also improving metabolic factors that contribute to disease progression. Altimmune’s Differentiation Claim vs GLP-1 AloneAltimmune’s differentiation argument starts with the liver’s central role in glucagon signaling. In its framing, glucagon works directly on the liver and may help reduce liver fat, inflammation, and scarring. GLP-1, by contrast, is primarily tied to appetite reduction and weight loss, with potential anti-inflammatory benefits as well. The point is not that GLP-1-driven weight loss is irrelevant. Instead, Altimmune is positioning glucagon activity as additive, aiming to push beyond weight loss alone and more directly influence hepatic fat and fibrosis-related pathways that matter for long-term disease modification. ALT’s Data That Supports “Differentiated” PositioningThe company’s 48-week phase IIb MASH dataset is the backbone of that positioning. Pemvidutide showed statistically significant MASH resolution without worsening of fibrosis at 24 weeks, and the effect was sustained through 48 weeks. More importantly for the “differentiated” narrative, multiple non-invasive markers associated with fibrosis and liver stiffness improved versus placebo, and the benefits deepened from 24 to 48 weeks, which Altimmune frames as evidence of sustained antifibrotic activity over time. Safety and tolerability were also described as favorable, with low discontinuation rates and no serious treatment-related adverse events reported. The higher 1.8 mg dose group continued to lose weight through 48 weeks without plateauing, supporting a profile that could keep improving with longer treatment. Altimmune’s 2026 Milestones as Trend Validation PointsThe next major test is the planned global phase III registrational PERFORMA study in MASH patients with moderate-to-severe liver fibrosis. Altimmune expects to initiate the study in the second half of 2026, following alignment with the FDA on key parameters for late-stage development. In parallel, pemvidutide is being evaluated in alcohol use disorder (AUD), with top-line phase II data from the RECLAIM study expected in the third quarter of 2026. Enrollment was completed in November 2025, ahead of schedule, which reduces one common source of timeline slippage. If these milestones land cleanly, they would reinforce investor interest in dual-agonist liver programs that can credibly claim multi-pathway impact, not just metabolic improvements. ALT’s Alcohol-Related Disease Expansion Could Broaden the StoryAltimmune is also building a second leg to the story in alcohol-related conditions. The company is running a phase II program in alcohol-associated liver disease (ALD) as well as the phase II AUD trial, framing both as areas of significant unmet need with commercial potential. Operationally, the ALD RESTORE phase II study began in July 2025, and enrollment is expected to be completed by the third quarter of 2026. Together with the AUD readout, these programs support the “pipeline in a product” strategy by extending the same mechanism into adjacent, liver-relevant indications. Altimmune’s Partnering Takeover Angle in a Crowded FieldThe competitive landscape is crowded. In MASH, Altimmune is up against GLP-1 leaders such as Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , as well as a wide range of mechanisms and combination strategies from large pharma and MASH-focused players. NVO and LLY currently carry a Zacks Rank #3 (Hold). Against that backdrop, the company is framed as an attractive licensing or takeover candidate if it keeps executing and the differentiated profile holds up in larger studies. The counterweight is concentration risk: Altimmune remains heavily dependent on pemvidutide, and a phase III failure in MASH would be a major blow. ALT’s Key Watch Items for Trend InvestorsFor investors following the growing shift toward multi-pathway liver therapies, several key milestones will be important to watch. These include the timing of Phase III initiation and the outcome of FDA interactions as Altimmune finalizes the PERFORMA study design. Investors will also be focused on enrollment progress across ongoing trials, including the completion of ALD enrollment and the timely release of top-line data from the AUD study. Another area of attention is manufacturing preparedness, as Altimmune has already secured clinical supply and expects its production process to be scalable to support potential global Phase III needs. Finally, the competitive landscape remains an important consideration, particularly as rapidly advancing GLP-1 combination therapies and other novel mechanisms could narrow pemvidutide’s differentiation and increase the standard required to support best-in-class positioning.Bottom of Form In a field where narrative advantage can disappear quickly, execution and durability of effect will decide whether ALT’s dual-agonist thesis becomes a template or just another crowded contender. Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-08 13:11
1mo ago
|
ALT Stock Guide to Pemvidutide's MASH, AUD and ALD Setup | FMP Stock News | |
|
Original source text
Key Takeaways ALT's pemvidutide showed significant MASH resolution in phase IIb, sustained through 48 weeks.ALT plans to start the global Phase III PERFORMA study in the second half of 2026.ALT expects 2026 phase II data in alcohol use disorder and alcohol-associated liver disease. Altimmune (ALT - Free Report) is building its investment case around a single clinical asset with multiple shots on goal in liver disease. Pemvidutide sits at the center of that thesis, with mid-stage data in metabolic dysfunction-associated steatohepatitis and active studies in alcohol-related conditions.For investors, the story is simple: execution on the next wave of clinical milestones, paired with enough capital to reach them, can define the stock’s setup into 2026 and beyond. ALT’s Liver Disease Focus and Why It MattersAltimmune is a late clinical-stage biotechnology company focused on therapies for liver diseases. The company is incorporated in Delaware and headquartered in Gaithersburg, MD. It has not generated product sales revenue to date. Operations have been funded through equity, debt and grants, leaving the business reliant on external capital while it advances clinical development. That funding model matters because the value of the equity is closely tied to clinical progress, particularly progress tied to pemvidutide. With revenues still minimal and inconsistent, the stock can be sensitive to trial outcomes and timelines. Altimmune’s Pemvidutide Is a “Pipeline in a Product”Pemvidutide is Altimmune’s lead candidate and the company’s core value driver. It is being developed across three serious liver-related indications: metabolic dysfunction-associated steatohepatitis, alcohol use disorder, and alcohol-associated liver disease. Management has positioned pemvidutide as a “pipeline in a product” because the same molecule is intended to address multiple disease settings that share metabolic and hepatic injury pathways. The company has also indicated it may evaluate additional indications that leverage pemvidutide’s profile. This concentration creates leverage both ways. A successful pivotal program in metabolic dysfunction-associated steatohepatitis can expand strategic options, including partnering interest, but the company is also heavily dependent on one drug. ALT’s Dual Glucagon and GLP-1 Design in Plain EnglishPemvidutide is designed as a balanced 1:1 dual agonist that activates both glucagon and glucagon-like peptide-1 receptors. Altimmune’s thesis is that combining these two pathways in a single molecule can improve liver and metabolic outcomes more broadly than a single-pathway approach. In plain terms, glucagon activity is intended to work directly on the liver and may help reduce liver fat, inflammation, and scarring. The glucagon-like peptide-1 component is intended to support weight loss by reducing appetite, with potential anti-inflammatory benefits as well. Altimmune believes that pairing these effects can address multiple aspects of liver disease at once, while also driving weight loss that can matter clinically for patients with metabolic dysfunction-associated steatohepatitis. Altimmune’s EuPort Tech and Tolerability AnglePemvidutide uses Altimmune’s proprietary EuPort technology, which is designed to slow how the drug is absorbed. The company’s rationale is that slower absorption may improve tolerability. Altimmune has highlighted the potential for reduced gastrointestinal side effects, a common challenge with therapies that act on glucagon-like peptide-1 biology. Better tolerability can support persistence on therapy, which can be important for longer-duration liver endpoints. The company has also pointed to simple dosing as a potential adherence advantage versus more complex injectable regimens, which could matter if pemvidutide moves into larger, global trials. ALT’s MASH Data Readout and the Phase III PathIn its phase IIb IMPACT study, pemvidutide achieved statistically significant metabolic dysfunction-associated steatohepatitis resolution without worsening of fibrosis at 24 weeks, and the response was sustained through 48 weeks. By 48 weeks, Altimmune reported signs consistent with antifibrotic activity, alongside continued improvement in markers tied to liver damage and inflammation, with the added benefit of weight loss. Altimmune has stated it reached alignment with the Food and Drug Administration on key parameters for a late-stage study. The company expects to initiate the global phase III registrational PERFORMA study in the second half of 2026, with 52-week data anticipated in 2029. Altimmune’s AUD and ALD Catalysts for 2026Beyond metabolic dysfunction-associated steatohepatitis, pemvidutide is being evaluated in separate phase II programs in alcohol-related disease, which Altimmune views as significant unmet-need markets. For alcohol use disorder, the RECLAIM phase II study completed enrollment in November 2025. Altimmune expects top-line data in the third quarter of 2026, setting up a clear catalyst window next year. For alcohol-associated liver disease, the RESTORE phase II study began in July 2025, and enrollment is expected to be completed by the third quarter of 2026. Together, these readouts broaden the 2026 news flow beyond the metabolic dysfunction-associated steatohepatitis pivotal setup. ALT’s Regulatory Tailwinds and What They SignalThe Food and Drug Administration granted Fast Track designation to pemvidutide for metabolic dysfunction-associated steatohepatitis and alcohol use disorder, and Breakthrough Therapy Designation for metabolic dysfunction-associated steatohepatitis. These designations generally reflect the seriousness of the conditions and the unmet medical need, while also signaling that regulators see enough potential benefit to support development efficiency. They do not remove execution risk, but they can help keep timelines clearer as trials scale. Competition remains intense, including large players such as Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , both currently carrying Zacks Rank #3 (Hold). For ALT, the near-term focus is whether pemvidutide’s multi-indication strategy translates into durable, registrational-quality outcomes across liver disease. Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-10 09:05
1mo ago
|
Altimmune Sets Pemvidutide's Phase 3 MASH Playbook as AUD Data Near | FMP Stock News | |
|
Original source text
MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT management used an appearance at the Goldman Sachs Global Healthcare Conference to outline the company’s focus on pemvidutide, its lead metabolic and liver disease drug candidate, and to discuss the planned Phase 3 program in metabolic dysfunction-associated steatohepatitis, or MASH.Jerry Durso, Altimmune’s president, CEO and chairman, said pemvidutide was the primary reason he joined the company, first as a board member last year and then as CEO at the beginning of this year. Durso said the drug’s combination of GLP-1 activity and glucagon activity made it “uniquely suited for liver disease,” with the GLP component targeting metabolic factors such as weight loss and the glucagon component providing what he described as direct activity on the liver. Get Altimmune alerts: How Altimmune Could Grab a Big Chunk of the GLP-1 MarketDurso also highlighted pemvidutide’s proprietary EuPort domain, which he said could be an important contributor to tolerability. He said Altimmune’s current strategy emphasizes liver disease as the primary focus for the asset. Management Highlights Strategic Priorities Durso said Altimmune’s priorities over the past year have included strengthening the company’s management team, preparing for late-stage development, refining how it communicates pemvidutide’s potential differentiation and positioning the company financially for a Phase 3 program. This Small Cap Wealth Management Stock Could Provide Big ReturnsGreg Weaver, Altimmune’s CFO, said the company has raised “approaching $500 million” over the past 18 months. He noted that MASH trials can cost in the range of $400 million and said Altimmune is now “well-positioned” with additional optionality if needed. Weaver also said investor engagement and clearer messaging around Altimmune’s focus on MASH and liver disease have been important as the company prepares for its next stage of development. Pemvidutide’s Role in a Developing MASH Market Durso said the MASH treatment market is maturing, with the first approved therapies now available and more mechanisms expected to enter the market. He said the disease’s complexity likely means multiple mechanisms and combinations will be needed over time. Durso said Altimmune is thinking about where pemvidutide could fit in a future market with more treatment options, rather than only the current market. He pointed to potential patient segments including those who may have difficulty tolerating other therapies, patients at risk of sarcopenia and patients who may benefit from a simpler titration schedule. He also said pemvidutide could become a potential combination partner because of what the company believes could be a favorable safety and tolerability profile, along with a simple titration approach. Phase 2 Data and Differentiation Durso reviewed prior Phase 2 MASH results, saying pemvidutide showed early activity on MASH resolution at 24 weeks. While the company did not see statistical significance on fibrosis by biopsy at 24 weeks, Durso said non-invasive tests suggested antifibrotic activity was already emerging. At 48 weeks, he said Altimmune saw improvement across non-invasive tests, including FibroScan and ELF, and that the company believes 52 weeks is the appropriate time point for a biopsy-based fibrosis readout in Phase 3. Durso noted there was no biopsy at 48 weeks in the Phase 2 program. Durso also highlighted adherence and tolerability, saying pemvidutide had an “extremely low discontinuation rate” in the 48-week data and that more patients stayed on the 1.8 milligram dose than on placebo. He compared that with Phase 2 MASH data for survodutide, saying that program had a discontinuation rate above 20%. Durso said pemvidutide has a one-to-one ratio of glucagon and GLP-1 agonism, while survodutide is more weighted toward GLP-1 activity. He said the ratio, the molecule itself and the EuPort domain may all be relevant to tolerability and differentiation within the glucagon/GLP-1 class. Phase 3 MASH Trial Plans Altimmune’s planned Phase 3 MASH program will include a 52-week interim histology readout that Durso said could support an accelerated approval filing, along with a longer-term outcomes component. The study will evaluate two doses of pemvidutide: 1.8 milligrams and 2.4 milligrams. Durso said the 1.8 milligram dose is supported by the Phase 2 data, while the 2.4 milligram dose offers potential upside on efficacy and in certain subpopulations. The Phase 3 trial will include a simple one- or two-step titration over four or eight weeks, depending on dose. The study will include biopsy-proven F2 and F3 MASH patients, as well as a separate cohort of NIT-screened F2 and F3 patients. Durso said the biopsy cohort will support the 52-week efficacy analysis, while both cohorts together will contribute to the safety database and longer-term outcomes analysis. Durso said the trial will be the first Phase 3 program to use the AIM-MASH AI Assist tool, which is intended to support pathologists in histology reads and reduce variability. He said Altimmune continues to guide for patient enrollment to begin in the second half of the year, with a readout anticipated in 2029. He said MASH trials typically take 18 to 24 months to enroll, and Altimmune is targeting the lower end of that range. Alcohol Use Disorder and Alcohol-Associated Liver Disease Durso also discussed pemvidutide’s development in alcohol use disorder, or AUD, and alcohol-associated liver disease, or ALD. He said Altimmune sees a rationale for the drug in these areas because it may address both drinking behavior through GLP-1-related effects on craving and liver-related effects through its glucagon activity. The company expects Phase 2 data in AUD next quarter. Durso said the primary endpoint is a reduction in the number of heavy drinking days, with additional measures including liver enzymes, weight and secondary endpoints such as World Health Organization classification. Durso said there are about 12 million people with AUD and roughly half that number with ALD, with no approved drugs in ALD and only older options in AUD. Weaver said that if Phase 3 development in AUD or ALD is supported by the data, Altimmune would likely prefer non-dilutive financing options, which could include a partner, strategic transaction or regional arrangement. About Altimmune NASDAQ: ALTAltimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions. Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose. 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 Altimmune Right Now?Before you consider Altimmune, 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 Altimmune wasn't on the list. While Altimmune currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. View The Five Stocks Here The AI boom is creating opportunities across semiconductors, cloud computing, enterprise software, infrastructure, cybersecurity, and automation. Inside this report, you’ll find 10 companies positioned to benefit as artificial intelligence moves from hype to real-world deployment and becomes a core growth driver for corporate America. Get This Free Report |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-10 10:32
1mo ago
|
Altimmune, Inc. (ALT) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript | FMP Stock News | |
|
Original source text
Altimmune, Inc. (ALT) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-04-04 04:08
3mo ago
|
Structure Therapeutics Inc. Sponsored ADR (NASDAQ:GPCR) Given Consensus Rating of “Moderate Buy” by Brokerages | FMP Stock News | |
|
Original source text
Posted by Defense World Staff on Apr 4th, 2026Shares of Structure Therapeutics Inc. Sponsored ADR (NASDAQ:GPCR – Get Free Report) have been given a consensus recommendation of “Moderate Buy” by the eighteen research firms that are currently covering the firm, Marketbeat Ratings reports. Two equities research analysts have rated the stock with a sell rating, one has issued a hold rating, thirteen have issued a buy rating and two have assigned a strong buy rating to the company. The average twelve-month target price among analysts that have issued ratings on the stock in the last year is $110.00. Several brokerages recently weighed in on GPCR. The Goldman Sachs Group upgraded Structure Therapeutics to a “strong-buy” rating in a research report on Tuesday, January 20th. Guggenheim upped their price target on Structure Therapeutics from $90.00 to $140.00 and gave the company a “buy” rating in a research note on Tuesday, January 20th. BMO Capital Markets set a $145.00 price target on Structure Therapeutics and gave the stock an “outperform” rating in a report on Tuesday, March 17th. HC Wainwright cut their price objective on Structure Therapeutics from $114.00 to $100.00 and set a “buy” rating for the company in a research report on Monday, March 16th. Finally, Citigroup reaffirmed an “outperform” rating on shares of Structure Therapeutics in a research report on Friday, December 12th. Get Our Latest Stock Analysis on Structure Therapeutics Structure Therapeutics Stock Performance Shares of GPCR stock opened at $53.48 on Friday. Structure Therapeutics has a twelve month low of $13.22 and a twelve month high of $94.90. The stock has a market cap of $3.79 billion, a price-to-earnings ratio of -67.70 and a beta of -1.17. The company’s 50-day moving average price is $64.67 and its 200-day moving average price is $52.40. Structure Therapeutics (NASDAQ:GPCR – Get Free Report) last posted its earnings results on Thursday, February 26th. The company reported ($0.49) earnings per share for the quarter, missing the consensus estimate of ($0.35) by ($0.14). As a group, equities research analysts predict that Structure Therapeutics will post -0.82 EPS for the current year. Hedge Funds Weigh In On Structure Therapeutics Several large investors have recently made changes to their positions in the stock. CWM LLC lifted its stake in Structure Therapeutics by 35.2% during the fourth quarter. CWM LLC now owns 480 shares of the company’s stock worth $33,000 after purchasing an additional 125 shares in the last quarter. HighTower Advisors LLC raised its holdings in shares of Structure Therapeutics by 3.6% in the 4th quarter. HighTower Advisors LLC now owns 9,320 shares of the company’s stock valued at $648,000 after buying an additional 320 shares during the period. State of Wyoming raised its holdings in shares of Structure Therapeutics by 29.7% in the 4th quarter. State of Wyoming now owns 1,761 shares of the company’s stock valued at $122,000 after buying an additional 403 shares during the period. PNC Financial Services Group Inc. lifted its stake in Structure Therapeutics by 9.4% during the 3rd quarter. PNC Financial Services Group Inc. now owns 4,828 shares of the company’s stock worth $135,000 after acquiring an additional 413 shares in the last quarter. Finally, China Universal Asset Management Co. Ltd. boosted its holdings in Structure Therapeutics by 4.3% during the 4th quarter. China Universal Asset Management Co. Ltd. now owns 10,888 shares of the company’s stock valued at $757,000 after acquiring an additional 444 shares during the period. 91.78% of the stock is currently owned by institutional investors and hedge funds. About Structure Therapeutics (Get Free Report) Structure Therapeutics (NASDAQ:GPCR) is a clinical‐stage biotechnology company focused on the discovery and development of oral small‐molecule therapies that target G protein‐coupled receptors (GPCRs). Leveraging advances in structural biology, computational chemistry and medicinal chemistry, the company’s scientific platform is designed to optimize binding interactions and pharmacokinetic properties, with the goal of delivering innovative treatments for metabolic and inflammatory disorders. The company’s pipeline comprises multiple programs in various stages of preclinical and clinical development. Read More Five stocks we like better than Structure Therapeutics Receive News & Ratings for Structure Therapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Structure Therapeutics and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINEDHT Holdings, Inc. (NYSE:DHT) Receives Average Rating of “Moderate Buy” from Analysts NEXT HEADLINE »American National Bank & Trust Has $2.71 Million Stock Holdings in Duke Energy Corporation $DUK |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-04-06 04:43
3mo ago
|
Capricorn Fund Managers Ltd Invests $17.57 Million in Structure Therapeutics Inc. Sponsored ADR $GPCR | FMP Stock News | |
|
Original source text
Posted by Defense World Staff on Apr 6th, 2026Capricorn Fund Managers Ltd bought a new stake in shares of Structure Therapeutics Inc. Sponsored ADR (NASDAQ:GPCR – Free Report) during the fourth quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The fund bought 252,600 shares of the company’s stock, valued at approximately $17,568,000. Structure Therapeutics makes up about 4.2% of Capricorn Fund Managers Ltd’s investment portfolio, making the stock its 3rd largest holding. Capricorn Fund Managers Ltd owned approximately 0.42% of Structure Therapeutics as of its most recent SEC filing. Other institutional investors also recently bought and sold shares of the company. E. Ohman J or Asset Management AB bought a new stake in Structure Therapeutics during the 4th quarter valued at approximately $314,000. Gilbert & Cook Inc. bought a new position in shares of Structure Therapeutics in the 4th quarter worth approximately $395,000. JPMorgan Chase & Co. raised its position in shares of Structure Therapeutics by 37.0% in the 3rd quarter. JPMorgan Chase & Co. now owns 58,148 shares of the company’s stock worth $1,628,000 after acquiring an additional 15,706 shares in the last quarter. Alyeska Investment Group L.P. purchased a new position in shares of Structure Therapeutics in the 3rd quarter valued at approximately $6,856,000. Finally, Paradigm Biocapital Advisors LP bought a new stake in shares of Structure Therapeutics during the third quarter valued at approximately $10,440,000. 91.78% of the stock is owned by institutional investors. Structure Therapeutics Stock Performance Shares of GPCR stock opened at $53.48 on Monday. The company has a market capitalization of $3.79 billion, a price-to-earnings ratio of -67.70 and a beta of -1.17. Structure Therapeutics Inc. Sponsored ADR has a one year low of $13.22 and a one year high of $94.90. The company’s 50-day moving average is $64.67 and its 200 day moving average is $52.83. Structure Therapeutics (NASDAQ:GPCR – Get Free Report) last issued its earnings results on Thursday, February 26th. The company reported ($0.49) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.35) by ($0.14). As a group, research analysts predict that Structure Therapeutics Inc. Sponsored ADR will post -0.82 earnings per share for the current fiscal year. Analysts Set New Price Targets Several brokerages recently weighed in on GPCR. JPMorgan Chase & Co. upped their price target on Structure Therapeutics from $65.00 to $105.00 and gave the stock an “overweight” rating in a research note on Thursday, January 22nd. Guggenheim boosted their target price on shares of Structure Therapeutics from $90.00 to $140.00 and gave the company a “buy” rating in a report on Tuesday, January 20th. The Goldman Sachs Group raised shares of Structure Therapeutics to a “strong-buy” rating in a research report on Tuesday, January 20th. Weiss Ratings reiterated a “sell (d-)” rating on shares of Structure Therapeutics in a research note on Thursday, January 22nd. Finally, Jefferies Financial Group set a $125.00 price target on shares of Structure Therapeutics and gave the company a “buy” rating in a research report on Thursday, December 11th. Two equities research analysts have rated the stock with a Strong Buy rating, thirteen have given a Buy rating, one has assigned a Hold rating and two have given a Sell rating to the company. According to MarketBeat.com, Structure Therapeutics currently has a consensus rating of “Moderate Buy” and an average target price of $110.00. Read Our Latest Stock Report on Structure Therapeutics About Structure Therapeutics (Free Report) Structure Therapeutics (NASDAQ:GPCR) is a clinical‐stage biotechnology company focused on the discovery and development of oral small‐molecule therapies that target G protein‐coupled receptors (GPCRs). Leveraging advances in structural biology, computational chemistry and medicinal chemistry, the company’s scientific platform is designed to optimize binding interactions and pharmacokinetic properties, with the goal of delivering innovative treatments for metabolic and inflammatory disorders. The company’s pipeline comprises multiple programs in various stages of preclinical and clinical development. Further Reading Five stocks we like better than Structure Therapeutics Receive News & Ratings for Structure Therapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Structure Therapeutics and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINECapricorn Fund Managers Ltd Buys 247,000 Shares of Roivant Sciences Ltd. $ROIV NEXT HEADLINE »Guardant Health, Inc. $GH is Capricorn Fund Managers Ltd’s 6th Largest Position |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-04-08 16:14
3mo ago
|
Structure Therapeutics: The Oral Obesity Inflection, Best-In-Class Efficacy Meets Biased-Agonism Safety Moat | FMP Stock News | |
|
Original source text
Structure Therapeutics (GPCR) is initiated with a BUY rating and $110 price target, reflecting a 101% upside from current levels. Aleniglipron, GPCR's oral GLP-1 agonist, demonstrated 16.3% placebo-adjusted weight loss at 44 weeks with superior safety and manufacturing cost advantages. GPCR's $1.4B cash position provides runway through 2028 and a valuation floor of $23.10 in a bear scenario. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-04-14 16:05
3mo ago
|
Structure Therapeutics Appoints Matthew Lang, J.D. as Chief Operating Officer and General Counsel | FMP Stock News | |
|
Original source text
SAN FRANCISCO, April 14, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced the appointment of Matthew Lang, J.D. as Chief Operating Officer and General Counsel. Mr. Lang joins Structure Therapeutics with more than fifteen years of executive leadership experience across global biopharmaceutical organizations, with deep expertise spanning legal, corporate strategy, compliance, risk management, and business development.“Matt is a proven leader with a strong track record of guiding organizations through growth and transformation,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “His experience across global operations, strategic transactions, and commercialization will be critical as we move aleniglipron into Phase 3 and continue to build a world-class leadership team.” Mr. Lang most recently served as Chief Legal Officer and Secretary at Metsera, Inc., helping to guide the company through its up to $10 billion acquisition by Pfizer. Prior to Metsera, Mr. Lang served as Chief Business and Legal Officer at Lyell Immunopharma, Inc., and held several executive officer positions at Myovant Sciences, where he helped lead the company through Phase 3 clinical development, global approval and commercialization of Myfembree® and Orgovyx®. Mr. Lang also served as the Managing Director and General Manager of Myovant’s European operations in Basel Switzerland where he was responsible for all aspects of Myovant’s ex-US business operations. Earlier in his career Mr. Lang held roles of increasing seniority at Gilead Sciences, Inc., and was an attorney at Dechert, LLP. He received his B.A. in Classical Studies from Queen’s University at Kingston, Canada and his J.D. from the University of Pennsylvania Law School. “I am excited to join Structure Therapeutics at this important stage as we move into Phase 3 development with one of the most promising late-stage assets in the competitive obesity landscape,” said Mr. Lang. “The Company’s mission and differentiated portfolio represent a compelling opportunity to deliver a complete pipeline of meaningful therapies to patients. I look forward to working with the team to further strengthen the Company’s operational foundation, execute on strategic priorities, and drive long-term value.” About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; and any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron and any other of the Company’s investigational compounds. In addition, when or if used in this press release, the words and phrases “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies; the Company’s ability to advance aleniglipron, ACCG-2671, ACCG-3535, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company’s therapeutic candidates; competitive products or approaches limiting the commercial value of the Company’s product candidates; the Company’s ability to fund development activities and achieve development goals; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Annual Report on Form 10-K and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-04-17 11:20
3mo ago
|
3 Ways to Invest in the Growing GLP-1 Weight Loss Market | FMP Stock News | |
|
Original source text
Weight loss drugs are big business, with the GLP-1 receptor agonist market expected to nearly triple in size to $185 billion by 2033, a compound annual growth rate of about 12.4%. Although increasingly a global medical phenomenon, the bulk of the market still exists in the United States, and domestic investors can get in on the action by targeting companies that manufacture these powerful drugs.It's a mistake to assume that all sales of GLP-1 drugs will be limited to the major products Ozempic or Wegovy, both manufactured by pharma giant Novo Nordisk A/S NYSE: NVO. The demand in this relatively new space is so great that a growing number of alternatives are quickly emerging, despite the seeming dominance of a few major players. Below, we'll look at a standalone, lesser-known biotech developer with a promising alternative in the works, as well as two exchange-traded funds (ETFs) that can give broad and diversified exposure to the whole industry at once. Get OZEM alerts: A Pivot Toward GLP-1 Drugs Could Be Transformational for Structure TherapeuticsStructure Therapeutics NASDAQ: GPCR is a biotechnology company developing drugs focused on G protein-coupled receptors, or GPCRs. The firm has traditionally targeted new treatments for metabolic and inflammatory diseases like fibrosis or nonalcoholic steatohepatitis. Structure Therapeutics Today GPCR Structure Therapeutics $43.30 +1.77 (+4.26%) As of 06/11/2026 04:00 PM Eastern 52-Week Range$15.80▼ $94.90Price Target$106.75 The company has more recently followed the trend toward GLP-1 drugs as well, and its aleniglipron has recently demonstrated 16.3% weight loss, adjusted for certain trial factors, and could beat out some competitors in terms of safety and manufacturing costs. Though Structure is not currently profitable, it does have a solid cash position of about $1.4 billion. This should give it ample runway over the next several quarters as it continues to develop aleniglipron, with the drug candidate moving toward a critical Phase 3 trial. Analysts have flagged Structure for its strong potential based on the promise of aleniglipron. Ratings for GPCR stock include 15 out of 18 ratings of Buy or equivalent. Shares have been hit fairly hard so far this year, declining by 20% in the midst of a challenging set of external factors, but bullishness still wins the day across Wall Street: with a consensus price target of $110, Structure's share price could more than double. The First GLP-1 Agonist ETF Is Building a Track Record of SuccessInvestors should know that there is massive potential in the GLP-1 space thanks to the recent proliferation of ETFs dedicated to this investment strategy. The Roundhill GLP-1 & Weight Loss ETF NASDAQ: OZEM was an early leader in this space, launching in mid-2024. The fund takes a fairly focused approach, targeting about two dozen pharmaceutical companies positioned to benefit from the growth of the GLP-1 agonist industry. Roundhill GLP-1 & Weight Loss ETF Today OZEM Roundhill GLP-1 & Weight Loss ETF $30.85 +0.96 (+3.21%) As of 06/11/2026 03:56 PM Eastern 52-Week Range$23.22▼ $37.15Assets Under Management$47.37 million Novo Nordisk and major rival Eli Lilly & Co. NYSE: LLY feature prominently, accounting for nearly 30% of the portfolio in total. The fund's basket is fairly broad, though, and includes a number of domestic and international names to provide substantial geographical diversification. Crucially, the fund provides exposure not only to large companies involved in producing or selling GLP-1 therapeutics, but also to those creating other weight loss enablers and even to companies supporting the supply chain vital to production. As an actively managed fund, OZEM has an expense ratio of 0.59%; this may be high in comparison with ETFs overall but is actually quite competitive relative to other active funds. The fund is quite niche, so it has a modest asset base of some $52 million and relatively low trading volumes. Still, it is up an impressive 45% in the last year, rewarding those investors willing to buy and hold. A modest dividend serves as an added bonus. Another GLP-1 ETF With a Passive ApproachAn alternative in the GLP-1 ETF space is the Amplify Weight Loss Drug & Treatment ETF NYSEARCA: THNR. In many ways THNR is quite similar to OZEM: this fund also carries an annual fee of 0.59% and tracks roughly two dozen pharma names connected to the GLP-1 agonist market. It also weighs Novo Nordisk and Eli Lilly heavily, although these two companies combine to make up just around a quarter of the portfolio, so there is a bit more room in the case of THNR for access to other companies. Amplify Weight Loss Drug & Treatment ETF Today THNR Amplify Weight Loss Drug & Treatment ETF $24.53 +0.54 (+2.25%) As of 06/11/2026 04:10 PM Eastern 52-Week Range$21.70▼ $27.28Assets Under Management$4.08 million A big difference, though, is that THNR is not an actively managed fund. Rather, it tracks an index of companies in the GLP-1 industry. Its weighting is determined by float-adjusted market cap, and its portfolio is influenced by factors such as market cap weighting and trading volume. While the basket is rebalanced just four times a year, some investors may find that this passive reflection of the market is more suitable for their interests than an active management approach. On the other hand, THNR's asset base is tiny, at just $4 million, and its trading volume matches. The fund has returned about 30% in the last year—still roughly on par with the broader market, but well below OZEM. Should You Invest $1,000 in Roundhill GLP-1 & Weight Loss ETF Right Now?Before you consider Roundhill GLP-1 & Weight Loss ETF, 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 Roundhill GLP-1 & Weight Loss ETF wasn't on the list. While Roundhill GLP-1 & Weight Loss ETF currently has a Hold rating among analysts, top-rated analysts believe these five stocks are better buys. View The Five Stocks Here Click the link to see MarketBeat's guide to investing in 5G and which 5G stocks show the most promise. Get This Free Report |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-04-27 16:05
2mo ago
|
Structure Therapeutics to Present Aleniglipron, Amylin and Combination Data at the American Diabetes Association 86th Scientific Sessions | FMP Stock News | |
|
Original source text
SAN FRANCISCO, April 27, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced multiple presentations at the American Diabetes Association (ADA) 86th Scientific Sessions, taking place June 5–8, 2026 in New Orleans, Louisiana. The presentations include an oral presentation on the ACCESS Phase 2b clinical trial of aleniglipron.Details of the presentations are as follows: Title: ACCESS Trial: Dose-Ranging Evaluation of Aleniglipron, an Oral Small Molecule Nonpeptide GLP-1RA, Demonstrates Meaningful Weight Reductions in People Living with Obesity and Overweight Session: Oral Presentations - Human Studies in Obesity Treatment: Emerging Therapeutic Options and Strategies for Decision-Making (1032-OR) Speaker: Julio Rosenstock, MD, University of Texas Southwestern Medical Center Date: Friday, June 5 Time: 12:45 p.m. – 1:00 p.m. CT Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial Session: General Poster Session (2637-P) Date: Monday, June 8 Time: 12:30 p.m. – 1:30 p.m. CT Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials Session: Late Breaking Poster Session (3101-LB) Date: Sunday, June 7 Time: 12:30 p.m. – 1:30 p.m. CT Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs Session: Late Breaking Poster Session (3061-LB) Date: Sunday, June 7 Time: 12:30 p.m. – 1:30 p.m. CT Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists Session: Late Breaking Poster Session (3062-LB) Date: Sunday, June 7 Time: 12:30 p.m. – 1:30 p.m. CT Additional information about the ADA 2026 Scientific Sessions is available at the ADA meeting website (American Diabetes Association). About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: Structure’s expectations around presenting clinical and preclinical data at the ADA meeting, the Company’s future plans and prospects; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron and any other of the Company’s investigational compounds. In addition, when or if used in this press release, the words and phrases “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies; the Company’s ability to advance its clinical and preclinical candidates; the Company’s ability to fund development activities and achieve development goals; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Annual Report on Form 10-K and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-07 16:05
2mo ago
|
Structure Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights | FMP Stock News | |
|
Original source text
Reported positive results from aleniglipron Phase 2 ACCESS II study with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs Data from ACCESS OLE expected in Q3 2026; Data from the Body Composition and Type 2 Diabetes/Obesity data expected in Q4 2026 Positive end-of-Phase 2 feedback received from FDA; aleniglipron Phase 3 initiation on track for Q3 2026 Initial data from Phase 1 single ascending dose (SAD) study of oral small molecule amylin receptor agonist ACCG-2671 and initiation of multiple ascending dose (MAD) study expected in Q3 2026; Phase 1 initiation of second oral amylin candidate ACCG-3535 expected in Q4 2026 Aleniglipron, amylin and combination data to be presented at the American Diabetes Association (ADA) 86th Scientific Sessions in June 2026 Cash, cash equivalents and short-term investments of $1.5 billion as of March 31, 2026, expected to provide cash runway through the end of 2028 SAN FRANCISCO, May 07, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “With positive end of Phase 2 feedback received from the FDA for aleniglipron, we are well positioned to start our Phase 3 registrational program for chronic weight management in the third quarter,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “We are also looking forward to our aleniglipron presentation along with presentations on our oral amylin and GLP-1 combination program at the upcoming ADA meeting. With our Phase 1 clinical data for our oral amylin candidate ACCG-2671 anticipated in the third quarter and additional aleniglipron data later this year, our broad portfolio positions us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment, and fixed dose oral combinations for specific patient populations and expanded indications.” Recent and Upcoming Milestones Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight In March 2026, the Company reported data from the aleniglipron clinical program included 44-week topline data from the Phase 2 ACCESS II study, as well as interim data from body composition study and Phase 2b ACCESS open label extension (OLE) study. The Phase 2 ACCESS II study demonstrated a placebo-adjusted mean weight loss of 16.3% (39 Ibs; p<0.0001) at the 180 mg dose and 16.0% (37 Ibs; p<0.0001) at the 240 mg dose at 44 weeks.The ongoing ACCESS OLE study achieved continued weight loss up to 16.2% (40.5 lbs) observed with 120 mg dose at 56 weeks.No weight loss plateau was observed in any of the studies. Data from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies provide a strong foundation for the decision to advance aleniglipron into Phase 3 clinical development. The Company expects to report topline results from the ACCESS OLE and Body Composition studies in Q3 and Q4 2026, respectively. The Company received positive end-of-Phase 2 feedback from the U.S. Food and Drug Administration (FDA) and clear guidance on the Phase 3 program with a starting titration dose of 2.5 mg and the intent to evaluate multiple doses. The Company anticipates initiating the Phase 3 program in Q3 2026. The Company is also conducting supplementary studies to enhance the competitive profile of aleniglipron, including: Ongoing study of ACCESS OLE to evaluate the tolerability profile of the dosing regimen starting at the 2.5 mg dose for those previously on placebo and to collect up to 72 weeks of data exposure to aleniglipron, including 180 mg dose. Data are expected in Q3 2026.Ongoing Body Composition study to assess the effect of aleniglipron on body fat loss over a 44-week evaluation period, which includes a 28-week titration period and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. These data will be used to inform the size of a sub study into the Phase 3 program. Data are expected in Q4 2026.Ongoing 30-week study in patients with type 2 diabetes mellitus (T2DM) with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron to evaluate the potential for including participants with T2DM in the Phase 3 obesity program. Data are expected in Q4 2026.Ongoing SWITCH study to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. Data are expected in Q4 2026. Oral Small Molecule Amylin Receptor Agonists In December 2025, the Company advanced ACCG-2671 into a Phase 1 clinical study as the industry’s most advanced oral small molecule amylin therapy for the treatment of obesity. ACCG-2671 is being evaluated in an ongoing single ascending dose (SAD) study to measure safety, tolerability, pharmacokinetics, and food-effect of single ascending doses in healthy adult participants with data anticipated in 2H 2026. In addition, the Company expects to initiate a multiple ascending dose (MAD) study in Q3 2026.In November 2025, the Company declared a second oral small molecule dual amylin calcitonin receptor agonist development candidate, ACCG-3535. ACCG-3535, which is a unique chemical structure compared to ACCG-2671, demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats. Combination therapy with semaglutide (both concurrently and as a subsequent add-on to semaglutide) resulted in superior weight loss compared to semaglutide or ACCG-3535 monotherapy. The Company expects to initiate a Phase 1 clinical study of ACCG-3535 in Q4 2026. Multiple presentations at ADA, taking place from June 5–8, 2026 Details of the presentations are as follows: Title: ACCESS Trial: Dose-Ranging Evaluation of Aleniglipron, an Oral Small Molecule Nonpeptide GLP-1RA, Demonstrates Meaningful Weight Reductions in People Living with Obesity and Overweight Session: Oral Presentations - Human Studies in Obesity Treatment: Emerging Therapeutic Options and Strategies for Decision-Making (1032-OR) Speaker: Julio Rosenstock, MD, University of Texas Southwestern Medical Center Date: Friday, June 5: 12:45 p.m. – 1:00 p.m. CT Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial Session: General Poster Session (2637-P) Date: Monday, June 8: 12:30 p.m. – 1:30 p.m. CT Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials Session: Late Breaking Poster Session (3101-LB) Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs Session: Late Breaking Poster Session (3061-LB) Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists Session: Late Breaking Poster Session (3062-LB) Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT Additional information about the ADA 2026 Scientific Sessions is available at the ADA meeting website (American Diabetes Association). First Quarter 2026 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $1.5 billion as of March 31, 2026. The Company received $100.0 million in the first quarter of 2026, consisting of an upfront license fee for certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, the supplementary studies, and Phase 3 registrational studies in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $66.5 million, as compared to $42.9 million for the same period in 2025. The increase in R&D expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses and employee expenses (primarily due to an increase in personnel) to support the advancement of our GLP-1R franchise including aleniglipron. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $22.9 million, as compared to $13.4 million for the same period in 2025. The increase in G&A expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations and professional services. Net Loss: Net loss for the first quarter of 2026 totaled $76.0 million, with non-cash share-based compensation expense of $11.6 million, compared to $46.8 million for the same period in 2025 with non-cash share-based compensation expense of $5.9 million. About Aleniglipron and Structure Therapeutics’ Oral Metabolic Franchise Aleniglipron (GSBR-1290) is an investigational orally-available, small molecule agonist of the GLP-1 receptor, a validated drug target for the treatment of obesity and T2DM. Through Structure Therapeutics’ structure-based drug discovery platform, aleniglipron was designed to be a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway. Beyond aleniglipron, Structure Therapeutics is developing next generation oral small molecules including amylin receptor agonists (ACCG-2671 and ACCG-3535), and other combination GLP-1 receptor agonists candidates targeting the glucose-dependent insulinotropic polypeptide (GIP), glucagon and apelin receptors. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of ACCESS OLE and Body Composition studies data readouts; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; the expected timing of initial data from the Phase 1 study of ACCG-2671; the planned initiation of the ACCG-3535 Phase 1 study and the timing thereof; the belief that data to date from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies support and inform aleniglipron advancement into Phase 3 clinical development; the Company’s anticipated cash runway and uses of cash; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases "anticipated," "believe," "expect," "potential," "to be," "will," and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company's forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company's planned Phase 3 clinical program and other clinical studies; disruptions to the operations of the FDA or other U.S. governmental agencies or comparable foreign regulatory authorities caused by funding shortages, leadership changes, or staffing reductions; the Company's ability to advance aleniglipron, ACCG-2671, LTSE-2578, ACCG-3535, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company's therapeutic candidates; competitive products or approaches limiting the commercial value of the Company's product candidates; the timing and results of preclinical and clinical studies; the Company's ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company's ability to protect its intellectual property; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's latest Annual Report on Form 10-K and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected] STRUCTURE THERAPEUTICS INC.Condensed Consolidated Statements of Operations(unaudited)(In thousands) THREE MONTHS ENDED MARCH 31, 2026 2025 Operating expenses: Research and development $66,507 $42,867 General and administrative 22,872 13,444 Total operating expenses 89,379 56,311 Loss from operations (89,379) (56,311)Interest and other income, net 13,601 9,576 Loss before provision for income taxes (75,778) (46,735)Provision for (benefit from) income taxes 190 98 Net loss $(75,968) $(46,833) Research and development $5,101 $2,699 General and administrative 6,538 3,219 Total share-based compensation $11,639 $5,918 STRUCTURE THERAPEUTICS INC.Condensed Consolidated Balance Sheet Data(unaudited)(In thousands) MARCH 31, DECEMBER 31, 2026 2025 Assets Current assets: Cash, cash equivalents and short-term investments $1,458,504 $1,446,197 Prepaid expenses and other current assets 32,094 124,106 Total current assets 1,490,598 1,570,303 Property and equipment, net 6,365 6,653 Operating right-of-use assets 5,606 6,245 Other non-current assets 5,555 717 Total assets $1,508,124 $1,583,918 Liabilities and shareholders’ equity Current liabilities: Accounts payable $7,822 $13,864 Accrued expenses and other current liabilities 46,553 46,543 Operating lease liabilities, current portion 2,609 2,878 Total current liabilities 56,984 63,285 Operating lease liabilities, net of current portion 3,183 3,609 Other non-current liabilities 863 647 Total liabilities 61,030 67,541 Total shareholders’ equity 1,447,094 1,516,377 Total liabilities and shareholders’ equity $1,508,124 $1,583,918 |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-11 02:35
2mo ago
|
Nxera Pharma Announces Progress of Out-Licensing of GPCR-targeted Program and Participation in Series A Financing | FMP Stock News | |
|
Original source text
May 11, 2026 02:35 ET | Source: Nxera PharmaNew company (“NewCo”) co-founded by Nxera with a syndicate of leading healthcare and life sciences-focused investment firms.In return for granting an exclusive worldwide license to the program, Nxera is eligible to receive up to US$275 million in development and commercial milestone payments as well as tiered royalties. In addition, Nxera retains rights to Japan and certain Asia-Pacific territories and now holds a significant minority equity stake in the NewCo.Builds toward the establishment of an asset spin-out model, following Orexia Therapeutics/Centessa Pharmaceuticals, which announced an agreement to be acquired by Lilly. Tokyo, Japan and Cambridge, UK, 11 May 2026 – As announced on 12 February 2026, Nxera Pharma Co., Ltd. (“Nxera” or the “Company”) entered into a license agreement with a newly established company (“NewCo”) to advance a specific GPCR-targeted program owned by Nxera. Nxera today announces that, in connection with the closing of a Series A financing undertaken by NewCo, Nxera and a syndicate of leading healthcare and life sciences-focused investors have entered into an investment agreement with NewCo. NewCo will accelerate preclinical studies of a GPCR program against a target discovered using Nxera’s NxWave™ technology platform and advance the program toward global clinical trials. By participating in the Series A financing, Nxera will continue its partnership with NewCo to maximize impact for patients and the value of the program for shareholders. Under the terms of the license agreement, Nxera has granted NewCo an exclusive worldwide license to develop, manufacture and commercialize a GPCR program currently at pre-clinical stage (target undisclosed), excluding Japan and certain Asia-Pacific territories. Nxera is eligible to receive up to US$275 million in milestone payments based on development and commercial progress, plus tiered royalties. In addition, following NewCo’s formation, the execution of the license agreement and completion of the Series A financing, Nxera holds a significant minority equity stake in NewCo on a fully diluted basis. The program is outside Nxera's core metabolic and rare endocrine focus, and the spin-out structure allows it to be advanced with dedicated external capital and leadership. Dr. Patrik Foerch, Nxera’s Chief Scientific Officer and President of Nxera Pharma UK, has joined NewCo’s Board of Directors. Through this representation, Nxera will continue the work with NewCo under appropriate governance on development execution and key strategic decisions, with the joint aim of accelerating and maximizing the value of the program. Christopher Cargill, President and CEO of Nxera Pharma, commented: “This transaction marks Nxera’s second deployment of a spin-out model already validated by Orexia Therapeutics, whose orexin 2 receptor agonist pipeline was further developed via Centessa Pharmaceuticals and is being acquired by Lilly for up to approximately US$7.8 billion. The model allows us to accelerate the development of promising and differentiated, but non-core GPCR-targeted assets from NxWave™ into global clinical trials while retaining equity, milestones and royalties. Crucially, we have kept rights in Japan and parts of Asia-Pacific in this new transaction, so that if development succeeds, we can advance and deliver this medicine directly to patients in our home markets.” –END– About Nxera Pharma Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. The Company has built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high-value, large and growing market and those in the broader APAC region. In addition, the Company is advancing an extensive pipeline internally and in partnership with leading pharma and biotech companies powered by its unique NxWave™ GPCR structure-based drug discovery platform. Nxera Pharma operates at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit www.nxera.life LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor Relations Shinya Tsuzuki, VP, Head of Investor Relations Maya Bennison, Communications Manager +81 (0)3 5210 3399 | +44 (0)1223 949390 |[email protected] MEDiSTRAVA (for International Media) Mark Swallow, Frazer Hall, Erica Hollingsworth +44 (0)203 928 6900 | [email protected] Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-13 12:52
2mo ago
|
Lilly Bets on Next-Generation Obesity Drugs to Stay Ahead | FMP Stock News | |
|
Original source text
Key Takeaways Lilly is advancing oral obesity pills and next-gen GLP-1 drugs to stay ahead in weight loss.LLY's retatrutide showed strong weight loss and osteoarthritis pain relief in phase III studies.Lilly is testing eloralintide and bimagrumab to expand beyond traditional GLP-1 therapies. Eli Lilly and Company (LLY - Free Report) is a leader in the fast-growing diabetes and obesity market, driven by its blockbuster tirzepatide-based drugs, Mounjaro and Zepbound. Tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), remains the foundation of Lilly’s obesity franchise. Beyond obesity and diabetes, Lilly is evaluating tirzepatide in several obesity-related conditions, such as obstructive sleep apnea (OSA), chronic kidney disease, fatty liver disease and cardiovascular conditions.Mounjaro and Zepbound face strong competition from Novo Nordisk’s (NVO - Free Report) semaglutide medicines, Ozempic, for diabetes and Wegovy for obesity. Though Lilly and Novo Nordisk presently dominate the market, they are making rapid progress in the development of more potent and convenient GLP-1 as well as non-GLP-1 based candidates in their clinical pipeline to beat future competition. The global obesity drug market is projected to grow dramatically, reaching nearly $95 billion by 2030 and potentially $125 billion by 2035, according to Goldman Sachs estimates, which means competition is inevitable. Oral Obesity Drugs Could Be a Commercial Game-ChangerBoth Lilly and NVO have launched oral GLP-1 pills. Lilly’s Foundayo and Novo Nordisk’s Wegovy pill can prove to be commercial game-changers for the respective companies. Oral pills will be a more convenient alternative to the currently available once-weekly injectable obesity treatments like Zepbound and Wegovy. Oral pills may significantly lower the treatment burden and potentially broaden patient adoption versus injections. Oral pills can also be manufactured at scale to meet global demand, which, in turn, can drive billions in additional sales. Both Lilly and Novo Nordisk said their oral pills witnessed strong launches. Lilly expects to launch Foundayo in most international markets during 2027. For the type II diabetes indication, Lilly has filed regulatory applications for Foundayoin several countries, while it expects to file the same in the United States in late second quarter. In addition to obesity and diabetes, Lilly is evaluating Foundayo in six phase III studies for other diabetes and obesity-related diseases. Retatrutide May Succeed Tirzepatide in Lilly’s PortfolioLilly is developing several next-generation, more powerful and more convenient GLP-1–based treatments, including oral options and multi-acting candidates. Its obesity and diabetes pipeline has therefore evolved from a traditional insulin and diabetes-drug portfolio into a comprehensive metabolic-disease platform. A key candidate in its obesity pipeline is triple-acting incretin, retatrutide, being studied in type II diabetes and obesity, along with other indications like OSA, knee osteoarthritis, and chronic low back pain, in late-stage studies. Retatrutide represents a new generation of “triple-action” therapy as it targets three biological pathways — GLP-1, GIP and glucagon — whereas existing medicines mostly act on one or two biological pathways. Data from a phase III study of retatrutide in obesity and knee osteoarthritis pain showed that the drug led to significant weight loss and substantial relief of osteoarthritis pain. Data from a phase III study in type II diabetes showed that retatrutide can achieve glycemic control comparable to tirzepatide, while providing additional weight loss. Eloralintide and Bimagrumab Expand Lilly Beyond GLP-1 TherapiesAnother key candidate in Lilly’s diabetes/obesity pipeline is eloralintide, a selective amylin receptor agonist. Lilly is exploring eloralintide both alone and in combination with incretin therapies. Phase III studies are ongoing for obesity, OA knee pain and OSA. Lilly believes that eloralintide has the potential to be a great medicine for patients seeking a non-GLP-1-based mechanism due to tolerability issues. Through its 2023 acquisition of Versanis, Lilly gained bimagrumab, an ActRII inhibitor being studied alone and in combination with tirzepatide to improve body composition by reducing fat while maintaining or increasing lean muscle mass. It is in phase II studies for obesity. Competition Heating Up in the Obesity SpaceNovo Nordisk’s other novel candidate in its obesity pipeline is CagriSema, a once-weekly injection, which is a combination of cagrilintide (amylin analogue) and semaglutide (GLP-1). NVO has already filed a new drug application with the FDA seeking approval of CagriSema for obesity. Other key candidates are cagrilintide, a long-acting amylin analog in phase III, and amycretin, a single molecule combining GLP-1 + amylin, which is expected to enter phase III in 2026. Several other companies, like Amgen, Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) are also making rapid progress in the development of more potent and convenient candidates in their clinical pipeline. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026. Structure Therapeutics’ phase II ACCESS study on its orally GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026. Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with a monthly and possibly less frequent dosing. This key feature differentiates it from Zepbound and Wegovy, which are weekly injections. Amgen has nine global phase III studies underway with MariTide in obesity, type II diabetes and other obesity-related conditions. LLY’s Stock Price, Valuation and EstimatesLilly’s stock has declined 7.9% so far this year compared with the industry’s decrease of 4%. Image Source: Zacks Investment Research From a valuation standpoint, Lilly’s stock is expensive. Going by the price/earnings ratio, LLY’s shares currently trade at 25.46 forward earnings, much higher than 16.47 for the industry. However, LLY’s stock is trading below its 5-year mean of 34.57. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2026 has risen from $34.69 to $35.43 per share over the past 30 days, while that for 2027 has risen from $42.98 to $44.26 per share over the same timeframe. Image Source: Zacks Investment Research LLY’s Zacks RankLilly has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-14 11:20
2mo ago
|
Can Novo Nordisk Sustain Its GLP-1 Edge Amid Lilly's Growing Pressure? | FMP Stock News | |
|
Original source text
Key Takeaways Novo Nordisk raised its 2026 outlook after strong Q1 GLP-1 sales beat estimates.NVO faces rising pressure from Lilly's Mounjaro, Zepbound and oral GLP-1 drug Foundayo.Novo Nordisk is expanding Wegovy, Ozempic and Rybelsus labels to defend market share. Novo Nordisk (NVO - Free Report) is a dominant player in the GLP-1 space, marketing its semaglutide drugs under brand names Ozempic (pre-filled pen) and Rybelsus (oral tablet) for type II diabetes (T2D), and Wegovy (injection and oral tablet) for chronic weight management.Novo Nordisk’s growth trajectory was notably pressured in 2025 by the widespread availability of compounded GLP-1 alternatives in the obesity market, eroding demand for its branded therapies. In 2026, the company succeeded in curbing the proliferation of these compounded products through legal measures, stricter FDA oversight and strategic partnerships with telehealth providers. Despite this progress, Novo Nordisk continues to face broader structural challenges that weigh on its sales growth and compress operating margins. Investor sentiment improved after NVO comfortably beat earnings and revenue expectations in the first quarter, driven by higher GLP-1 sales. The company also raised its 2026 outlook, signaling that management may be regaining control following months of slowing growth concerns. Novo Nordisk now expects adjusted sales and operating profit to decline 4-12% at CER in 2026 compared with its earlier forecast of a 5-13% decline, supported by rising GLP-1 demand, especially in obesity care, broader treatment adoption and continued Wegovy launches in new markets. NVO Threatened by LLY’s Expanding GLP-1 Market PresenceNovo Nordisk’s near-term visibility remains clouded primarily by intensifying competition from Eli Lilly (LLY - Free Report) , accompanied by other factors, like pricing pressure in the United States, weaker injectable GLP-1 prescription trends and reduced Medicaid obesity coverage. Additional risks include the MFN pricing agreement, gradual semaglutide exclusivity losses in certain markets and elevated spending on R&D, manufacturing and commercial expansion. Eli Lilly continues to strengthen its position in the obesity and diabetes markets, raising questions about Novo Nordisk’s ability to defend market share and maintain pricing power over time. LLY also comprehensively beat earnings and revenue estimates in the first quarter of 2026, driven by robust volume growth in its tirzepatide (GLP-1) injections, including Mounjaro for T2D and Zepbound for obesity, which compete directly with NVO’s Ozempic and Wegovy. Novo Nordisk gained a first-mover advantage in oral obesity treatments after launching an oral version of Wegovy in January 2026, ahead of Eli Lilly’s oral GLP-1 drug, Foundayo. However, Lilly could quickly narrow the gap as Foundayo offers greater convenience with no food restrictions, while oral Wegovy must be taken on an empty stomach. Wegovy, though, appears to have a more favorable safety and tolerability profile, with fewer gastrointestinal side effects. To strengthen its position, Novo Nordisk is expanding its obesity and diabetes portfolio through new approvals and label expansions. Rybelsus’ label was expanded to lower cardiovascular risk in high-risk T2D patients, while Wegovy expanded its reach with cardiovascular, HFpEF and osteoarthritis indications alongside approvals for higher-dose injections in the United States and Europe. Meanwhile, Ozempic remains the only GLP-1 approved to slow kidney disease progression and reduce cardiovascular death in diabetes patients, with additional label expansion efforts underway for peripheral artery disease. The FDA recently approved an oral version of Ozempic for adult T2D patients, which NVO is planning to launch soon. A supplemental application for a higher 25 mg tablet is also under review, with a regulatory decision expected by the end of 2026. Novo Nordisk also intends to seek regulatory approval for both Rybelsus and oral Ozempic in pediatric patients with T2D in the United States and the EU in the second half of 2026. It also continues to advance multiple next-generation obesity and diabetes candidates to reinforce the long-term growth outlook. Small Biotechs Eye Entry Into the Obesity Pill MarketThe obesity space is also attracting new contenders to challenge the incumbents. Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026. Structure Therapeutics’ phase II ACCESS study on its orally administered GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026. NVO’s Stock Price, Valuation & EstimatesYear to date, Novo Nordisk shares have lost 7.4% compared with the industry’s 2.3% decline. The company has also underperformed the sector and the S&P 500 during the same time frame, as seen in the chart below. NVO Stock Underperforms the Industry, Sector & the S&P 500Image Source: Zacks Investment Research Novo Nordisk is trading at a discount to the industry, as seen in the chart below. Going by the price/earnings ratio, the company’s shares currently trade at 13.77 forward earnings, which is lower than 16.73 for the industry. The stock is trading much below its five-year mean of 29.25. NVO Stock’s ValuationImage Source: Zacks Investment Research Earnings estimates for 2026 have improved from $3.37 to $3.47 per share over the past 30 days. During the same time frame, Novo Nordisk’s 2027 earnings estimates have increased from $3.41 to $3.44 per share. NVO’s Estimate MovementImage Source: Zacks Investment Research Novo Nordisk currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-17 14:22
2mo ago
|
This Obesity Drug Stock Has Jumped 60% as Phase 3 Plans Advance. A Fund Just Sold $4.7 Million | FMP Stock News | |
|
Original source text
HighVista Strategies sold 69,092 shares of Structure Therapeutics (GPCR +4.26%) in the first quarter, an estimated $4.73 million trade based on quarterly average pricing, per the May 15, 2026 SEC filing.What happenedAccording to an SEC filing dated May 15, 2026, HighVista Strategies reduced its holding in Structure Therapeutics by 69,092 shares during the first quarter. The estimated transaction value was $4.73 million, calculated using the average closing price for the quarter. The position’s quarter-end value decreased by $7.45 million, a figure that incorporates both the share sale and market price fluctuations. What else to knowThis was a sell; post-trade, the Structure Therapeutics stake represents 1.6491% of HighVista’s reportable U.S. equity AUMTop holdings after the filing:NYSEMKT:DBC: $30.61 million (8.5% of AUM)NASDAQ:ABVX: $12.61 million (3.5% of AUM)NASDAQ:PRAX: $8.48 million (2.3% of AUM)NASDAQ:COGT: $7.58 million (2.1% of AUM)NASDAQ:SYRE: $7.38 million (2.0% of AUM)As of May 14, 2026, shares of Structure Therapeutics were priced at $39.84, up about 60% over the past year and well outperforming the S&P 500’s roughly 25% gain in the same period.Company OverviewMetricValuePrice (as of market close 2026-05-14)$39.84Market Capitalization$2.8 billionNet Income (TTM)($141.2 million)One-Year Price Change60%Company SnapshotStructure Therapeutics develops oral therapeutics targeting chronic diseases, with lead candidate GSBR-1290 for type-2 diabetes and obesity, and additional pipeline assets for pulmonary and cardiovascular indications.The company operates a clinical-stage biopharmaceutical business model focused on proprietary research, development, and out-licensing or commercialization of novel small molecule drugs targeting G-protein-coupled receptors (GPCRs).It targets healthcare providers, biopharma partners, and patients with unmet medical needs in metabolic, pulmonary, and cardiovascular disease segments.Structure Therapeutics Inc. is a clinical-stage biotechnology company specializing in the development of innovative oral small molecule therapeutics for chronic diseases with significant unmet need. The company's strategy leverages expertise in GPCR biology to advance a pipeline of differentiated oral therapeutics for chronic diseases. With a focus on metabolic and pulmonary indications, Structure Therapeutics seeks to establish a competitive edge through proprietary drug design and a robust clinical development program. What this transaction means for investorsStructure Therapeutics shares have climbed about 60% over the past year as investors piled into companies developing next-generation GLP-1 therapies, especially oral alternatives to injectable weight-loss drugs. With that kind of run, it doesn’t seem surprising for a fund to consider rebalancing. For its part, the company has continued delivering strong clinical updates. Earlier this month, Structure reported Phase 2 data showing up to 16.3% placebo-adjusted weight loss at 44 weeks for oral obesity candidate aleniglipron, which management said compares favorably with injectable GLP-1 therapies. The company also said it received positive end-of-Phase 2 FDA feedback and remains on track to launch Phase 3 trials in the third quarter. Separately, Structure ended March with roughly $1.5 billion in cash, cash equivalents, and short-term investments, which management says should fund operations through the end of 2028. Ultimately, the key question is whether oral GLP-1 drugs can carve out a meaningful slice of a market currently dominated by injectable therapies. High expectations are already baked into many obesity stocks, but Structure’s growing clinical data package suggests the company remains one of the more serious contenders in the space. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-20 15:27
2mo ago
|
Monashee Scales Back Its Bet on Structure Therapeutics | FMP Stock News | |
|
Original source text
What happenedAccording to a recent SEC filing dated May 13, 2026, Monashee Investment Management reduced its holding in Structure Therapeutics (GPCR +4.26%) by 175,000 shares during the first quarter. The estimated transaction value was $11.98 million, based on the quarter’s average closing price. The value of Monashee’s GPCR position decreased by $13.24 million over the quarter, a figure that includes both trading and stock price effects.What else to knowThis was a reduction; the remaining stake accounts for 1.8% of Monashee’s 13F reportable assets.Top five holdings post-filing:LSE: TERN: $15.82 million (8.6% of AUM)NYSE: NEE $15.22 million (8.3% of AUM)NASDAQ: MDLN: $13.35 million (7.3% of AUM)NYSE: NRG: $12.42 million (6.8% of AUM)NYSE: FPS: $10.24 million (5.6% of AUM)As of May 19, 2026, Structure Therapeutics shares were priced at $35.88, up 42.55% from a year earlier, outperforming the S&P 500 by 10.24 percentage points.Company overviewMetricValueMarket Capitalization$2.57 billionEmployees220Net Income (TTM)($170.37 million)Price (as of market close May 19, 2026)$35.88Company snapshotDevelops oral therapeutics for chronic diseases, including type 2 diabetes, obesity, and pulmonary and cardiovascular conditions, with a lead candidate, GSBR-1290, targeting GLP-1 receptor agonism.Operates a clinical-stage biopharmaceutical business model, investing in R&D to advance proprietary small-molecule drugs through clinical trials for future commercialization.Targets healthcare providers and patients with unmet medical needs in metabolic, pulmonary, and cardiovascular disease markets.Structure Therapeutics is a clinical-stage biotechnology company specializing in the development of novel oral therapies for chronic and serious diseases. With a focused pipeline led by GSBR-1290 for type-2 diabetes and obesity, the company leverages expertise in G-protein-coupled receptor (GPCR) drug targets to address significant market opportunities. Its strategy emphasizes innovation in small-molecule drug design, aiming to deliver differentiated treatments to large, underserved patient populations. What this transaction means for investorsMonashee sharply reduced its position in Structure Therapeutics, cutting its holdings from roughly 225,000 shares to about 50,000 shares -- even as the company itself seems to be doing well. So, what does this indicate about Structure's future potential? The weight loss drug market, especially GLP-1, has become extremely competitive. While it’s still dominated by injectable medications such as Ozempic and Wegovy, oral therapies are gaining ground fast. That’s the market Structure Therapeutics hopes to reach. Structure continues to post encouraging results in clinical testing. Its lead candidate, aleniglipron, has shown strong results in phase 2 trials. Pill-based treatments could be easier and less costly to manufacture and distribute, and may also be more attractive to patients than injectables. The question is, who will win the race? Structure is far from the only pharmaceutical company developing oral GLP-1 weight loss medications. Monashee’s decision to significantly reduce its position, rather than fully exit, may signal caution as the race intensifies. Rather than trying to analyze individual pharma stocks, individual investors may prefer an ETF with a broader focus in the GLP-1 industry, such as Roundhill GLP-1 & Weight Loss ETF (NASDAQ: OZEM), which holds several different companies in the space. Pamela Kock has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Medline. The Motley Fool recommends Forgent Power Solutions. The Motley Fool has a disclosure policy. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-21 12:36
2mo ago
|
Can Mounjaro, Zepbound & Foundayo Keep Fueling LLY's Growth Story? | FMP Stock News | |
|
Original source text
Key Takeaways Mounjaro and Zepbound saw strong Q1 sales growth, fueled by robust demand despite lower pricing.New label expansions and indication approvals could further boost Mounjaro and Zepbound sales.Foundayo has reached over 20,000 U.S. patients and a launch is planned for most international markets in 2027. Eli Lilly (LLY - Free Report) has emerged as a dominant force in the cardiometabolic market, driven by strong demand for its blockbuster GLP-1 therapies, Mounjaro for type II diabetes (T2D) and Zepbound for obesity. Both drugs include the same compound, tirzepatide, a dual GIP/GLP-1 RA. The GLP-1 segment is a very important class of drugs for multiple cardiometabolic diseases and is gaining significant popularity.Despite a short time on the market, Mounjaro and Zepbound have become LLY’s key top-line drivers. Mounjaro is the market leader in new prescriptions among incretin analogs for T2D in both the United States and ex-U.S. markets. At the same time, Zepbound holds a leading market share in the branded obesity market, with nearly 70% of new prescriptions. In the first quarter of 2026, Mounjaro recorded sales of $8.66 billion, up 125% year over year, while Zepbound’s sales were $4.16 billion, up 80% year over year, driven by increased demand, which offset the impact of lower pricing. The positive trend is expected to continue in 2026. New indication approvals and ongoing label expansions could further boost sales of Eli Lilly’s Mounjaro and Zepbound. Last year, Zepbound gained FDA approval for obstructive sleep apnea in adults with obesity, while LLY has also filed for a cardiovascular indication based on positive late-stage data. Tirzepatide has also been approved for pediatric and adolescent T2D in the United States and the EU, with additional studies underway in type I diabetes and metabolic dysfunction-associated steatotic liver disease. Lilly is also supporting growth through lower-priced Zepbound vial doses, self-pay savings programs and expanded incretin manufacturing capacity. Eli Lilly’s newly approved once-daily oral GLP-1 pill, Foundayo, has shown encouraging early launch momentum in obesity, with broad pharmacy availability, access through major telehealth platforms and commercial coverage from two of the three largest U.S. pharmacy benefit managers. More than 8,000 healthcare providers have prescribed the drug, while over 20,000 patients have received it so far, with most prescriptions coming from people new to GLP-1 therapy. Lilly plans to launch Foundayo in most international markets in 2027 and is pursuing approvals for T2D in several countries, with a U.S. filing expected in late second-quarter 2026. Backed by consistent safety and efficacy data across seven phase III studies, Foundayo is being positioned as a key growth driver for Lilly in obesity, diabetes and related metabolic diseases. LLY’s Peers in the Obesity SpaceEli Lilly and Novo Nordisk (NVO - Free Report) presently dominate the obesity market. Mounjaro and Zepbound directly compete with NVO’s semaglutide medicines, Ozempic for T2D and Wegovy for obesity. Like Eli Lilly, Novo Nordisk also generates a substantial portion of revenues from both drugs. Novo Nordisk gained approval for an oral version of its obesity drug, Wegovy, in December 2025 and launched the pill in January 2026, giving it a first-mover advantage over Foundayo. However, Lilly may be able to close the gap quickly now that it has launched Foundayo. Also, Foundayo offers better patient convenience, as it can be taken at any time of day, with or without food. In contrast, NVO’s Wegovy pill must be taken on an empty stomach, followed by a 30-minute wait before eating. However, in terms of side effects, Wegovy has a slight edge, as it appears to have a more stable safety and tolerability profile than Foundayo, whose use is associated with some gastrointestinal side effects. Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking Therapeutics plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026. Structure Therapeutics’ phase II ACCESS study on its orally administered GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026. LLY’s Stock Price, Valuation and EstimatesShares of Eli Lilly have lost 5.2% year to date compared with the industry’s 0.7% decline. During the same time frame, the company has also underperformed the S&P 500 but outperformed the sector, as seen in the chart below. LLY Stock Price MovementImage Source: Zacks Investment Research From a valuation standpoint, LLY stock is expensive. Going by the price/earnings ratio, the company’s shares currently trade at 26.23 forward earnings, higher than 16.98 for the industry. However, the stock is trading below its five-year mean of 34.56. LLY Stock ValuationImage Source: Zacks Investment Research Estimates for Eli Lilly’s 2026 earnings have improved from $34.70 to $35.45 per share in the past 30 days, and estimates for 2027 earnings have improved from $42.67 to $44.23 per share over the same time frame. LLY Estimate MovementImage Source: Zacks Investment Research Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-24 10:19
2mo ago
|
This Biotech Is Up 60%. A Top Healthcare Fund Just Bought Another $11 Million | FMP Stock News | |
|
Original source text
Deep Track Capital disclosed a buy of 168,066 additional Structure Therapeutics (GPCR +4.26%) shares in its May 15, 2026, SEC filing, with an estimated transaction value of $11.50 million based on quarterly average pricing.What happenedAccording to its SEC filing dated May 15, 2026, Deep Track Capital increased its position in Structure Therapeutics by 168,066 shares during the first quarter. The estimated transaction value was $11.50 million, calculated using the average closing price for the quarter. The quarter-end value of the stake decreased by $79.69 million, a change that includes both share purchases and stock price movement. What else to knowThis buy brought the GPCR stake to 3.37% of the fund's $6.12 billion in reportable U.S. equity holdings as of March 31, 2026.Top holdings post-filing:NASDAQ:GH: $308.35 million (6.36% of AUM)NASDAQ:IMVT: $286.33 million (5.91% of AUM)NASDAQ:TARS: $252.54 million (5.21% of AUM)NASDAQ:PCVX: $249.87 million (5.16% of AUM)NASDAQ:AXSM: $185.92 million (3.84% of AUM)As of Friday, shares were priced at $39.19, up 60% over the past year and well outperforming the S&P 500, which is up about 28% in the same period.Company OverviewMetricValuePrice (as of Friday)$39.19Market Capitalization$2.8 billionNet Income (TTM)($170.3 million)Company SnapshotStructure Therapeutics develops oral small-molecule therapeutics targeting G-protein-coupled receptors (GPCRs) for chronic diseases, with a lead candidate (GSBR-1290) focused on type-2 diabetes and obesity, and additional programs in pulmonary and cardiovascular conditions.The firm operates a clinical-stage biopharmaceutical business model, investing in research and development to advance proprietary drug candidates through clinical trials with the aim of future commercialization and licensing.It targets patients with chronic metabolic, pulmonary, and cardiovascular diseases, addressing unmet medical needs in global healthcare markets.Structure Therapeutics is a clinical-stage biotechnology company headquartered in South San Francisco, California, with a focus on advancing novel oral therapeutics for chronic diseases. The company leverages expertise in GPCR-targeted drug discovery to address significant unmet needs in metabolic and pulmonary indications. Its pipeline and differentiated approach position it to compete in the evolving landscape of oral therapeutics for complex diseases. What this transaction means for investorsBy adding to a position after a strong run, Deep Track is suggesting it believes important value-creating milestones are still ahead for Structure, even after a nearly 60% run this past year. The company has been building a compelling case for aleniglipron, its oral GLP-1 candidate. In March, it reported Phase 2 data showing up to 16.3% weight loss at 44 weeks, which management described as the highest efficacy reported among oral GLP-1 drugs and potentially comparable to injectable therapies. The company also received positive end-of-Phase 2 feedback from the FDA and remains on track to begin Phase 3 studies in the third quarter of 2026. CEO Raymond Stevens said the company is "well positioned" to launch its registrational program and highlighted additional amylin and combination therapy opportunities that could broaden the pipeline. Structure also remains well-funded, ending the quarter with roughly $1.5 billion in cash, cash equivalents, and short-term investments, enough to support operations through the end of 2028. Ultimately, the key question going forward is whether aleniglipron can continue producing competitive efficacy as it moves into larger studies. If it can, Structure could emerge as a meaningful player in the rapidly expanding obesity market. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Axsome Therapeutics and Guardant Health. The Motley Fool has a disclosure policy. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-26 08:50
2mo ago
|
If Viking Therapeutics Is Acquired, Here’s Who Wins | FMP Stock News | |
|
Original source text
© Pattanaphong Khuankaew / Getty ImagesPolymarket traders are watching one biotech more closely than any other for an acquisition. Viking Therapeutics (NASDAQ: VKTX | VKTX Price Prediction) carries a 38.5% implied probability of being acquired before 2027, with all-time volume above $1.68 million on that single contract. The hook is obesity. Viking’s VK2735 dual GLP-1/GIP agonist is arguably the most advanced obesity asset not yet owned by Big Pharma. This scenario analysis examines who would actually benefit if a deal happens. Why Viking Is the Most-Watched M&A Target Viking is a clinical-stage biotech with no revenue and a market cap near $3.59 billion. Shares closed at $30.89 on May 22, 2026, down 12.2% year to date. Analyst sentiment, however, is striking, with almost all analysts rating it Buy or Strong Buy, and a mean target price all the way up at $92.33. The lead asset is doing the talking. Oral VK2735 delivered up to 12.2% weight loss at 13 weeks, with 80% of participants achieving at least 10% weight loss. Phase 3 VANQUISH-1 is fully enrolled with 4,500+ patients. Cash burn is accelerating: Q4 2025 net loss hit $157.66 million against roughly $706 million in cash, sharpening the strategic clock. Existing Shareholders Benefit For current holders, the standalone case is the $92.33 analyst target, which assumes successful Phase 3 readouts. A deal would compress that timeline. Biotech buyouts of clinical-stage assets have historically closed well above prevailing prices, and recent obesity deals (notably Pfizer’s roughly $9.8 billion Metsera acquisition) set a reference point. Speculative buyout investing remains one of the highest-risk strategies in biotech: trial setbacks, regulatory delays, and deal breaks can all hit hard. The Potential Buyer Benefits Eli Lilly (NYSE: LLY) already dominates the category. Q1 2026 revenue of roughly $19.8 billion grew 55.5%, with Mounjaro and Zepbound leading. A second platform still adds optionality, though antitrust optics complicate the fit at its $949.7 billion market cap. Pfizer (NYSE: PFE) has been the most active acquirer in obesity. CEO Albert Bourla said, “2026 will be an important year rich in key catalysts, including our expectation for approximately 20 key pivotal study starts.” A Phase 3-ready dual agonist would integrate directly into the Metsera pipeline buildout. Novo Nordisk (NYSE: NVO) is defending share. Shares are down 33.2% over the past year, and 2026 guidance calls for adjusted sales growth of −4% to −12%. A defensive bid is plausible. Merck and Amgen round out the longer-shot list. Merck is underweight obesity and already acquiring Terns Pharmaceuticals, while Amgen has MariTide advancing internally, which may reduce urgency rather than create it. Competitors and the Industry Benefit The clearest secondary winner is Structure Therapeutics (NASDAQ: GPCR), whose oral aleniglipron delivered 16.3% placebo-adjusted weight loss at 44 weeks. With a $2.8 billion market cap and a $106.47 average analyst target, Structure would inherit the scarcity premium if Viking is removed from the board. The Terns deal already shows Big Pharma’s willingness to consolidate metabolic assets. For the broader industry, a Viking transaction would validate the tuck-in playbook, likely re-rate the obesity small-cap basket, and serve as an FTC test case for GLP-1 consolidation. It would also mark Polymarket as a usable M&A signal in biotech research. The Bottom Line Even with 61.5% odds priced against a deal, Viking remains at the center of the obesity M&A conversation. If a transaction occurs, shareholders, the acquirer, and the broader obesity basket all stand to gain. Worth watching: Phase 3 enrollment updates, oral VK2735 progress, and any Big Pharma business development signaling through the rest of 2026. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-05-26 16:05
2mo ago
|
Structure Therapeutics Announces Participation in Upcoming Investor Conferences | FMP Stock News | |
|
Original source text
SAN FRANCISCO, May 26, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced that management will participate in two upcoming healthcare conferences in June:2026 Jefferies Global Healthcare Conference Format:Fireside chat and 1x1 meetings Date/time:Wednesday, June 3 at 12:15 p.m. ET Location:New York, NY Goldman Sachs 47th Annual Global Healthcare Conference Format:Fireside chat and 1x1 meetings Date/time:Tuesday, June 9 at 10:00 a.m. ET Location:Miami, FL The live and archived webcasts will be accessible from the company’s website at https://ir.structuretx.com/events-presentations/events and replays will be available for 90 days. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-05 16:05
1mo ago
|
Structure Therapeutics Announces Publication in Nature Medicine Highlighting Phase 2b ACCESS Program of Aleniglipron for Obesity | FMP Stock News | |
|
Original source text
Publication presented concurrently with oral presentation atAmerican Diabetes Association’s 86th Scientific Sessions from ACCESS development program with aleniglipron, a once-daily oral small molecule GLP-1 receptor agonist Publication and presentation detail dose-dependent, clinically meaningful and statistically significant reductions in body weight with continued weight loss beyond 36 weeks, up to 16.2% during the open-label extension Aleniglipron safety profile reflects well-known GI-related GLP-1 class adverse events, with favorable tolerability profile demonstrated by an overall low (10.4%) discontinuation rate Phase 3 program remains on track to initiate in Q3 2026 Additional presentations related to Structure’s obesity pipeline, including amylin and combination data, expected at the American Diabetes Association’s 86th Scientific Sessions SAN FRANCISCO, June 05, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced a publication in Nature Medicine detailing results from the Phase 2b ACCESS clinical trial of aleniglipron for the treatment of people living with obesity and/or overweight with at least one weight related co-morbidity. The Nature Medicine publication, titled, "Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial," can be accessed online at: https://www.nature.com/articles/s41591-026-04476-6. The publication was released concurrent with an oral presentation during the American Diabetes Association’s 86th Scientific Sessions by lead author, Julio Rosenstock, MD, Chair of the aleniglipron program Steering Committee and Clinical Professor of Medicine, University of Texas, Southwestern Medical Center. The data highlights the efficacy from three maintenance dose levels in the core Phase 2b ACCESS study, as well as a predefined interim analysis of the open-label extension (OLE) safety study that demonstrated the durability of weight loss beyond 36 weeks, and improved tolerability from a lower 2.5 mg starting dose. The data from these studies provide support for the study design of the upcoming Phase 3 program which is expected to initiate in the third quarter of 2026. “The data published today provide important new details around the previously reported reductions in body weight in patients dosed with aleniglipron. Interestingly, participants continued to lose weight after a median follow up of 20 weeks in the open label extension phase of the study after finalizing the 36 weeks in the double-blind treatment period, with no apparent weight loss plateau. This is an important distinction for a once-daily oral, non-peptide GLP-1 receptor agonist to potentially become an additional treatment option for patients,” stated Dr. Rosenstock, MD, Chair of the Steering Committee. “The study closely monitored the participant experience and additional impacts across key measures of tolerability, including the ability to restart or increase dosing titration after interruption without substantial increase in emesis events, which may be helpful for clinicians to gain a clinical perspective of treatment tolerance.” Aleniglipron is an oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) in development for the treatment of obesity. As previously reported, at Week 36, each of the three doses in the ACCESS study achieved statistical significance on the primary endpoint and all key secondary endpoints. Other cardiovascular risk factors showed improvement with aleniglipron, such as systolic and diastolic blood pressure, hsCRP, waist circumference and HbA1c, which could positively contribute to the known cardiovascular benefits of approved GLP-1s. The interim analysis from the OLE study showed that patients continued to lose weight after a median follow up of 20 weeks, with weight loss of 13.3%, 16.2%, and 15.3% in the participants coming from 45 mg, 90 mg, and 120 mg aleniglipron arms from the double-blind treatment period, respectively. As seen in prior studies, adverse events (AEs) in the patients treated with aleniglipron are similar to those seen in the GLP-1 class of medicines. Gastrointestinal (GI) events were generally mild to moderate and decreased in frequency over time and most patient discontinuations occurred during the initial titrations in dose. There was no apparent dose-response relationship for the most common GI AEs across all aleniglipron treatment arms, and treatment discontinuations due to any treatment related adverse event (TEAE) were limited. The heat maps of dose levels overlaid with vomiting events add clarity to interpretation of the AE profile and add valuable insights into the participant experience on aleniglipron. Upon examination of each participant’s dosing across the study, it becomes clear that although some participants required dose interruptions or reductions, when the dose was re-initiated or up-titrated again, vomiting rarely recurred. This suggests that participants on aleniglipron may successfully restart treatment or continue to increase dosing after an interruption. This could potentially increase the likelihood to remain on treatment for extended periods of time, which is essential for a clinically meaningful treatment of obesity. “We are pleased to have the ACCESS study data published in Nature Medicine to provide additional details about the important outcomes from this trial. We are on track to initiate our Phase 3 program of aleniglipron in the third quarter of 2026 with a starting dose of 2.5 mg and the intent to evaluate multiple doses based on this data and our End of Phase 2 meeting with the FDA,” said Blai Coll, M.D., Ph.D., Chief Medical Officer of Structure Therapeutics. “We are confident in the potential for once-daily oral aleniglipron to transform the treatment of obesity for patients around the world.” In addition, Structure Therapeutics will have multiple other presentations related to its obesity pipeline, including amylin and combination data, at the ADA 86th Scientific Sessions. Details of the additional presentations are as follows: Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials Session: Late Breaking Poster Session (3101-LB) Date: Sunday, June 7 Time: 12:30 p.m. – 1:30 p.m. CT Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs Session: Late Breaking Poster Session (3061-LB) Date: Sunday, June 7 Time: 12:30 p.m. – 1:30 p.m. CT Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists Session: Late Breaking Poster Session (3062-LB) Date: Sunday, June 7 Time: 12:30 p.m. – 1:30 p.m. CT Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial Session: General Poster Session (2637-P) Date: Monday, June 8 Time: 12:30 p.m. – 1:30 p.m. CT Copies of these presentations will be made available on the Structure Therapeutics website at https://structuretx.com/publications/. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron and any other of the Company’s investigational compounds; and any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company’s planned Phase 3 clinical program and other clinical studies; the Company’s ability to advance aleniglipron, ACCG-2671, LTSE-2578, ACCG-3535, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company’s therapeutic candidates; competitive products or approaches limiting the commercial value of the Company’s product candidates; the Company’s ability to fund development activities and achieve development goals; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Annual Report on Form 10-K and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC 212-915-2577 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected] |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-05 17:16
1mo ago
|
Structure's experimental obesity pill shows no signs of liver injury | FMP Stock News | |
|
Original source text
CompaniesJune 5 (Reuters) - Structure Therapeutics (GPCR.O), opens new tab said on Friday its experimental GLP-1 obesity pill did not show any signs of drug-induced liver injury, and patients continued to lose weight even on the lower doses of the drug.The company said only 10.4% of patients taking the experimental small molecule drug, aleniglipron, discontinued treatment. Jumpstart your morning with the latest legal news delivered straight to your inbox from The Daily Docket newsletter. Sign up here. The results were presented at the American Diabetes Association meeting in New Orleans and published in a medical journal. The oral drug has been touted as a potential competitor to Eli Lilly's (LLY.N), opens new tab Foundayo and Novo Nordisk's (NOVOb.CO), opens new tab Wegovy pill. Patients on Structure's once-daily pill lost up to 39 lbs on the 180 mg dose after 44 weeks, compared with a placebo, in a mid-stage trial, the company had reported in March. Patients on the higher 240 mg dose lost 37 lbs or 16% of their weight. In December, the drug had shown weight loss of up to 15.3% with 240 mg dose at 36 weeks. Patients taking the 120 mg dose showed a placebo-adjusted mean weight loss of 11.3%. On Friday, the company said participants who remained on drug in the open-label extension continued to lose weight after a median follow up of 20 weeks, with weight loss of 13.3%, 16.2%, and 15.3% in participants who took 45 mg, 90 mg, and 120 mg doses of aleniglipron, respectively. There was also no weight-loss plateau, which Julio Rosenstock, chair of the aleniglipron program steering committee, said was an important distinction for a once-daily oral, non-peptide GLP-1 receptor agonist to potentially become an additional treatment option for patients. The company said it saw improved tolerability at a lower 2.5 mg starting dose, adding the data supports the design of its late stage program set to begin in the third quarter of 2026. Wall Street has been focused on better tolerability as a point of differentiation between obesity drugs. Aleniglipron is a oral pill and could appeal more to patients than injectable therapies. Aleniglipron continues to look competitive on efficacy and there is potential for improved tolerability in the late-stage trial, said J.P. Morgan analyst Hardik Parikh. The most commonly occurring side effects with aleniglipron were gastrointestinal, including nausea, diarrhea, vomiting and constipation. Structure said a review of each patient's dosing over the course of the study shows that while some required dose interruptions or reductions, vomiting rarely recurred once treatment was resumed or the dose was increased again. Serious adverse effects occurred in one participant who received the 45 mg doses, none who took 90 mg and four participants receiving 120 mg. Reporting by Sriparna Roy and Siddhi Mahatole in Bengaluru; Editing by Arun Koyyur Our Standards: The Thomson Reuters Trust Principles., opens new tab Sriparna reports on pharmaceutical companies and healthcare in the United States. She has a master's degree in English literature and post graduate diploma in broadcast journalism. |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-09 12:52
1mo ago
|
Structure Therapeutics Inc. (GPCR) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript | FMP Stock News | |
|
Original source text
Structure Therapeutics Inc. (GPCR) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript |
|||
|
Saved
2026-06-12 11:52
1mo ago
Published
2026-06-11 13:03
1mo ago
|
Structure Therapeutics: My Top Small-Cap Pick For The Obesity Market (Upgrade) | FMP Stock News | |
|
Original source text
Structure Therapeutics advances aleniglipron, a potential best-in-class oral GLP-1, into Phase 3 for obesity, supported by strong Phase 2b data. GPCR's $1.5B cash position and a projected cash runway through 2028 underpin its ability to execute pivotal trials and commercial plans. My SOTP analysis yields a fair value of $42.49/share, with aleniglipron's risk-adjusted NPV at $1.34B and pipeline assets included at no additional cost. |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-03-31 02:12
3mo ago
|
Evolv Technologies Holdings, Inc. (NASDAQ:EVLVW) Short Interest Down 27.1% in March | FMP Stock News | |
|
Original source text
Evolv Technologies Holdings, Inc. (NASDAQ:EVLVW – Get Free Report) was the recipient of a large drop in short interest in the month of March. As of March 13th, there was short interest totaling 19,363 shares, a drop of 27.1% from the February 26th total of 26,556 shares. Based on an average daily volume of 69,682 shares, the days-to-cover ratio is currently 0.3 days.Evolv Technologies Stock Up 1.3% EVLVW stock opened at $0.12 on Tuesday. The business has a 50-day moving average of $0.12 and a 200-day moving average of $0.35. Evolv Technologies has a fifty-two week low of $0.05 and a fifty-two week high of $1.08. Evolv Technologies Company Profile (Get Free Report) Evolv Technologies Holdings, Inc (NASDAQ: EVLVW) is a security technology company specializing in contactless weapons detection systems designed to enhance safety and streamline entry processes at high-traffic venues. The company’s solutions combine advanced sensor fusion with artificial intelligence to accurately detect concealed threats such as firearms and knives without requiring physical pat-downs or the removal of personal belongings. By delivering a low-friction screening experience, Evolv aims to balance robust security protocols with a positive visitor experience. The company’s flagship product, Evolv Edge, utilizes millimeter-wave radar and computer vision to identify potential threats within milliseconds as individuals walk through screening portals. Read More Five stocks we like better than Evolv Technologies Receive News & Ratings for Evolv Technologies Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Evolv Technologies and related companies with MarketBeat.com's FREE daily email newsletter. |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-18 14:10
2mo ago
|
Evolv Technologies Holdings, Inc. (EVLV) Q1 2026 Earnings Call Prepared Remarks Transcript | FMP Stock News | |
|
Original source text
Evolv Technologies Holdings, Inc. (EVLV) Q1 2026 Earnings Call Prepared Remarks Transcript |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-04-01 05:17
3mo ago
|
Allspring Global Investments Holdings LLC Cuts Position in Hilton Worldwide Holdings Inc. $HLT | FMP Stock News | |
|
Original source text
Posted by Defense World Staff on Apr 1st, 2026Allspring Global Investments Holdings LLC lowered its stake in shares of Hilton Worldwide Holdings Inc. (NYSE:HLT – Free Report) by 8.8% during the fourth quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The institutional investor owned 282,813 shares of the company’s stock after selling 27,264 shares during the period. Allspring Global Investments Holdings LLC owned about 0.12% of Hilton Worldwide worth $82,859,000 as of its most recent filing with the Securities and Exchange Commission. Other hedge funds have also made changes to their positions in the company. Vanguard Group Inc. raised its position in Hilton Worldwide by 0.6% during the third quarter. Vanguard Group Inc. now owns 25,463,196 shares of the company’s stock worth $6,606,172,000 after acquiring an additional 151,984 shares during the last quarter. JPMorgan Chase & Co. increased its position in Hilton Worldwide by 12.6% during the 3rd quarter. JPMorgan Chase & Co. now owns 10,100,718 shares of the company’s stock worth $2,620,531,000 after purchasing an additional 1,132,880 shares in the last quarter. State Street Corp increased its position in Hilton Worldwide by 0.9% during the 2nd quarter. State Street Corp now owns 9,595,709 shares of the company’s stock worth $2,555,721,000 after purchasing an additional 86,689 shares in the last quarter. Franklin Resources Inc. raised its stake in Hilton Worldwide by 10.4% in the 3rd quarter. Franklin Resources Inc. now owns 6,010,313 shares of the company’s stock valued at $1,559,316,000 after purchasing an additional 567,651 shares during the last quarter. Finally, Jennison Associates LLC lifted its stake in shares of Hilton Worldwide by 2.6% during the 3rd quarter. Jennison Associates LLC now owns 4,750,891 shares of the company’s stock worth $1,232,571,000 after purchasing an additional 119,172 shares during the period. Hedge funds and other institutional investors own 95.90% of the company’s stock. Insider Activity at Hilton Worldwide In other Hilton Worldwide news, insider Christopher J. Nassetta sold 114,289 shares of the firm’s stock in a transaction that occurred on Tuesday, February 17th. The shares were sold at an average price of $317.47, for a total value of $36,283,328.83. Following the sale, the insider owned 36,445 shares in the company, valued at approximately $11,570,194.15. This trade represents a 75.82% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this link. Insiders own 2.60% of the company’s stock. Analyst Upgrades and Downgrades Several research analysts have recently weighed in on the stock. Sanford C. Bernstein increased their price objective on shares of Hilton Worldwide from $304.00 to $322.00 in a report on Wednesday, February 25th. Macquarie Infrastructure increased their target price on Hilton Worldwide from $267.00 to $280.00 and gave the stock a “neutral” rating in a research report on Tuesday, January 13th. Jefferies Financial Group reissued a “buy” rating and set a $339.00 price target on shares of Hilton Worldwide in a research report on Wednesday, February 11th. Wells Fargo & Company boosted their target price on Hilton Worldwide from $338.00 to $373.00 and gave the stock an “overweight” rating in a report on Thursday, February 12th. Finally, Truist Financial raised their target price on shares of Hilton Worldwide from $253.00 to $307.00 and gave the company a “hold” rating in a research note on Thursday, February 12th. One equities research analyst has rated the stock with a Strong Buy rating, fourteen have assigned a Buy rating and nine have assigned a Hold rating to the stock. Based on data from MarketBeat.com, Hilton Worldwide presently has an average rating of “Moderate Buy” and an average price target of $326.18. Read Our Latest Report on HLT Key Stories Impacting Hilton Worldwide Here are the key news stories impacting Hilton Worldwide this week: Positive Sentiment: Brokerage sentiment is constructive: HLT received an average recommendation of “Moderate Buy,” signaling analyst support for the shares and potential upside if earnings meet expectations. Hilton Worldwide Holdings Inc. (NYSE:HLT) Receives Average Recommendation of “Moderate Buy” from Brokerages Positive Sentiment: Short-term buying activity lifted the stock intraday, showing continued investor appetite even as HLT has lagged broader market gains — a sign traders are positioning ahead of catalysts. Hilton Worldwide Holdings Inc. stock rises Tuesday, still underperforms market Neutral Sentiment: Upcoming catalyst: Hilton will report Q1 2026 results before the open on April 28, with management hosting a conference call — this event is likely to drive short-term volatility and could reset expectations for FY26 guidance. Hilton Announces First Quarter 2026 Earnings Release Date Neutral Sentiment: Macro/market framing is mixed: coverage notes a shifting narrative for Hilton where growth optimism competes with geopolitical and macro caution — this can keep the stock sensitive to macro headlines and guidance details. How The Hilton (HLT) Narrative Is Shifting As Growth Optimism Meets Geopolitical Caution Neutral Sentiment: Relative/peer coverage: several head‑to‑head and peer comparison pieces have been published, which may influence investor views on HLT’s competitive positioning but contain no new company‑specific catalysts. Hilton Worldwide (HLT) and Its Competitors Head-To-Head Review Neutral Sentiment: Note: an item about Hilton Food Group PLC (LSE:HFG) appeared in feeds but is a different company (food packer) and is unlikely to affect HLT’s fundamentals. Hilton Foods rises on resilient numbers and completion of strategic review Hilton Worldwide Stock Performance Shares of NYSE:HLT opened at $303.68 on Wednesday. Hilton Worldwide Holdings Inc. has a 1-year low of $196.04 and a 1-year high of $333.86. The company’s fifty day moving average is $304.89 and its two-hundred day moving average is $285.75. The stock has a market capitalization of $69.63 billion, a price-to-earnings ratio of 49.62, a price-to-earnings-growth ratio of 2.57 and a beta of 1.10. Hilton Worldwide (NYSE:HLT – Get Free Report) last released its quarterly earnings data on Wednesday, February 11th. The company reported $2.08 earnings per share for the quarter, topping the consensus estimate of $2.02 by $0.06. Hilton Worldwide had a net margin of 12.10% and a negative return on equity of 40.24%. The firm had revenue of $1.30 billion for the quarter, compared to analyst estimates of $2.99 billion. During the same quarter in the prior year, the business earned $1.76 earnings per share. Hilton Worldwide’s quarterly revenue was up 10.9% on a year-over-year basis. Hilton Worldwide has set its FY 2026 guidance at 8.490-8.610 EPS and its Q1 2026 guidance at 1.910-1.970 EPS. Sell-side analysts expect that Hilton Worldwide Holdings Inc. will post 7.89 EPS for the current fiscal year. Hilton Worldwide Dividend Announcement The company also recently announced a quarterly dividend, which was paid on Tuesday, March 31st. Shareholders of record on Friday, February 27th were given a $0.15 dividend. The ex-dividend date was Friday, February 27th. This represents a $0.60 annualized dividend and a yield of 0.2%. Hilton Worldwide’s dividend payout ratio is 9.80%. Hilton Worldwide Company Profile (Free Report) Hilton Worldwide Holdings Inc is a global hospitality company that develops, owns, manages and franchises a broad portfolio of hotels and resorts. Its business spans full-service luxury and lifestyle properties, select- and focused-service hotels, and extended-stay accommodations. The company generates revenue through management and franchise fees, owned and leased real estate, and guest services, and supports customer retention and direct bookings through its Hilton Honors guest loyalty program. Hilton’s brand portfolio includes internationally recognized names across the lodging spectrum, from luxury and upper-upscale brands to midscale and extended-stay offerings. Featured Stories Five stocks we like better than Hilton Worldwide Want to see what other hedge funds are holding HLT? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Hilton Worldwide Holdings Inc. (NYSE:HLT – Free Report). Receive News & Ratings for Hilton Worldwide Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Hilton Worldwide and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINEAllspring Global Investments Holdings LLC Has $70.06 Million Stock Position in Costco Wholesale Corporation $COST NEXT HEADLINE »Econ Financial Services Corp Takes $3.82 Million Position in Lowe’s Companies, Inc. $LOW |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-04-08 12:31
3mo ago
|
3D Systems (DDD) Down 25.7% Since Last Earnings Report: Can It Rebound? | FMP Stock News | |
|
Original source text
It has been about a month since the last earnings report for 3D Systems (DDD - Free Report) . Shares have lost about 25.7% in that time frame, underperforming the S&P 500.Will the recent negative trend continue leading up to its next earnings release, or is 3D Systems due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. 3D Systems Posts Narrower Loss in Q4 Earnings, Revenues Rise Y/Y3D Systems reported a fourth-quarter 2025 non-GAAP loss of 13 cents per share, narrower than the reported loss of 19 cents per share in the year-ago quarter. The Zacks Consensus Estimate was pegged at a loss of 11 cents per share. DDD reported revenues of $106.3 million, down 4.3% year over year but up 16% on a sequential basis. The top line beat the Zacks Consensus Estimate by 7.87%. DDD’s Q4 Quarterly DetailsProduct revenues declined 11.2% year over year to $62.6 million in the fourth quarter, contributing 59% to total revenues. Services revenues, which accounted for 41% of total revenues, increased 7.7% year over year to $43.7 million. The company operates through two key segments — Healthcare Solutions and Industrial Solutions — tailored to the diverse industries it serves. Healthcare Solutions focuses on dental, medical devices, personalized health services and regenerative medicine, whereas Industrial Solutions caters to aerospace, defense, transportation and general manufacturing. In the fourth quarter, Healthcare Solutions’ revenues increased 25% year over year to $50.5 million. MedTech increased more than 8% year over year. Industrial Solutions' revenues declined 21.1% year over year to $55.8 million. Aerospace and Defense grew 50% year over year. DDD Q4 Operating DetailsIn the fourth quarter of 2025, DDD’s non-GAAP gross profit fell 5% year over year to $33 million. The non-GAAP gross profit margin declined 30 basis points to 31% due to lower sales volumes. Adjusted EBITDA loss of $5.3 million in the fourth quarter of 2025 was narrower than the loss of $19.1 million reported in the year-ago quarter. Non-GAAP operating expense was $42.5 million compared with $58.4 million reported in the year-ago quarter. 3D Systems’ Balance Sheet DetailsAs of Dec. 31, 2025, cash and cash equivalents were $97.1 million, higher than $95.5 million as of Sept. 30, 2025. As of Dec. 31, 2025, DDD had a total debt of $90.3 million. A total of $3.9 million in debt is scheduled to mature in the fourth quarter of 2026, with the remaining $92 million maturing in 2030. DDD Offers Positive Q1 Guidance3D Systems expects revenues between $91 million and $94 million for the first quarter of 2026. Adjusted EBITDA loss is expected between $5 million and $3 million. How Have Estimates Been Moving Since Then?Since the earnings release, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted -22.73% due to these changes. VGM ScoresCurrently, 3D Systems has a average Growth Score of C, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a score of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. OutlookEstimates have been trending upward for the stock, and the magnitude of this revision has been net zero. Notably, 3D Systems has a Zacks Rank #4 (Sell). We expect a below average return from the stock in the next few months. |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-04-13 07:30
3mo ago
|
3D Systems Accelerates Production-Scale Additive Manufacturing with New High-Throughput Platform and Next-Generation Factory Software | FMP Stock News | |
|
Original source text
Advancements to be Unveiled at RAPID + TCT 2026 in Boston April 13, 2026 07:30 ET | Source: 3D Systems Inc.Key Highlights Introduces SLA® 825 Dual, a next-generation dual-laser production system now available world-wide, delivering over 20% larger build volumes and up to 30% faster print speeds versus competitive systems, enabling higher throughput for precision production applications.Launches AddiTrak™, an advanced integrated software platform for 3D Systems additive manufacturing, delivering secure, on-premises, real-time fleet monitoring, process control, data collection, and customizable analytics.3D Systems’ comprehensive range of technologies and application expertise enabling real-world production adoption across metals and polymers, driven by accelerating customer demand in aerospace & defense, automotive, healthcare, and industrial markets. ROCK HILL, S.C., April 13, 2026 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced new hardware, software, and applications that are enabling customers to scale additive manufacturing into production environments requiring high throughput, reliability, repeatability, and process control. At RAPID + TCT 2026 (Booth #1801), 3D Systems will introduce the new SLA 825 Dual to the U.S. market, a next-generation stereolithography system engineered to significantly increase production output while maintaining the accuracy and consistency required for industrial manufacturing. The company will also debut AddiTrak™, a factory-floor software platform purpose-built for managing connected 3D Systems production environments. These innovations reinforce 3D Systems’ strategy to deliver production-ready additive manufacturing solutions that integrate hardware, software, materials, and application expertise to help customers move beyond prototyping and into scaled manufacturing. Maximizing SLA Speed, Productivity, and Consistency with SLA 825 Dual The SLA 825 Dual features a 22% larger build volume and delivers up to 25% faster build speeds than its predecessor, enabling customers to run more builds per shift and consolidate more parts per platform. Designed for high-utilization environments, the system supports demanding applications such as motorsports, full-scale precision prototyping, and investment casting patterns, where yield, dimensional accuracy, and repeatability are critical. By combining higher throughput with proven SLA precision, the SLA 825 Dual provides manufacturers with a scalable solution for transitioning stereolithography into high volume production workflows. Driving Fleet Visibility and Factory Efficiency with AddiTrak™ As additive manufacturing scales, fleet-level visibility and process control become essential to maintaining productivity, quality, and on-time delivery in production environments. To address these needs, 3D Systems is introducing AddiTrak, a secure, on-premises software platform designed specifically for the entire range of 3D Systems printers and accompanying workflows. AddiTrak provides centralized monitoring, analytics, and optimization across the production floor through a unified dashboard, while supporting Industry 4.0-compatible connectivity including MTConnect and OPC UA. AddiTrak is fully native to the 3D Systems ecosystem and integrates seamlessly with 3D Sprint®, enabling a connected, end-to-end workflow—from job preparation and scheduling through build execution and performance analysis—across the entire printing fleet. Customers can rely on security of their sensitive design and process data, as AddiTrak is fully on-premises and under their control, through all stages of the manufacturing process. Presenting Real-World Production Examples 3D Systems will also highlight customer application examples which demonstrate additive manufacturing supporting production. One of these is Eureka Pumps AS, based in Norway, which has partnered with 3D Systems to manufacture large-format metal spare parts on demand, using 3D Systems Direct Metal Printing (DMP) technology. This production model helps address part obsolescence, extended lead times, and inventory constraints, illustrating how additive manufacturing can strengthen supply chain resilience and responsiveness, while reducing working capital needs, in mission-critical industrial environments. By pairing advanced printing platforms with specialized materials, software, and application development expertise, 3D Systems continues to rapidly expand the range of production problems that additive manufacturing can solve. “The industrialization of additive manufacturing continues to accelerate as more companies realize its ability to deliver both performance gains through design innovation and operational flexibility through digital production,” said Patrick Dunne, SVP, Technical Fellow, 3D Systems. CEO Commentary “Over the past several years, we’ve made disciplined investments to refresh our portfolio and focus on manufacturing applications where additive delivers the greatest value,” said Dr. Jeff Graves, President and CEO, 3D Systems. “At RAPID + TCT 2026, we’re demonstrating how those investments are translating into production-focused solutions, from high-throughput stereolithography to connected software platforms that improve visibility and control across the full range of factory environments. These capabilities position our customers to apply additive manufacturing where precision, productivity, and part complexity matter most.” Experience 3D Systems at RAPID + TCT 2026 3D Systems will showcase these innovations and its application-focused portfolio at Booth #1801 during RAPID + TCT 2026, held April 13–16, 2026, in Boston, Massachusetts. Conference attendees are also invited to attend the following presentations: Steve Hartung – Pixels to 3D Printed Investment Casting Patterns, Tuesday, April 14, 2026, 1:30 PM, Tech Hub Stage, Booth #1531Joe Wisnewski – AddiTrak™, Tuesday, April 14, 2026, 3:30 PM, Tech Hub Stage, Booth #1531Panel: Life-Saver: How AM is Transforming Point-of-Care, including Dr. Jeff Graves, Wednesday, April 15, 2026, 8:30 AM, SME Main Stage Forward-Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise. About 3D Systems For nearly 40 years, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the company is available at www.3dsystems.com. Investor Contact: [email protected] Media Contact: [email protected] |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-04-28 07:30
2mo ago
|
3D Systems Secures Class IIa EU MDR Certification for NextDent® Jetted Denture Solution, Enabling Full European Commercial Launch Two Months Ahead of Schedule | FMP Stock News | |
|
Original source text
April 28, 2026 07:30 ET | Source: 3D Systems Inc.European commercial availability begins May 4, 2026, two months ahead of the previously targeted summer launchCertification expands the addressable market for the Company’s flagship dental printing platform to over 60 million edentulous patients across the US and EU, representing a multi-billion dollar denture marketEarly feedback from the U.S. market launch highlights strong patient satisfaction with denture aesthetics, comfort, and performance using NextDent 300 technology ROCK HILL, S.C., April 28, 2026 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced that its NextDent® Jet Base and NextDent® Jet Teeth materials, together with the NextDent 300 MultiJet 3D printer, have received Class IIa certification under the European Union Medical Device Regulation (MDR 2017/745). This regulatory milestone enables immediate commercialization of the complete NextDent Jetted Denture Solution across the EU. This achievement builds directly on the Company’s full-scope EU MDR certification announced in March 2026 and demonstrates 3D Systems’ leadership in meeting Europe’s most stringent quality, safety, and clinical evidence requirements for moderate-risk medical devices. The NextDent Jetted Denture Solution is the industry’s first monolithic, multi-material jetted denture workflow. Powered by the NextDent 300 printer and the newly certified Jet Base and Jet Teeth materials, it enables dental labs to produce durable, highly aesthetic, patient-specific monolithic dentures in a single print, fully cured and ready for finishing without additional post-curing steps. This breakthrough delivers superior accuracy, consistency, and production speed compared to traditional analog methods, reinforcing 3D Systems’ leadership across the full spectrum of dentistry: straighten, protect, repair, and replace. Jeffrey Graves, Ph.D., President and Chief Executive Officer of 3D Systems, stated: “Achieving Class IIa MDR certification for our NextDent Jetted Denture Solution is a major milestone that validates the strength of our clinical data, quality systems, and innovation pipeline. By launching in Europe on May 4, well ahead of our original summer timeline, we are immediately expanding access to this transformative technology for dental labs and clinics across the region. This clearance substantially increases our available addressable market for this high-value platform. As adoption accelerates in both the U.S. and Europe, we expect it to drive significant recurring revenue through premium materials while reinforcing our position as the leading full-service provider in digital dentistry.” According to internal estimates and market data, the European denture segment represents a multi-billion-dollar opportunity. With this certification, European customers can now access a complete, regulatory-compliant workflow, hardware, certified materials, software, and application expertise, from a single trusted partner. The NextDent 300 MultiJet printer and associated NextDent Jet Base and Jet Teeth materials will be commercially available in EU markets beginning May 4, 2026, through 3D Systems and its authorized distribution partners. For more information about the NextDent Jetted Denture Solution, visit: www.3dsystems.com/dental-jetted-dentures About 3D Systems For nearly 40 years, 3D Systems has pioneered additive manufacturing solutions that transform how products are designed, prototyped, and produced. As a full-service solutions partner, the Company delivers industry-leading 3D printing technologies, materials, software, and expert application support to high-value markets including medical and dental, aerospace & defense, transportation, and durable goods. More information is available at www.3dsystems.com. Forward-Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the timing of product launches, regulatory approvals, market opportunities, expected revenue impact, and shareholder value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise. Investor Contact: [email protected] Media Contact: [email protected] |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-04-30 07:00
2mo ago
|
3D Systems Announces Date of First Quarter 2026 Financial Results | FMP Stock News | |
|
Original source text
April 30, 2026 07:00 ET | Source: 3D Systems Inc.ROCK HILL, S.C., April 30, 2026 (GLOBE NEWSWIRE) -- 3D Systems (NYSE:DDD) announced today it will release its financial results for the first quarter 2026 after the U.S. stock market closes on Monday, May 11, 2026. The company will hold a conference call and simultaneous webcast to discuss these financial results on Tuesday, May 12, 2026 at 8:30 a.m. Eastern Time. First Quarter 2026 Financial Results Conference Call Date: Tuesday, May 12, 2026 Time: 8:30 a.m. Eastern Time Listen via webcast: www.3dsystems.com/investor Participate via telephone: 201-689-8345 or 877-407-8291 The webcast replay will be available approximately two hours after the end of the conference call at www.3dsystems.com/investor. About 3D Systems For nearly 40 years, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the company is available at www.3dsystems.com. Investor Contact: [email protected] Media Contact: [email protected] |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-07 16:30
2mo ago
|
New Cadillac Formula 1® Team Deploys 3D Systems’ SLA Technology To Achieve 2026 Debut | FMP Stock News | |
|
Original source text
May 07, 2026 16:30 ET | Source: 3D Systems Inc.New American Formula 1™ team selected seven 3D Systems SLA systems to accelerate critical wind tunnel testing and parts production prior to its 2026 Formula 1™ race debutIndustry-leading SLA materials portfolio is enabling accurate and rapid production of test parts3D Systems’ tightly integrated software, materials and machines, plus expert assistance by 3D Systems, allowed Team to “Race to the Race” ROCK HILL, S.C., May 07, 2026 (GLOBE NEWSWIRE) -- Today, 3D Systems (NYSE:DDD) announced that Cadillac Formula 1® Team, the newest entrant to the FIA FORMULA ONE WORLD CHAMPIONSHIP, deployed seven SLA 3D printing systems to accelerate critical wind tunnel testing prior to the 2026 FORMULA 1 season, as well as the development of production parts. The combination of these large format additive manufacturing systems, integrated with 3D Systems software, along with Accura® Xtreme White 200, Accura Xtreme Black and Accura HPC materials, enabled rapid and critical wind tunnel testing within rapidly diminishing race deadlines. 3D Systems’ SLA solutions are developed specifically for efficient, high-quality production-grade manufacturing delivering the best in sharp part corners, small extruded and embossed feature details, superior side wall details and smooth layer lines on angled faces in its class. It enables tool-free manufacturing, eliminating weeks of lead time and significantly reducing costs. This was a critical factor while the Cadillac Formula 1® Team qualified for the FIA FORMULA ONE WORLD CHAMPIONSHIP and continues to be essential for continued race car development. The FIA FORMULA ONE WORLD CHAMPIONSHIP is described by Racecar Engineering magazine as “the greatest challenge a manufacturer of mechanical components may ever be confronted with1.” Indeed, FORMULA 1 racing operates under some of the most stringent technical requirements in all of motorsport. The Cadillac Formula 1® Team worked hard to meet the barriers to entry and secured its place in the 2026 FORMULA 1 season in time for the FORMULA 1 QATAR AIRWAYS AUSTRALIAN GRAND PRIX 2026 in March. To achieve this, the team worked with 3D Systems’ Application Innovation Group (AIG), a global team of Additive Manufacturing engineers, designers, and technicians who bring expertise to customers to co-develop solutions. “3D Systems was founded on innovation, pioneering the additive manufacturing industry and we are continuing to lead it into an era of high-precision, highly repeatable production at scale,” said Elvis Perez, Senior Vice President, Sales, 3D Systems. “We are pleased that our work has enabled Cadillac Formula 1® team to enter the 2026 FORMULA 1 season despite the short timelines and strict qualification conditions.” About 3D Systems For nearly 40 years, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the company is available at www.3dsystems.com. Forward-Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the timing of product launches, regulatory approvals, market opportunities, expected revenue impact, and shareholder value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise. Investor Contact: [email protected] Media Contact: [email protected] 1 “Running a Race car,” 2023, Racecar Engineering magazine. |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-11 07:30
2mo ago
|
ROE Dental Laboratory Becomes First U.S. Lab to Deploy an Extensive Fleet of 3D Systems Jetted-Denture Printing Systems Across Multiple Sites | FMP Stock News | |
|
Original source text
May 11, 2026 07:30 ET | Source: 3D Systems Inc.ROE triples its manufacturing capacity for high-precision, multi-material monolithic dentures, capitalizing on early success with the NextDent® 300 jetted-denture solution to meet accelerating U.S. demand.Expansion highlights rapid commercial adoption of 3D Systems’ industry-first multi-material Jetted Denture Solution.Reinforces 3D Systems’ leadership in digital dentistry as labs shift from conventional methods to scalable, high-margin digital workflows. ROCK HILL, S.C., May 11, 2026 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced that ROE Dental Laboratory, one of the nation’s premier full-service dental labs, has purchased additional NextDent® 300 3D printers to expand its digital denture manufacturing capacity. With multiple systems in multiple locations now coming online, ROE becomes the leading dental laboratory in the U.S. to scale at this pace with the NextDent Jetted Denture Solution, dramatically increasing throughput and validating the platform for digital denture production. This fleet expansion enables ROE to triple production capacity for next-generation jetted dentures, meeting strong clinician demand for faster turnaround, superior fit, and attractive aesthetic outcomes. NextDent 300: The Industry’s First True Multi-Material Jetted Denture Platform The NextDent 300 powers 3D Systems’ breakthrough Jetted Denture Solution — the only system capable of producing monolithic dentures (base + teeth in one print) using two specialized materials in a single build. Key advantages include: Exceptional precision and fit with minimal post-processing.Multi-material jetting: NextDent Jet Base (high-impact, four shades) + NextDent Jet Teeth (rigid, esthetic, wear resistant, color-blended).High-volume output with limited hands-on labor.Full digital workflow: Seamless integration with leading CAD software for streamlined design-to-delivery. This technology replaces labor-intensive traditional processes with a repeatable, scalable digital solution, reducing costs, improving fit and product consistency, and shortening turnaround times. ROE Positions Itself at the Forefront of Digital Denture Innovation ROE Dental Laboratory has long been an early leader in digital dentistry. Its rapid expansion of NextDent 300 systems since product launch in the Fall of 2025 demonstrates strong confidence in the platform’s clinical and operational performance. “The NextDent 300 has exceeded our expectations in production efficiency, dentist acceptance, and patient satisfaction. Adding more systems at this early stage allows us to triple output while maintaining the high standards of quality and consistency. Being first to scale this technology gives us a competitive edge.” said BJ Kowalski, CEO of ROE Dental Laboratory. 3D Systems Strengthens Leadership in High-Growth Digital Dentistry ROE’s aggressive adoption underscores the momentum behind 3D Systems’ digital dentistry portfolio. As more labs modernize, the NextDent platform is emerging as the preferred solution for high-volume, high-precision denture manufacturing. With U.S. and EU regulatory approvals now in place, the combined addressable market exceeds 60 million edentulous patients, representing a multi-billion-dollar opportunity. “ROE’s rapid expansion of NextDent 300 systems is powerful validation of our Jetted Denture Solution,” said Jeff Graves, President and CEO of 3D Systems. “This technology is transforming denture production from a craft into a scalable, profitable digital workflow. Labs can now deliver a superior product with shorter lead times, getting better solutions to patients faster and more economically than ever before. We’re excited to support innovators like ROE as they capitalize on this shift.” For more information about the NextDent Jetted Denture Solution, visit: www.3dsystems.com/dental-jetted-dentures About 3D Systems For nearly 40 years, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the company is available at www.3dsystems.com. Forward-Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the timing of product launches, regulatory approvals, market opportunities, expected revenue impact, and shareholder value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise. Investor Contact: [email protected] Media Contact: [email protected] |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-11 17:09
2mo ago
|
3D Systems Reports First Quarter 2026 Financial Results | FMP Stock News | |
|
Original source text
ROCK HILL, S.C., May 11, 2026 (GLOBE NEWSWIRE) -- 3D Systems Corporation (NYSE:DDD) announced today its financial results for the first quarter ended March 31, 2026.Q1 2026 revenue of $95.5 million increased 1% year-over-year, or 11% excluding the impact of divestitures, driven by strong performance in the Healthcare business and double‑digit growth across key markets, including Dental, Med Tech, and Aerospace & Defense.GAAP EPS loss narrowed to $(0.03), or $(0.01) on a non-GAAP basis, while Adjusted EBITDA improved to $2.1 million, reflecting the benefits of higher sales volumes and continued execution of cost reduction initiatives.Robust growth in Dental and Med Tech, each exceeding approximately 20% year-over-year, drove Healthcare to a scale that now rivals the Company's Industrial segment.Early success of recently launched products in Dental and Aerospace & Defense markets, including advanced printing systems for monolithic dentures and high‑performance metal components, is expected to support sustained long‑term revenue growth.Amid ongoing global risks, the Company remains focused on building top-line momentum in key markets over the coming quarters, while maintaining disciplined cost management to achieve our goal of full-year break-even Adjusted EBITDA. Summary of Financial Results (Unaudited) Three Months Ended(in millions, except per share data) March 31, 2026 March 31, 2025Revenue $95.5 $94.5 Gross profit 34.3 32.7 Gross profit margin 35.9 % 34.6 %Operating expense 41.0 69.5 Operating loss (6.6) (36.8)Net loss attributable to 3D Systems Corporation (4.4) (37.0)Diluted loss per share (0.03) (0.28) Non-GAAP measures for year-over-year comparisons Non-GAAP gross profit margin 36.1 % 35.0 %Non-GAAP operating expense 36.6 61.6 Adjusted EBITDA 2.1 (23.9)Non-GAAP diluted loss per share $(0.01) $(0.21) Summary Comments on Results Dr. Jeffrey Graves, President and Chief Executive Officer of 3D Systems, said, “We are pleased with our first‑quarter performance on both the top and bottom line, which exceeded our initial expectations. Revenue growth was driven by strength in our key markets, including Dental, Med Tech, and Aerospace & Defense. These customers continue to rapidly adopt 3D printing as a core manufacturing technology and expand the range of applications they deploy. In the first quarter, this momentum drove growth rates of more than 20% in our Dental (excluding aligners), Med Tech, and Aerospace & Defense markets. This performance highlights the market‑leading breadth of our additive manufacturing portfolio, spanning direct metal printing and all five major polymer technologies, combined with our deep expertise in advanced applications.” Dr. Graves concluded, “As the additive manufacturing industry begins to emerge from a multi‑year downturn, our sustained investments in research and development are enabling us to introduce a broad pipeline of new products that are gaining increasing customer traction. While the global economic environment remains uncertain, we are optimistic that, as capital investment activity strengthens, we are well positioned to benefit from the resulting expansion in global manufacturing capacity.” “Adjusting for divestitures completed in 2025, total revenue increased 11% year over year, demonstrating a return of core revenue growth as we move into 2026” said Phyllis Nordstrom, Chief Financial Officer of 3D Systems. “Strong sales across key product areas, along with a focus on margin expansion, profitability, and efficient cost management, positively contributed to our performance in the quarter. We remain committed to managing costs while making targeted investments in our priority markets to drive profitable growth.” First Quarter 2026 Results Total revenue increased 1% to $95.5 million compared to the prior year period. Adjusting for software divestitures completed in 2025, including Geomagic, 3DXpert and Oqton, total revenue increased by 11%. Healthcare Solutions revenue increased approximately 21% to $50.1 million compared to the prior year period. Industrial Solutions revenue decreased approximately 15% to $45.4 million compared to the prior year period. Adjusting for divestitures, Industrial Solutions revenue increased 2% year over year. Gross profit margin increased to 35.9% compared to 34.6% in the prior year period. Non-GAAP gross profit margin increased to 36.1% compared to 35.0% in the prior year period. Adjusting for software divestitures, non-GAAP gross profit margin increased by 600 basis points. Net loss attributable to 3D Systems Corporation decreased by $32.6 million to $4.4 million compared to the prior year period. The improvement was primarily driven by lower operating expenses, higher sales volume, and favorable revenue mix. Adjusted EBITDA turned positive, improving by $25.9 million to $2.1 million compared to the prior year period, driven by strong sales, favorable revenue mix, and the impact of prior cost reduction actions. Adjusting for software divestitures, Adjusted EBITDA improved $28.2 million. Financial Liquidity At March 31, 2026, the Company had total cash of $86.5 million, which included cash and cash equivalents of $85.1 million and restricted cash of $1.4 million. A total of $3.9 million in principal amount of debt is scheduled to mature in the fourth quarter of 2026, with the remaining $92.0 million principal maturing in 2030. Second Quarter 2026 Outlook Revenue: $93 - $95 million Adjusted EBITDA: ($4) million - ($2) million 3D Systems does not provide forward-looking guidance for certain measures on a GAAP basis. The Company is unable to provide a quantitative reconciliation of forward-looking Adjusted EBITDA to the most directly comparable forward-looking GAAP measures without unreasonable effort because certain items, including litigation expenses, acquisition expenses, stock-based compensation expense, intangible amortization expense, restructuring expenses, and goodwill impairment, are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the Company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially. First Quarter 2026 Conference Call and Webcast The Company will host a conference call and simultaneous webcast to discuss these results on May 12, 2026, which may be accessed as follows: Date: Tuesday, May 12, 2026 Time: 8:30 a.m. Eastern Time Listen via webcast: www.3dsystems.com/investor Participate via telephone: 877-407-8291 or 201-689-8345 A replay of the webcast will be available approximately two hours after the live presentation at www.3dsystems.com/investor. Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the timing of product launches, regulatory approvals, market opportunities, expected revenue impact, and shareholder value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the Company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the Company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the Company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise. About 3D Systems Nearly 40 years ago, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the Company is available at www.3dsystems.com. Investor Contact: [email protected] Media Contact: [email protected] 3D SYSTEMS CORPORATION Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except par value) March 31, 2026 December 31, 2025ASSETS Current assets: Cash and cash equivalents $85,083 $95,635 Accounts receivable, net of reserves — $4,001 and $3,608 86,237 83,806 Inventories 127,265 127,496 Prepaid expenses and other current assets 42,075 39,770 Total current assets 340,660 346,707 Property and equipment, net 49,023 49,249 Intangible assets, net 16,157 16,614 Goodwill 15,454 15,575 Operating lease right-of-use assets 42,387 45,364 Finance lease right-of-use assets 7,537 7,774 Long-term deferred income tax assets 2,511 2,787 Other assets 39,387 37,658 Total assets $513,116 $521,728 LIABILITIES, REDEEMABLE NON-CONTROLLING INTEREST AND EQUITY Current liabilities: Current portion of long-term debt, net of deferred financing costs $3,944 $3,944 Current operating lease liabilities 10,939 11,583 Accounts payable 39,397 41,017 Accrued and other liabilities 49,113 46,656 Customer deposits and deferred revenue 20,020 17,423 Total current liabilities 123,413 120,623 Long-term debt, net of deferred financing costs 86,786 86,394 Long-term operating lease liabilities 42,481 45,420 Long-term deferred income tax liabilities 3,009 2,740 Other liabilities 23,083 24,000 Total liabilities 278,772 279,177 Commitments and contingencies Redeemable non-controlling interest — 2,193 Stockholders’ equity: Preferred stock, 5,000 shares authorized; $0.001 par value; no shares issued and outstanding as of March 31, 2026 and December 31, 2025 — — Common stock, $0.001 par value, authorized 220,000 shares; shares issued 146,057 and 145,581 as of March 31, 2026 and December 31, 2025, respectively 146 146 Additional paid-in capital 1,622,692 1,620,399 Accumulated deficit (1,336,784) (1,332,360)Accumulated other comprehensive loss (51,710) (47,827)Total stockholders’ equity 234,344 240,358 Total liabilities, redeemable non-controlling interest and stockholders’ equity $513,116 $521,728 3D SYSTEMS CORPORATION Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended(in thousands, except per share amounts) March 31, 2026 March 31, 2025Revenue: Products $57,768 $54,723 Services 37,770 39,817 Total revenue 95,538 94,540 Cost of sales: Products 36,087 37,365 Services 25,108 24,486 Total cost of sales 61,195 61,851 Gross profit 34,343 32,689 Operating expenses: Selling, general and administrative 31,348 49,769 Research and development 9,635 19,683 Total operating expenses 40,983 69,452 Loss from operations (6,640) (36,763)Non-operating income (loss): Foreign exchange gain, net 2,638 1,139 Interest income 584 953 Interest expense (2,164) (581)Other income (loss), net 3,528 (160) Total non-operating income 4,586 1,351 Net loss before income taxes (2,054) (35,412)Provision for income taxes (1,483) (671)Loss on equity method investments, net of income taxes (1,046) (903)Net loss before redeemable non-controlling interest (4,583) (36,986)Less: net loss attributable to redeemable non-controlling interest (159) — Net loss attributable to 3D Systems Corporation $(4,424) $(36,986) Net loss per common share: Basic $(0.03) $(0.28)Diluted $(0.03) $(0.28) Weighted average shares outstanding: Basic 143,261 132,462 Diluted 143,261 132,462 3D SYSTEMS CORPORATION Condensed Consolidated Statements of Cash Flows (Unaudited) Three Months Ended(in thousands) March 31, 2026 March 31, 2025OPERATING ACTIVITIES Net loss before redeemable non-controlling interest $(4,583) $(36,986)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 5,132 5,712 Amortization of debt issuance costs 499 316 Stock-based compensation 2,282 4,168 Non-cash operating lease expense 3,022 2,371 Provision for inventory obsolescence 1,431 1,311 Provision for bad debts 473 325 (Gain) loss on the disposition of businesses, property, equipment and other assets (320) 128 Provision for deferred income taxes and reserve adjustments 690 1,652 Gain on disposal of investment (2,576) — Loss on equity method investment, net of taxes 1,046 903 Changes in operating accounts: Accounts receivable (5,645) (1,231) Inventories (2,146) (1,870) Prepaid expenses and other current assets (2,014) (4,078) Accounts payable (2,040) (2,799) Deferred revenue and customer deposits 4,759 5,745 Accrued and other liabilities 109 (4,144)All other operating activities (7,331) (5,309)Net cash used in operating activities (7,212) (33,786)INVESTING ACTIVITIES Purchases of property and equipment (2,058) (2,795)Proceeds from sale of assets and businesses, net of cash sold 100 — Acquisitions and other investments, net of cash acquired — (550)Other investing activities (202) (67)Net cash used in investing activities (2,160) (3,412)FINANCING ACTIVITIES Purchase of non-controlling interest (498) — Taxes paid related to net-share settlement of equity awards (11) (285)Other financing activities (414) (364)Net cash used in financing activities (923) (649)Effect of exchange rate changes on cash, cash equivalents and restricted cash (289) 1,178 Net decrease in cash, cash equivalents and restricted cash (10,584) (36,669)Cash, cash equivalents and restricted cash at the beginning of the year 97,100 172,883 Cash, cash equivalents and restricted cash at the end of the period $86,516 $136,214 3D SYSTEMS CORPORATION Segment Information (Unaudited) Three Months Ended (in millions) March 31, 2026 March 31, 2025 Revenue: Healthcare Solutions $50.1 $41.3 Industrial Solutions 45.4 53.2 Total $95.5 $94.5 3D SYSTEMS CORPORATION Reconciliations of GAAP to Non-GAAP Measures Presentation of Information in this Press Release 3D Systems reports its financial results in accordance with GAAP. Management also reviews and reports certain non-GAAP measures, including: non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP diluted income (loss) per share, non-GAAP operating expense and Adjusted EBITDA. These non-GAAP measures exclude certain items that management does not view as part of 3D Systems’ core results as they may be highly variable, may be unusual or infrequent, are difficult to predict and can distort underlying business trends and results. Management believes that the non-GAAP measures provide useful additional insight into underlying business trends and results and provide meaningful information regarding the comparison of period-over-period results. Additionally, management uses the non-GAAP measures for planning, forecasting and evaluating business and financial performance, including allocating resources and evaluating results relative to employee compensation targets. 3D Systems’ non-GAAP measures are not calculated in accordance with or as required by GAAP and may not be calculated in the same manner as similarly titled measures used by other companies. These non-GAAP measures should thus be considered as supplemental in nature and not considered in isolation or as a substitute for the related financial information prepared in accordance with GAAP. To calculate the non-GAAP measures, 3D Systems excludes the impact of the following items: amortization of intangible assets, a non-cash expense, as 3D Systems’ intangible assets were primarily acquired in connection with business combinations;costs incurred in connection with acquisitions and divestitures, such as legal, consulting and advisory fees;stock-based compensation expenses, a non-cash expense;charges related to restructuring and cost optimization plans, impairment charges, including goodwill, and divestiture gains or losses;the impact of software divestitures, which were previously included in our Industrial Solutions segment, for pre-divestiture periods in 2025; andcosts, including legal fees, related to significant or unusual litigation matters. Amortization of intangibles and acquisition and divestiture-related costs are excluded from non-GAAP measures as the timing and magnitude of business combination transactions are not predictable, can vary significantly from period to period and the purchase price allocated to amortizable intangible assets and the related amortization period are unique to each acquisition. Amortization of intangible assets will recur in future periods until such intangible assets have been fully amortized. While intangible assets contribute to the company’s revenue generation, the amortization of intangible assets does not directly relate to the sale of the company’s products or services. Additionally, intangible assets amortization expense typically fluctuates based on the size and timing of the company’s acquisition activity. Accordingly, the company believes excluding the amortization of intangible assets enhances the company’s and investors’ ability to compare the company’s past financial performance with its current performance and to analyze underlying business performance and trends. Although stock-based compensation is a key incentive offered to certain of our employees, the expense is non-cash in nature, and we continue to evaluate our business performance excluding stock-based compensation; therefore, it is excluded from non-GAAP measures. Stock-based compensation expenses will recur in future periods. Charges related to restructuring and cost optimization plans, impairment charges, including goodwill, divestiture gains or losses, and the costs, including legal fees, related to significant or unusual litigation matters are excluded from non-GAAP measures as the frequency and magnitude of these activities may vary widely from period to period. Additionally, impairment charges, including goodwill, are non-cash. Furthermore, the company believes the costs, including legal fees, related to significant or unusual litigation matters are not indicative of our core business' operations. Finally, 3D Systems excludes contingent consideration recorded as compensation expense related to the 2021 Volumetric acquisition from non-GAAP measures as management evaluates financial performance excluding this expense, which is viewed by management as similar to acquisition consideration. The matters discussed above are tax effected, as applicable, in calculating non-GAAP diluted income (loss) per share. Adjusted EBITDA, defined as net income, plus income tax (provision) benefit, interest and other income (expense), net, stock-based compensation expense, amortization of intangible assets, depreciation expense, and other non-GAAP adjustments, all as described above, is used by management to evaluate performance and helps measure financial performance period-over-period. Furthermore, in this press release, 3D Systems reports certain non-GAAP financial measures further adjusted to remove the operating activity related to (i) Geomagic, which the Company divested on April 1, 2025, for $119.4 million in cash, and (ii) 3DXpert and Oqton, which the Company divested on October 31, 2025, for $3.3 million in cash plus a revenue-based royalty of up to $12.9 million (together with Geomagic, the "Software Divestitures"), for periods non-comparable on a year over year basis. The Company believes excluding non-comparable periods allows it to include the operating activity related to Software Divestitures only to the extent that results are comparable year over year. A reconciliation of GAAP to non-GAAP financial measures is provided in the accompanying schedules. Certain columns may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying numbers in thousands. 3D Systems does not provide forward-looking guidance for certain measures on a GAAP basis. The Company is unable to provide a quantitative reconciliation of forward-looking Adjusted EBITDA to the most directly comparable forward-looking GAAP measure without unreasonable effort because certain items, including litigation costs, acquisition expenses, stock-based compensation expense, intangible assets amortization expense, restructuring expenses, and goodwill impairment charges, are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the Company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially. Adjusted Revenue (Unaudited) Three Months Ended(in millions) March 31, 2026 March 31, 2025Revenue $95.5 $94.5 Software divestitures — (8.5)Adjusted revenue (Non-GAAP) $95.5 $86.0 Non-GAAP Gross Profit and Gross Profit Margin (Unaudited) Three Months Ended(in millions) March 31, 2026 March 31, 2025 Gross Profit Gross Profit Margin(1) Gross Profit Gross Profit Margin(1)Gross profit (GAAP) $34.3 35.9% $32.7 34.6%Amortization expense 0.2 0.2% 0.2 0.2%Restructuring expense — —% 0.2 0.2%Asset impairment charges (0.1) (0.1)% — —%Gross profit (Non-GAAP) $34.4 36.1% $33.1 35.0%Software divestitures — —% (7.2) (4.9)%Gross profit excluding software divestitures (Non-GAAP) $34.4 36.1% $25.9 30.1% (1) Calculated as non-GAAP gross profit as a percentage of total revenue. Non-GAAP Operating Expense (Unaudited) Three Months Ended(in millions) March 31, 2026 March 31, 2025Operating expense (GAAP) $41.0 $69.5 Amortization expense (0.7) (0.8)Stock-based compensation expense (2.3) (4.2)Acquisition and divestiture-related expense (0.2) (0.9)Legal and other expense (1.1) (1.1)Restructuring expense (0.2) (0.8)Asset impairment charges 0.1 — Non-GAAP operating expense $36.6 $61.6 Software divestitures — (4.9)Non-GAAP operating expenses excluding software divestitures $— $56.7 Net Loss Attributable to 3D Systems Corporation to Adjusted EBITDA (Unaudited) Three Months Ended(in millions) March 31, 2026 March 31, 2025Net loss attributable to 3D Systems Corporation (GAAP) $(4.4) $(37.0)Interest expense (income), net 1.6 (0.4)Provision for income taxes 1.5 0.7 Depreciation expense 4.2 4.7 Amortization expense 0.9 1.0 EBITDA (Non-GAAP) 3.7 (31.0)Stock-based compensation expense 2.3 4.2 Acquisition and divestiture-related expense 0.2 0.9 Legal and other expense 1.1 1.1 Restructuring expense 0.2 1.0 Net loss attributable to redeemable non-controlling interest (0.2) — Loss on equity method investment, net of tax 1.0 0.9 Gain on disposal of investment (2.6) — Other non-operating income (3.8) (1.0)Adjusted EBITDA (Non-GAAP) $2.1 $(23.9)Software divestitures — (2.2)Adjusted EBITDA (Non-GAAP) excluding software divestitures $2.1 $(26.1) Diluted Loss per Share (Unaudited) Three Months Ended(in dollars) March 31, 2026 March 31, 2025Diluted loss per share (GAAP) $(0.03) $(0.28)Amortization expense 0.01 0.01 Stock-based compensation expense 0.02 0.03 Acquisition and divestiture-related expense — 0.01 Legal and other expense 0.01 0.01 Restructuring expense — 0.01 Gain on disposal of investment (0.02) — Loss on equity method investment and other 0.01 0.01 Non-GAAP diluted loss per share $(0.01) $(0.21) |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-11 21:06
2mo ago
|
3D Systems (DDD) Reports Q1 Loss, Beats Revenue Estimates | FMP Stock News | |
|
Original source text
3D Systems (DDD - Free Report) came out with a quarterly loss of $0.01 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to a loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +88.89%. A quarter ago, it was expected that this maker of 3D printers would post a loss of $0.11 per share when it actually produced a loss of $0.13, delivering a surprise of -18.18%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. 3D Systems, which belongs to the Zacks Commercial Printing industry, posted revenues of $95.54 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 3.65%. This compares to year-ago revenues of $94.54 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. 3D Systems shares have added about 39.6% since the beginning of the year versus the S&P 500's gain of 8.1%. What's Next for 3D Systems?While 3D Systems has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for 3D Systems was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.09 on $94.95 million in revenues for the coming quarter and -$0.30 on $388.48 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Commercial Printing is currently in the bottom 13% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Research Solutions Inc. (RSSS - Free Report) , is yet to report results for the quarter ended March 2026. The results are expected to be released on May 14. This company is expected to post quarterly earnings of $0.04 per share in its upcoming report, which represents a year-over-year change of +33.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Research Solutions Inc.'s revenues are expected to be $12.48 million, down 1.4% from the year-ago quarter. |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-12 12:10
2mo ago
|
3D Systems Corporation (DDD) Q1 2026 Earnings Call Transcript | FMP Stock News | |
|
Original source text
3D Systems Corporation (DDD) Q1 2026 Earnings Call Transcript |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-12 13:56
2mo ago
|
3D Systems Q1 Earnings Beat Estimates, Revenues Increase Y/Y | FMP Stock News | |
|
Original source text
Key Takeaways DDD posted a Q1 non-GAAP loss of 1 cent per share, beating estimates as revenue rose 1% year over year. 3D Systems Healthcare revenue jumped 21%, driven by strong Dental and MedTech demand growth. DDD expects Q2 revenues of $93M-$95M and adjusted EBITDA loss between $2M and $4M. 3D Systems (DDD - Free Report) posted a first-quarter 2026 non-GAAP loss of 1 cent per share, narrower than the reported loss of 21 cents per share in the year-ago quarter. The figure beat the Zacks Consensus Estimate by 88.89%.Revenues were $95.5 million, up 1% year over year or 11% excluding the impact of divestitures and surpassed the Zacks Consensus Estimate by 3.65%. Strength in Healthcare demand stood out, supported by double-digit growth across Dental, Med Tech and Aerospace and Defense. Product revenues increased 5.5% year over year to $57.8 million in the first quarter, contributing 60.5% to total revenues. Services revenues, which accounted for 39.5% of total revenues, decreased 5.1% year over year to $37.8 million. DDD’s Q1 Segmental DetailsThe company operates through two key segments — Healthcare Solutions and Industrial Solutions — tailored to the diverse industries it serves. Healthcare Solutions focuses on dental, medical devices, personalized health services, and regenerative medicine, whereas Industrial Solutions caters to aerospace, defense, transportation and general manufacturing. Healthcare Solutions remained the clear driver of the quarter. Segment revenue increased about 21% year over year to $50.1 million, reflecting broad-based momentum across key medical and dental applications. Dental and MedTech increased approximately 20% year over year. Industrial Solutions, however, continued to face pressure. Segment revenue decreased roughly 15% year over year to $45.4 million, though the company noted that adjusting for 2025 divestitures, Industrial Solutions revenue increased 2% from the prior-year period. DDD Q1 Operating DetailsIn the first quarter of 2026, DDD’s non-GAAP gross profit increased 3.9% year over year to $34.4 million. The non-GAAP gross profit margin expanded 100 basis points to 36%, aided by higher volumes and a more favorable revenue mix. Adjusted EBITDA was $2.1 million compared with an adjusted EBITDA loss of $23.9 million a year ago, underscoring the benefits of improved sales levels and continued execution against expense initiatives. Operating expenses also came down sharply. Total operating expense on a non-GAAP basis declined 40.6% year over year to $36.6 million, reflecting the impact of earlier cost reduction actions. DDD’s Liquidity Declined as Cash Flow Stayed NegativeAs of March 31, 2026, total cash was $86.5 million, including $85.1 million of cash and cash equivalents and $1.4 million of restricted cash. As of March 31, 2026, DDD had a total debt of $90.7 million. The balance sheet also reflects $3.9 million of debt scheduled to mature in the fourth quarter of 2026, with $92.0 million maturing in 2030. 3D Systems’ Q2 View Implies Stable Revenue, EBITDA PullbackManagement expects second-quarter 2026 revenues in the range of $93 million to $95 million. The outlook implies roughly steady demand levels as the company works to build on the quarter’s top-line momentum in priority markets. On profitability, adjusted EBITDA is expected to be between a loss of $4 million and $2 million in the second quarter. DDD Zacks Rank & Stocks to ConsiderDDD currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader Zacks Industrial Products sector include RBC Bearings (RBC - Free Report) , Enersys (ENS - Free Report) , and EquipmentShare.com (EQPT - Free Report) . Each stock currently carries a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Shares of RBC Bearings have gained 36.8% in the year-to-date period. RBC Bearings is set to report fourth-quarter fiscal 2026 results on May 15. Enersys shares have gained 61.4% in the year-to-date period. Enersys is scheduled to report fourth-quarter fiscal 2026 results on May 20. EquipmentShare.com shares have lost 28.5% in the year-to-date period. EquipmentShare.com is set to report its first-quarter 2026 results on May 13. |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-12 16:10
2mo ago
|
3D Systems Q1 Earnings Call Highlights | FMP Stock News | |
|
Original source text
2 hours agoThe Progressive Corporation $PGR Shares Sold by Woodley Farra Manion Portfolio Management Inc.Woodley Farra Manion Portfolio Management Inc. lowered its stake in The Progressive Corporation (NYSE:PGR - Free Report) by 2.8% in the 4th quarter, according to its most recent Form 13F filing with the Securities & Exchange Commission. The firm owned 305,408 shares of the insurance provider's NYSE:PGR Read The Progressive Corporation $PGR Shares Sold by Woodley Farra Manion Portfolio Management Inc. 2 hours ago Woodley Farra Manion Portfolio Management Inc. Sells 16,282 Shares of The Walt Disney Company $DISMarketBeat Woodley Farra Manion Portfolio Management Inc. cut its holdings in shares of The Walt Disney Company (NYSE:DIS - Free Report) by 2.2% during the fourth quarter, according to its most recent disclosure with the Securities and Exchange Commission. The fund owned 708,928 shares of the entertainment gi NYSE:DIS Read Woodley Farra Manion Portfolio Management Inc. Sells 16,282 Shares of The Walt Disney Company $DIS 2 hours ago Morgan Stanley $MS Stock Position Cut by Woodley Farra Manion Portfolio Management Inc.MarketBeat Woodley Farra Manion Portfolio Management Inc. cut its holdings in shares of Morgan Stanley (NYSE:MS - Free Report) by 2.7% during the fourth quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The firm owned 556,628 shares of the financial servi NYSE:MS Read Morgan Stanley $MS Stock Position Cut by Woodley Farra Manion Portfolio Management Inc. 2 hours ago Xponance LLC Grows Position in Texas Instruments Incorporated $TXNMarketBeat Xponance LLC grew its position in shares of Texas Instruments Incorporated (NASDAQ:TXN - Free Report) by 7.7% during the 4th quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The fund owned 177,875 shares of the semiconductor company's stock after purchas NASDAQ:TXN Read Xponance LLC Grows Position in Texas Instruments Incorporated $TXN 2 hours ago Xponance LLC Acquires 152,351 Shares of AT&T Inc. $TMarketBeat Xponance LLC increased its holdings in shares of AT&T Inc. (NYSE:T - Free Report) by 14.4% in the fourth quarter, according to the company in its most recent filing with the SEC. The institutional investor owned 1,213,315 shares of the technology company's stock after purchasing an additional 152, NYSE:T Read Xponance LLC Acquires 152,351 Shares of AT&T Inc. $T Sort By Time Frame Alert Type Keywords Page 1 of 320 |
|||
|
Saved
2026-06-12 11:51
1mo ago
Published
2026-05-28 10:56
1mo ago
|
Should You Buy 3D Systems (DDD) After Golden Cross? | FMP Stock News | |
|
Original source text
From a technical perspective, 3D Systems Corporation (DDD - Free Report) is looking like an interesting pick, as it just reached a key level of support. DDD's 50-day simple moving average crossed above its 200-day simple moving average, which is known as a "golden cross" in the trading world.Considered an important signifier for a bullish breakout, a golden cross is a technical chart pattern that's formed when a stock's short-term moving average breaks above a longer-term moving average; the most common crossover involves the 50-day and the 200-day, since bigger time periods tend to form stronger breakouts. There are three stages to a golden cross. First, there must be a downtrend in a stock's price that eventually bottoms out. Then, the stock's shorter moving average crosses over its longer moving average, triggering a positive trend reversal. The third stage is when a stock continues the upward momentum to higher prices. This kind of chart pattern is the opposite of a death cross, which is a technical event that suggests future bearish price movement. DDD has rallied 63.9% over the past four weeks, and the company is a #2 (Buy) on the Zacks Rank at the moment. This combination indicates DDD could be poised for a breakout. The bullish case solidifies once investors consider DDD's positive earnings outlook. For the current quarter, no earnings estimate has been cut compared to 2 revisions higher in the past 60 days. The Zacks Consensus Estimate has increased too. Investors should think about putting DDDon their watchlist given the ultra-important technical indicator and positive move in earnings estimates. |
|||