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Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced that the U.S. Food and Drug Administration (FDA) has approved Hibsago(bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg) levels ≤3000 IU/ml, as determined by an FDA-authorized test. GSK licensed bepirovirsen from Ionis and collaborated with them on its development.

Bepirovirsen is a first in class RNA-targeted medicine that offers unprecedented functional cure rates compared to current standard of care. The approval was granted under FDA priority review and Breakthrough Therapy Designation, recognizing significant improvement of bepirovirsen and nucleos(t)ide analogue therapy over existing standard of care.

“About 1.7 million people in the U.S are living with chronic hepatitis B, and yet treatment options have been historically limited and the vast majority of people living with the chronic infection require lifetime care without achieving meaningful functional cure,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “We are pleased to see the FDA approval of Hibsago, which adds to a growing portfolio of transformative medicines discovered and developed by Ionis that address serious diseases, including many that previously had limited or no available treatment options. We believe Hibsago will bring new hope to people living with chronic hepatitis B, offering the potential to achieve unprecedented functional cure rates after a six-month treatment course.”

The approval was supported by results from the Phase 3 B-Well trials showing functional cure rates of 19% in adults with ≤3000 IU/ml HBsAg, compared to current standard of care alone, which typically achieves less than 1% functional cure rate after one year of treatment. Functional cure occurs when HBV DNA and HBsAg are undetectable for at least 24 weeks after stopping all treatment, indicating the disease is controlled by the immune system without medication.

“This is the start of a new era in treating people living with CHB,” said Norah Terrault, MD, MPH, FAASLD, Chief of Gastroenterology & Hepatology, USC Keck Medical Centre. “Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike."

“CHB is a major public health challenge, affecting millions of people in the U.S. and accounting for approximately 56% of all global liver cancer cases,” said Chari Cohen, DrPH, MPH, president, Hepatitis B Foundation. “Today marks significant progress towards our aim of transforming the way CHB is managed with improvements in screening, diagnosis, and the availability of innovative treatment options for our community.”

Quantitative surface antigen testing will support the diagnosis and identification of patients suitable for treatment with bepirovirsen who have baseline HBsAg levels ≤3000 IU/ml. Several tests are available, including a recently authorized FDA test.

GSK continues to advance regulatory submissions for bepirovirsen across multiple geographies with key regulatory decisions anticipated in the coming months.

GSK licensed bepirovirsen from Ionis in 2019 under a collaborative development and licensing agreement. Under the terms of the agreement, Ionis has received an upfront payment, license fee and development and regulatory milestone payments and is eligible to receive additional regulatory and sales milestone payments as well as tiered royalties of 10-12% on net sales of bepirovirsen.

Results from the Phase 3 B-Well trials

Pooled data from the Phase 3 B-Well trials showed that six-month treatment with bepirovirsen achieved a clinically meaningful 19% functional cure response rate (233 of 1,220 vs. 0 of 614 in the placebo group). B-Well 1 and B-Well 2 each met the primary endpoint, demonstrating a statistically significant improvement in functional cure versus placebo in the overall study population (adults with ≤3000 IU/ml HBsAg level). In a key secondary endpoint, a functional cure rate of 26% (200 of 768 vs. 0 of 393 in the placebo group) was achieved in participants with ≤1000 IU/ml HBsAg level, a group that represents approximately 45% of diagnosed CHB cases globally.

Exploratory analyses also showed bepirovirsen reduced HBsAg to ≤100 IU/ml in 49% of participants (598 of 1220) in the overall study population, and in 62% of bepirovirsen recipients in the ≤1000 IU/ml (476 of 768) sub-group as of the week 72 visit. Medical literature has linked this low level of surface antigen with increased immune control and improved patient outcomes.

The trials showed an acceptable safety and tolerability profile consistent with other studies of bepirovirsen. The three most frequently observed adverse events were injection site erythema, local pain and temporary rise in the blood level of a liver enzyme.

About bepirovirsen

Bepirovirsen is a non-GalNAc-conjugated antisense oligonucleotide (ASO) designed to recognize and inhibit the production of the genetic components (i.e., RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control. Bepirovirsen reduces the production of RNA and viral proteins associated with HBV, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and may stimulate the immune system to increase the chances of a durable and sustained response.

Bepirovirsen has been recognized by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B, with Breakthrough Designation and priority review from the U.S. FDA, Breakthrough Therapy and Priority Review designation in China and SENKU designation in Japan. Bepirovirsen is approved in Japan and the U.S.

INDICATION

HIBSAGO is indicated in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy to treat chronic hepatitis B virus (HBV) infection in adults without cirrhosis who have been on NrtI therapy for ≥6 months with suppressed HBV DNA and who have HBV surface antigen (HBsAg) levels ≤3,000 IU/mL as determined by an FDA-authorized test.

WARNING: ON-TREATMENT HEPATIC FLARES AND THROMBOCYTOPENIA

On-Treatment Hepatic Flares

HIBSAGO may cause on-treatment hepatic flares with increases in alanine aminotransferase (ALT) of >20-40x upper limit of normal (ULN) associated with decline in HBsAg. Some cases were associated with hyperbilirubinemia. Most occurred within the first 12 weeks and resolved when treatment was interrupted or discontinued. Do not initiate HIBSAGO in patients with evidence of acute hepatic impairment or cirrhosis. ALT and total bilirubin must be measured prior to treatment and frequently monitored during treatment. Treatment interruption, followed by dose reduction or discontinuation, may be necessary based on liver laboratory results.

Thrombocytopenia

HIBSAGO may cause reductions in platelet counts that may result in sudden and unpredictable thrombocytopenia, which can be life-threatening. Obtain platelet count prior to treatment; HIBSAGO is contraindicated in patients with platelet count

CONTRAINDICATIONS

HIBSAGO is contraindicated in patients:

with acute hepatic impairment or cirrhosis who have mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C).with a platelet count WARNINGS AND PRECAUTIONS

On-Treatment Hepatic Flares

Increases in ALT ≥3x ULN to 69x ULN were observed during treatment with HIBSAGO, most within the first 12 weeks. Isolated cases of ALT increases associated with an increase in total bilirubin resolved when treatment was permanently discontinued.

Thrombocytopenia

In addition to sudden and unpredictable thrombocytopenia, a gradual, dose-dependent decline in platelet count was observed in most patients that continued to worsen while on HIBSAGO. If a patient develops signs or symptoms of thrombocytopenia, pause HIBSAGO and obtain a platelet count as soon as possible. Instruct patients to report any symptoms of thrombocytopenia to their healthcare provider immediately. Consider the risks and benefits of treatment with HIBSAGO when treating patients who may be particularly susceptible to platelet count decreases.

Worsening Renal Function

Mean estimated glomerular filtration rate (eGFR) declined within 4 weeks of initiation and continued to decline during treatment. These changes were generally reversible after treatment discontinuation. Obtain eGFR and urine albumin-creatinine ratio (uACR) in all patients prior to initiation of treatment. Monitor eGFR frequently during and after treatment; treatment interruption or discontinuation may be necessary. Although no cases of glomerulonephritis were observed with HIBSAGO, glomerulonephritis has been observed with other antisense oligonucleotides; if suspected or confirmed, permanently discontinue HIBSAGO.

Inflammatory and Immune Effects

Influenza-like symptoms, laboratory test changes (e.g., decreases in complement factors C3 and C4), purpuric leg rashes, cutaneous leukocytoclastic vasculitis, dermatitis, pruritus/erythematous plaque, and polyarthralgia were observed. In addition, serious inflammatory and immune adverse reactions were reported, including immune thrombocytopenia, autoimmune hemolytic anemia, systemic inflammatory response syndrome, and a cryoglobulinemic flare.

Consider the risks and benefits of HIBSAGO in patients who may be susceptible to inflammatory and immune effects, including solid organ transplant recipients, patients with autoimmune hepatitis, patients with a history of or conditions associated with vasculitis, or extrahepatic disorders related to HBV immune-mediated effects. If signs and symptoms suggestive of vasculitis/immune-associated events occur, and no alternative cause is identified, permanently discontinue treatment with HIBSAGO.

Serious Adverse Reaction with Improper Administration

Improper HIBSAGO administration, including not rotating injection sites, has been associated with the serious adverse reaction of omental infarction in one participant. Ensure injection sites are rotated from one week to the next and that the two injections making up each dose are separated by at least 2 inches (5 cm). Never inject into areas where the skin is tender, bruised, red, or hard.

Post-Treatment Exacerbations of HBV Infection After NrtI Discontinuation

Severe acute exacerbations of HBV infection may occur after discontinuation of anti-HBV therapy. If NrtI therapy is discontinued after completing HIBSAGO treatment, frequent monitoring is recommended for at least one year to detect acute exacerbations of HBV infection and the possible need for resumption of HBV treatment.

Risk of human immunodeficiency virus-1 (HIV-1) Virologic Failure in Patients with HBV/HIV-1 Coinfection Who Discontinue NrtI Therapy

Patients who are taking NrtI for HIV-1 and HBV coinfection must not stop taking their NrtI unless an HIV healthcare provider has directed them to do so.

Risk of Hepatitis Flare in Patients with HBV/Hepatitis D Virus Coinfection

HIBSAGO is not recommended in patients with HDV coinfection due to the potential for an exacerbated risk of clinically significant ALT increases.

Unknown Effect on Preventing Transmission of HBV

There are no data on the effect of HIBSAGO in preventing transmission of HBV. Patients must be advised to use appropriate precautions to prevent transmission of HBV.

ADVERSE REACTIONS

The most common adverse reactions (≥10%), excluding laboratory abnormalities, reported with HIBSAGO included injection site reactions, pyrexia, fatigue, and headache.

Selected laboratory abnormalities worsened from baseline, including but not limited to, increases in ALT and total bilirubin, decreases in platelets and eGFR.

DRUG INTERACTIONS

Monitor patients for signs of bleeding and thrombocytopenia if HIBSAGO is taken concomitantly with anticoagulants, antiplatelets, or drugs that decrease platelet count.

Monitor patients for signs of worsening renal function during concomitant administration of HIBSAGO with drugs that may impair renal function.

Concomitant administration of HIBSAGO and peginterferon alfa-2a is not recommended due to the potential for an exacerbated risk of increased ALT, decreased platelet count, and immune-mediated effects.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation

There are insufficient data on HIBSAGO use in pregnancy or during breastfeeding. Consider the benefits of breastfeeding together with the mother’s clinical need for HIBSAGO.

Pediatric Use

HIBSAGO’s safety and effectiveness have not been established in patients under 18 years of age.

Renal Impairment

HIBSAGO can cause worsening renal function. No dosage adjustment is needed for mild renal impairment. Data are insufficient for moderate or severe renal impairment or end-stage renal disease (ESRD).

Please see full Prescribing Information, including Boxed Warning, for HIBSAGO.

Please see accompanying U.S. Prescribing Information here.

About B-Well 1 and B-Well 2

B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820) trials are global multi-center, randomized, double-blind, placebo-controlled trials conducted in 29 countries. They assessed the efficacy, safety, pharmacokinetic profile, and durability of functional cure in nucleos(t)ide analogue-treated adult participants with chronic hepatitis B and baseline surface antigen (HBsAg) ≤3000 IU/ml. The primary endpoint assessed the proportion of participants achieving functional cure in patients with baseline HBsAg ≤3000 IU/ml (assessed six months after all therapies were discontinued). A key ranked secondary endpoint evaluated functional cure in participants with baseline HBsAg ≤1000 IU/ml.

About Chronic Hepatitis B (CHB)

Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B occurs when the immune system is unable to clear the virus, resulting in long-lasting infection that affects more than 240 million people worldwide. The disease causes approximately 1.1 million deaths each year, and accounts for approximately 56% of liver cancer cases globally. Currently, many patients often require lifelong antiviral therapy for viral suppression, making functional cure a critical goal in disease management.

About Ionis Pharmaceuticals, Inc.

For more than three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has marketed medicines and a leading pipeline in neurology, cardiometabolic disease and select areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter), LinkedIn and Instagram.

Ionis Forward-looking Statements

This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of bepirovirsen, our commercial medicines, additional medicines in development and technologies and our expectations regarding development and regulatory milestones. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2025 and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our" and "us" all refer to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals® is a trademark of Ionis Pharmaceuticals, Inc. HIBSAGO is a trademark owned by the GSK group of companies.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261020102530/en/

MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT executives outlined the company’s strategy to build a liver-disease franchise around pemvidutide, a dual glucagon/GLP-1 agonist being developed for metabolic dysfunction-associated steatohepatitis, or MASH, alcohol use disorder, or AUD, and alcohol-related liver disease, or ALD.

Speaking at a Stifel session, Chief Executive Officer Jerome Durso said pemvidutide’s potential across several liver-related conditions was a primary reason he joined the company. He described the drug’s balanced dual mechanism, clinical tolerability and ability to keep patients on therapy as central elements of its development strategy.

Get Altimmune alerts:

How Altimmune Could Grab a Big Chunk of the GLP-1 Market“What we continue to see evidence of as the data emerges is a differentiated opportunity across MASH,” Durso said, adding that Phase 2 AUD data released in July created an additional opportunity for the company’s liver-focused portfolio.

MASH Program and PERFORMA Trial Altimmune is advancing pemvidutide in the Phase 3 PERFORMA trial in patients with F2 and F3 MASH. Chief Medical Officer Christophe Arbet-Engels said the trial includes placebo, 1.8-milligram and 2.4-milligram treatment arms. The company’s statistical powering is based on results observed with the 1.8-milligram dose in Phase 2, while the 2.4-milligram arm is intended to assess potential additional benefit.

This Small Cap Wealth Management Stock Could Provide Big ReturnsArbet-Engels said Phase 2 findings showed improvements in noninvasive tests and biological markers consistent with an anti-fibrotic effect, including continued improvement between 24 and 48 weeks. He noted that the company did not see an early fibrosis outcome at 24 weeks, which he said had been anticipated.

The Phase 3 trial will use a three-pathologist biopsy-reading process, supported by AIM-MASH Assist, an artificial intelligence-assisted tool intended to reduce variability in pathology assessments. Altimmune said it has trained pathologists and tested the approach ahead of the trial.

Key features of PERFORMA include a 52-week assessment period and simplified monthly titration. The company expects the longer study duration to better assess fibrosis improvement and said the titration approach could further reduce early gastrointestinal events and support treatment adherence.

Arbet-Engels characterized success as a positive trial demonstrating MASH resolution and fibrosis improvement, while also assessing effect size, patient subgroups, weight loss, discontinuations and adherence. The company will additionally evaluate the quality of weight loss, including measures related to lean mass preservation, using MRI-PDFF, blood biomarkers and functional testing.

Positioning Against Other Incretin-Based Therapies Altimmune executives emphasized what they view as pemvidutide’s differentiated molecular design. Arbet-Engels said pemvidutide has a 1:1 glucagon-to-GLP-1 ratio and strong affinity for both receptors. In contrast, he described survodutide as having a 7:1 glucagon-to-GLP-1 ratio and retatrutide as having substantially different receptor affinities.

The company also highlighted tolerability as a potential commercial and clinical differentiator. Arbet-Engels said pemvidutide’s EuPort domain is designed to slow delivery of the drug, reducing peak concentration and delaying the time to peak concentration. He said this profile supported favorable tolerability in Altimmune’s MASH trials.

Chief Commercial Officer Linda Richardson said the company believes pemvidutide could be relevant for patients who cannot tolerate GLP-1 therapy over time, who do not achieve desired efficacy with available options, or who may be at risk of sarcopenia. She also said the company sees potential opportunities both as a first-line treatment and as an add-on option in areas where other therapies may have limitations.

AUD and ALD Development Plans Durso said Altimmune’s Phase 2 RECLAIM results in AUD were encouraging, citing consistency across drinking-related endpoints, including two endpoints he said are approvable by the FDA. He also pointed to weight loss, safety and tolerability findings, as well as results from PEth testing, which is used to assess alcohol consumption.

Arbet-Engels added that exploratory FIB-4 findings provided indications of potential liver-related benefits, which the company plans to assess more rigorously in later-stage development.

Altimmune plans to hold an end-of-Phase-2 meeting with regulatory agencies to align on a Phase 3 AUD program. Durso said the company sees an opportunity to study a broad moderate-to-severe AUD population, including patients with active liver disease.

Arbet-Engels said AUD and ALD populations appear to overlap substantially, including through patterns of heavy drinking and obesity. While the company collected more extensive liver measurements in its ALD trial than in the Phase 2 AUD study, it expects future AUD studies to more comprehensively evaluate potential liver benefits.

Funding and Enrollment Chief Financial Officer Greg Weaver said Altimmune had $519 million as of June 30 and that the balance sheet was sufficient to fund the MASH trial through completion. For a potential Phase 3 AUD program, he said the company is focused on non-dilutive funding options, which could include strategic partnerships, clinical-trial financing or royalty-based structures.

The company also reported early enthusiasm from investigators for the PERFORMA study. Arbet-Engels said Altimmune moved from financing to dosing its first patient in about 90 days and cited the study’s weight-loss component, AI-assisted pathology process and ability for investigators to recycle screened patients between biopsy and noninvasive-test cohorts as attractive design elements.

About Altimmune (NASDAQ:ALT)Altimmune, Inc is a clinical-stage biotechnology company focused on developing treatments for obesity and liver diseases. The company's lead product candidate is pemvidutide, a dual GLP-1/glucagon receptor agonist being studied for chronic weight management and metabolic dysfunction-associated steatohepatitis (MASH), a form of liver disease associated with metabolic disorders.

Altimmune's research programs are designed to address diseases with significant unmet medical needs, including obesity-related complications and conditions involving liver inflammation and fibrosis.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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RINVOQ is now approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older who have responded inadequately to, or who are intolerant to, one or more DMARDs1Approval was based on the open-label Phase 1 SELECT-YOUTH study and data from adults with rheumatoid arthritis1,2A new oral solution of RINVOQ was approved for use in patients with pJIA1RINVOQ is currently approved in the European Union for 11 indications across various immune-mediated, inflammatory diseases1, /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib; 15 mg tablet and weight-based 1 mg/mL oral solution) for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients two years of age and older who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.1

"The European Commission's approval of RINVOQ for pJIA expands the treatment options available to pediatric patients and their families, offering the potential for remission, improvements in pain and physical function," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "RINVOQ's new indication continues to build on our differentiated immunology portfolio with breadth and depth across therapeutic areas and patient populations."

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood and is estimated to impact approximately 126,000 children in Europe.3 pJIA is a subtype of JIA and is characterized by inflammation in five or more joints – including the small joints of the hands and feet and large joints like the knees, hips and ankles – that persists for at least six weeks in children and adolescents.4,5 This disease can be painful and debilitating and, if left untreated, may lead to joint damage.3,6 Ongoing disease activity in pJIA is common, with persistent symptoms or flares affecting many patients into adulthood.6-8

Data Supporting the EC Approval
The EC approval of RINVOQ for pJIA is supported by the SELECT-YOUTH study and data from adult patients with rheumatoid arthritis. The SELECT-YOUTH study is a single-arm, open-label, global, Phase 1 study evaluating the pharmacokinetics, efficacy, safety and tolerability of RINVOQ in patients ages 2 to <18 years.1,2

RINVOQ demonstrated efficacy as early as week 12, with response rates improving through week 48, as shown below.1,2 The efficacy observed in children with pJIA was generally consistent with responses in adult patients with rheumatoid arthritis.1

SELECT-YOUTH Clinical Response1

Efficacy Measure

Week 12

RINVOQ*
(N=122)

Week 48

RINVOQ*
(N=122)

70% improvement of disease activity
(ACR pediatric 70 response), NRI1

66.4%‌

79.5%‌

Remission (JADAS27-CRP ≤1), NRI1

23.0%‌

43.4%‌

*All patients received RINVOQ 15 mg tablet or oral solution weight-based equivalent.

ACR=American College of Rheumatology; CRP=C-reactive protein; JADAS=Juvenile Arthritis Disease Activity Score; NRI=nonresponder imputation.

Functional ability, as measured by C-HAQ, improved, with a mean change from baseline of −0.46 (n=115) at week 12 and −0.64 (n=108) at week 48. Pain scores also improved, with a mean change from baseline of −26.2 (n=116) at week 12 and −30.8 (n=109) at week 48. C-HAQ and pain data are reported as observed.2

In the study, no new safety risks were identified.9 The rate of treatment-emergent adverse events (TEAEs) was 499.6 events per 100 patient-years (E/100 PY). The rate of serious adverse events was 10.2 E/100 PY. The rate of TEAEs that led to discontinuation of the study drug was 2.7 E/100 PY. No cases of major cardiovascular or thrombotic events, malignancies or deaths were reported during the study period.2 No negative impact on growth or development was observed.9

"The SELECT-YOUTH results underscore that clinical remission for children with pJIA is not a rare hope but a critical and achievable outcome that helps reduce the risk of permanent joint damage in some of our youngest, most vulnerable patients," said Prof. Dr. Gerd Horneff, head of the Department of General Pediatrics, Asklepios Clinic, Sankt Augustin, Germany. "The approval of RINVOQ in active pJIA provides a new oral systemic treatment option for patients suffering from this often-debilitating condition."

RINVOQ is also approved in the European Union for the treatment of adults and adolescents with atopic dermatitis, non-segmental vitiligo and alopecia areata and for adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and giant cell arteritis.1

About the SELECT-YOUTH Study
The SELECT-YOUTH (M15-340) study is a single-arm, open-label, global, Phase 1 study to evaluate the pharmacokinetics, efficacy, safety and tolerability of upadacitinib in patients with polyarticular course juvenile idiopathic arthritis (pcJIA), ages 2 to <18 years. This study consists of three parts: Part 1 consisted of a seven-day multiple-dose pharmacokinetic evaluation, after which patients in Parts 2 and 3 of the trial received a low dose of upadacitinib (equivalent to 15 mg) by using either a twice-daily oral solution or once-daily extended-release tablet based on their body weight and ability to swallow tablets. For more detailed information on this study, please visit clinicaltrials.gov (NCT03725007).

About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,10 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus and in pediatric studies for systemic juvenile idiopathic arthritis, atopic dermatitis, ulcerative colitis and Crohn's disease.

EU Indications and Important Safety Information about RINVOQ® (upadacitinib)1

Indications

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Polyarticular juvenile idiopathic arthritis

RINVOQ is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Giant cell arteritis

RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

Alopecia areata

RINVOQ is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Vitiligo

RINVOQ is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Crohn's disease

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Important Safety Information

Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.

Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.

Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.

Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.

Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.

Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.

Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active‑controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.

Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.

Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.

Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.

Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.

Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.

Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.

Medication residue in stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ tablets. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.

Giant cell arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.

Excipients with known effect
RINVOQ 1 mg/ml oral solution contains 0.3 mg sodium benzoate in each ml.

Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.

The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.

The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.

Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.

Overall, the safety profile observed in pediatric patients with pJIA treated with RINVOQ was consistent with the known safety profile of RINVOQ.

The safety profile of RINVOQ 15 mg and 30 mg observed in patients with alopecia areata was generally consistent with the known safety profile in patients with atopic dermatitis.

The safety profile of RINVOQ 15 mg observed in patients with vitiligo was generally consistent with the known safety profile in patients with atopic dermatitis. A higher incidence of hypercholesterolemia was observed in patients with vitiligo treated with RINVOQ 15 mg compared to placebo.

The most common serious adverse reactions were serious infections.

The safety profile of RINVOQ with long term treatment was generally similar to the safety profile during the placebo-controlled period across indications.

RINVOQ is available in 15 mg, 30 mg, and 45 mg prolonged-release tablets and 1 mg/ml oral solution. RINVOQ tablets and RINVOQ oral solution are not bioequivalent. Refer to the Summary of Product Characteristics for posology and method of administration.

This is not a complete summary of all safety information.

See RINVOQ full Summary of Product Characteristics (SmPC) at http://www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

RINVOQ. Summary of product characteristics. AbbVie; 2026.AbbVie. Data on file: ABVRRTI83601.Garner AJ, Saatchi R, Ward O, Hawley DP. Juvenile idiopathic arthritis: a review of novel diagnostic and monitoring technologies. Healthcare (Basel). 2021;9(12):1683. doi:10.3390/healthcare9121683Macaubas C, Nguyen K, Milojevic D, Park JL, Mellins ED. Oligoarticular and polyarticular JIA: epidemiology and pathogenesis. Nat Rev Rheumatol. 2009;5(11):616-626. doi:10.1038/nrrheum.2009.209Petty RE, Southwood TR, Manners P, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004;31(2):390-392.Hashkes PJ, Laxer RM. Medical treatment of juvenile idiopathic arthritis. JAMA. 2005;294(13):1671-1684. doi:10.1001/jama.294.13.1671Glerup M, Rypdal V, Arnstad ED, et al. Long-term outcomes in juvenile idiopathic arthritis: eighteen years of follow-up in the population-based Nordic juvenile idiopathic arthritis cohort. Arthritis Care Res (Hoboken). 2020;72(4):507-516. doi:10.1002/acr.23853Balay-Dustrude E, Weiss NS, Sutton A, Shenoi S. Predictors of disease activity in patients with juvenile idiopathic arthritis at 12 and 24 months after diagnosis. ACR Open Rheumatol. 2024;6(8):489-496. doi:10.1002/acr2.11701AbbVie. Data on file: ABVRRTI83825.Pipeline. AbbVie. 2026. Accessed July 8, 2026. https://www.abbvie.com/our-science/pipeline.html View original content:https://www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-rinvoq-upadacitinib-for-the-treatment-of-children-with-active-polyarticular-juvenile-idiopathic-arthritis-302885190.html

SOURCE AbbVie

Altimmune (NASDAQ:ALT – Get Free Report) and Denali Therapeutics (NASDAQ:DNLI – Get Free Report) are both healthcare companies, but which is the better business? We will contrast the two businesses based on the strength of their dividends, analyst recommendations, earnings, institutional ownership, risk, profitability and valuation.

Analyst Ratings This is a breakdown of current recommendations and price targets for Altimmune and Denali Therapeutics, as reported by MarketBeat.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Altimmune 1 1 7 0 2.67 Denali Therapeutics 1 2 13 0 2.75 Altimmune currently has a consensus target price of $14.33, indicating a potential upside of 343.76%. Denali Therapeutics has a consensus target price of $35.85, indicating a potential upside of 75.89%. Given Altimmune’s higher possible upside, equities research analysts clearly believe Altimmune is more favorable than Denali Therapeutics.

Valuation & Earnings This table compares Altimmune and Denali Therapeutics”s top-line revenue, earnings per share (EPS) and valuation. Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Altimmune $40,000.00 15,707.49 -$88.09 million ($0.78) -4.14 Denali Therapeutics $330.53 million 9.86 -$512.54 million ($2.84) -7.18 Altimmune has higher earnings, but lower revenue than Denali Therapeutics. Denali Therapeutics is trading at a lower price-to-earnings ratio than Altimmune, indicating that it is currently the more affordable of the two stocks.

Profitability This table compares Altimmune and Denali Therapeutics’ net margins, return on equity and return on assets.

Net Margins Return on Equity Return on Assets Altimmune -214,860.98% -31.41% -26.96% Denali Therapeutics N/A -55.27% -44.24% Volatility & Risk Altimmune has a beta of 0.18, indicating that its stock price is 82% less volatile than the S&P 500. Comparatively, Denali Therapeutics has a beta of 1.01, indicating that its stock price is 1% more volatile than the S&P 500.

Institutional & Insider Ownership 78.0% of Altimmune shares are owned by institutional investors. Comparatively, 92.9% of Denali Therapeutics shares are owned by institutional investors. 1.6% of Altimmune shares are owned by company insiders. Comparatively, 9.7% of Denali Therapeutics shares are owned by company insiders. Strong institutional ownership is an indication that large money managers, hedge funds and endowments believe a company will outperform the market over the long term.

About Altimmune (Get Free Report)

Altimmune, Inc., a clinical stage biopharmaceutical company, focuses on developing treatments for obesity and liver diseases. The company's lead product candidate, pemvidutide, a GLP-1/glucagon dual receptor agonist that is in Phase 2 trial for the treatment of obesity and metabolic dysfunction-associated steatohepatitis. It is also developing HepTcell, an immunotherapeutic product candidate, which is in Phase 2 clinical trial for patients chronically infected with the hepatitis B virus. The company was formerly known as Vaxin Inc. and changed its name to Altimmune, Inc. in September 2015. Altimmune, Inc. was founded in 1997 is headquartered in Gaithersburg, Maryland.

(Get Free Report)

Denali Therapeutics Inc., a biopharmaceutical company, develops a portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases and lysosomal storage diseases in the United States. The company’s transport vehicle (TV)-enabled programs include DNL310 ETV, an IDS enzyme replacement therapy program for MPS II; TAK-594/DNL593 which is in Phase 1/II for frontotemporal dementia-granulin; DNL126 program for MPS IIIA; and DNL622 for MPS I, as well as other preclinical programs that target amyloid beta and HER2. Its brain-penetrant small molecule programs comprise BIIB122/DNL151 LRRK2 inhibitor program for Parkinson’s disease; SAR443820/DNL788 RIPK1 inhibitor program for CNS disease; DNL343 eIF2B Activator program for amyotrophic lateral sclerosis; and SAR443122/DNL758 RIPK1 inhibitor program for peripheral inflammatory diseases. It also provides early stage program include TAK-594/DNL593 program for FTD-GRN; DNL126 program for MPS IIIA, a Sanfilippo Syndrome A; DNL622 for MPS I which is Hurler syndrome; Antibody Transport Vehicle Amyloid beta program; Oligonucleotide Transport Vehicle platform, a novel class of biotherapeutics to address the root cause of diseases through modulation of gene expression; and other TV-enabled discovery programs. The company has collaboration agreements with Biogen MA Inc. and Biogen International GmbH; Genzyme Corporation; Takeda Pharmaceutical Company Limited; F-star Gamma Limited, F-star Biotechnologische Forschungs-und Entwicklungsges m.b.H, and F-star Biotechnology Limited; and Genentech, Inc. The company was formerly known as SPR Pharma Inc. and changed its name to Denali Therapeutics Inc. in March 2015. Denali Therapeutics Inc. was incorporated in 2013 and is headquartered in South San Francisco, California.

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New York, NY, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Alpha AI Corporation ("Alpha AI"), developer of the Alpha Liquid Terminal ("ALTx"), today announced the relaunch of its platform as the ALT/X Compute Terminal, refocusing the product on pricing, power and capacity data for the global AI compute market. 

The relaunch follows the strategic investment made in Alpha Liquid Terminal by Alpha Compute Corp. (Nasdaq: ALP) announced December 16, 2025, and Alpha Compute's subsequent investment in Alpha AI Corporation, ALTx's parent company. 

The first public release is live now at altx.finance.

Why compute, and why now

Compute has emerged as the fundamental commodity of the artificial intelligence era, yet it remains one of the most opaque markets in existence. Rental rates for silicon fluctuate across various hardware generations, geographic regions, and commitment terms, operating without a standardized benchmark for pricing. Energy availability, now the primary bottleneck for infrastructure expansion, remains localized in its costs and regulatory framework. Consequently, purchasers are forced to negotiate without visibility, while operators and financial backers are committing to long-term deployments based on anecdotal and siloed information.

The ALT/X Compute Terminal applies the modular data-aggregation and AI-agent architecture originally built for digital asset markets to that problem.

What is in the first release

Compute Screener. Screen and compare GPU capacity across providers and regions, with filters spanning:

Accelerator type — NVIDIA H100, H200, B200 and B300-class hardware, and comparable siliconPricing structure — on-demand, spot, reserved and multi-year contracted rates, normalized to a per-GPU-hour basisRegion and jurisdiction — North America, Europe and other served marketsAvailability — advertised capacity, lead times and deployment status Power and energy layer. Industrial electricity rates, grid carbon mix, renewable sourcing, cooling and efficiency benchmarks, and interconnection conditions by region — surfaced alongside compute pricing so that all-in delivered cost, not headline rate, is the comparison.

Data center and capacity tracking. Facility-level coverage of announced, under-construction and live capacity, including operator, power envelope and energy profile.

ChatAnalyst for compute. ALTx's AI copilot, re-grounded on the compute dataset, answering natural-language questions about pricing spreads, regional cost differentials and capacity trends with citations back to underlying sources.

Roadmap

Planned phases include expanded provider and facility coverage, historical time series and index construction for benchmark GPU-hour pricing, forward and contract curves, an API for institutional users, and integration of confidential-compute and sovereign-AI capacity as a distinct tracked category.

The ALTX token utility framework described in the platform's published materials including pay-as-you-go data access, staking for premium data tiers, and rewards for verified data contribution is being adapted to the compute dataset. 

Relationship to Alpha Compute Corp.

Alpha Compute Corp. (Nasdaq: ALP) is an investor in both Alpha Liquid Terminal and its parent, Alpha AI Corporation. Alpha AI Corporation operates independently of Alpha Compute Corp. The ALT/X Compute Terminal is a vendor-neutral data platform and does not preference Alpha Compute capacity in its screener results.

About Alpha Liquid Terminal (ALT/X) and Alpha AI Corporation

Alpha Liquid Terminal is a modular research, analytics and execution platform developed by Alpha AI Corporation. Originally built for tokenized and digital asset markets with institutional-grade integrations and AI research agents, the platform is relaunching as the ALT/X Compute Terminal, to bring transparency to market data and an intelligence layer for GPU compute, power and AI infrastructure. Learn more at altx.finance.

About Alpha Compute Corp.

Alpha Compute Corp. (Nasdaq: ALP) is an AI infrastructure company specializing in GPU-as-a-service and AI Confidential Compute. Alpha Compute’s mission is to support clients, subsidiaries, and partners across critical sectors including: finance, defense, intelligence, and media with the essential framework for any organization requiring secure, confidential computing environments. For more information, please visit: https://www.alphacompute.ai/

The company is domiciled in the British Virgin Islands with offices in New York, Los Angeles, Miami, Amsterdam and Toronto. Alpha Compute is a founding partner of the Right2Compute Coalition; more information is available at www.right2compute.com 

Investor & Media Contact
Alpha Compute Corp.
[email protected]
www.alphacompute.ai 

 | Source: Altimmune, Inc

GAITHERSBURG, Md., Sept. 03, 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 a fireside chat at the Wells Fargo 21st Annual Healthcare Conference on Thursday, September 10, 2026, at 9:30 a.m. ET.

A webcast of the fireside chat 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 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.

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Investor Contact:
Luis Sanay, CFA
Vice President, Investor Relations
[email protected]

Media Contact:
Real Chemistry
[email protected]

ALT's stronger cash position supports pemvidutide's MASH, AUD and ALD programs, but long timelines, funding needs and competition remain risks.

Key Takeaways Altimmune's Q2 loss narrowed to 12 cents per share from 27 cents a year ago.Altimmune's cash, equivalents and short-term investments rose to $519M, supporting operations into 2029.Pemvidutide advanced in MASH, AUD and ALD, with the phase III MASH trials now underway.
Altimmune (ALT - Free Report) incurred a second-quarter 2026 loss of 12 cents per share, narrower than the Zacks Consensus Estimate of a loss of 15 cents. The company had recorded a loss of 27 cents per share in the year-ago quarter.

The company did not generate any revenues in the quarter, as it does not have a marketed drug in its portfolio.

ALT's Q2 Results in DetailResearch and development (R&D) expenses totaled $18.7 million in the reported quarter, up 8.2% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage metabolic dysfunction-associated steatohepatitis (MASH) study on Pemvidutide. R&D spending included $11.6 million in direct pemvidutide development costs.

General and administrative expenses were $7.6 million, up 33.1% year over year, primarily due to an increase in professional services and compensation expenses.

As of June 30, 2026, Altimmune had cash, cash equivalents and short-term investments of $519 million compared with $332 million as of March 31, 2026. Management expects its cash runway to support operations into 2029.

Year to date, shares of ALT have lost 18.9% compared with the industry’s 0.5% 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).

Based on positive data from the phase IIb IMPACT study announced in December 2025, Altimmune initiated the global phase III registrational PERFORMA study earlier this month. The study will evaluate the safety and efficacy of pemvidutide in MASH patients with moderate-to-severe liver fibrosis, with 52-week data expected in 2029.

Altimmune announced top-line data from the mid-stage RECLAIM study evaluating pemvidutide for the treatment of patients with AUD in July. The study met its primary endpoint by demonstrating a statistically significant reduction in heavy drinking days along with positive secondary endpoints. Pemvidutide showed a favorable safety profile and the company plans to discuss the next regulatory steps with the FDA and European authorities.

The company is developing the candidate in the phase II RESTORE study in patients with ALD. Patient enrollment was completed in July, with top line data expected in the second half of 2027.

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 Amneal Pharmaceuticals (AMRX - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy) and AC Immune (ACIU - Free Report) , which carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 40.2% year to date.

Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 128.5% 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%.

Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 16.6% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Altimmune, Inc. (ALT) Q2 2026 Earnings Call August 12, 2026 8:30 AM EDT

Company Participants

Luis Sanay
Jerome Durso - Chairman, CEO & President
Christophe Arbet-Engels - Chief Medical Officer
Linda Richardson - Chief Commercial Officer
Gregory Weaver - Chief Financial Officer

Conference Call Participants

Thomas Smith - Leerink Partners LLC, Research Division
Michael DiFiore - Evercore ISI Institutional Equities, Research Division
Eliana Merle - Barclays Bank PLC, Research Division
Srikripa Devarakonda - Truist Securities, Inc., Research Division
Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division
Catherine Okoukoni - Citizens JMP Securities, LLC, Research Division
Patrick Trucchio - H.C. Wainwright & Co, LLC, Research Division
William Wood - B. Riley Securities, Inc., Research Division
Tsan-Yu Hsieh - William Blair & Company L.L.C., Research Division

Presentation

Operator

Good morning, ladies and gentlemen. Welcome to the Altimmune Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded.

I'm going to introduce your host for today's conference call, Luis Sanay, Vice President of Investor Relations. Luis, you may begin.

Luis Sanay

Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's second quarter 2026 financial results and business update call. On today's call, you will hear from Jerry Durso, our Chairman and Chief Executive Officer; Dr. Christophe Arbet-Engels, Chief Medical Officer; Linda Richardson, Chief Commercial Officer; and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we'll open the line for questions. Our second quarter 2026 earnings release was issued this morning and can be found in the Investor Relations section of our website.

Before we begin, I would like to remind everyone that remarks made about future expectations, plans, and prospects constitute forward-looking statements for the purpose of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties

Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and investments as of June 30, 2026 Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md.

August 03, 2026 08:00 ET  | Source: Altimmune, Inc

Global registrational study designed to evaluate pemvidutide on fibrosis improvement, MASH resolution, and clinical outcomes 

Initiation marks advancement of Altimmune's lead program into late-stage development following positive IMPACT Phase 2b data

GAITHERSBURG, Md., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced that the company has begun enrolling patients in the PERFORMA Phase 3 trial evaluating the efficacy and safety of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH). Pemvidutide is an investigational balanced glucagon/GLP-1 dual receptor agonist also in development for the treatment of alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).

The PERFORMA trial is a global, Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and clinical outcomes of pemvidutide in MASH patients with moderate to advanced fibrosis. PERFORMA is Altimmune's registrational study for pemvidutide in MASH and will assess the effects of treatment on fibrosis improvement and MASH resolution as well as clinical outcomes. The trial follows positive findings from the IMPACT Phase 2b study and incorporates feedback from the U.S. Food and Drug Administration (FDA) and European regulatory agencies. The 52-week data readout from the trial is anticipated in 2029.

"The body of evidence, including favorable safety and tolerability, generated from the IMPACT Phase 2 trial supports the potential of pemvidutide as we advance into the PERFORMA Phase 3 trial," said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. "With the balanced one-to-one glucagon/GLP-1 receptor agonism providing direct effects on the liver, as well as metabolic benefits, pemvidutide may offer an important new treatment option for patients with MASH and serious liver diseases. We look forward to evaluating pemvidutide in a registrational setting."

“Initiating the PERFORMA Phase 3 trial is a key milestone for Altimmune and for the advancement of MASH treatment. We’re building momentum across our pemvidutide program in multiple indications, including the recently announced positive RECLAIM Phase 2 data in AUD. We remain focused on pemvidutide’s potential differentiation as we advance our franchise,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “In just three months, we moved from securing funding for PERFORMA to initiating the trial, reinforcing Altimmune’s commitment to execute with speed and efficiency.”

In the IMPACT Phase 2b study, pemvidutide demonstrated statistically significant MASH resolution rates, improvements in non-invasive measures of fibrosis and liver health, meaningful weight loss, and a generally favorable tolerability profile. The FDA granted Fast Track Designation and Breakthrough Therapy Designation to pemvidutide for the treatment of MASH.

MASH affects millions of individuals worldwide and is a leading cause of liver fibrosis, cirrhosis, liver transplantation, and liver-related mortality. More than 80% of patients with MASH are overweight or obese, highlighting the importance of therapies that address both liver disease and underlying metabolic dysfunction.

“MASH is a complex disease, and as clinicians, we need therapies that can effectively address both liver disease and the broader metabolic dysfunction that contributes to long-term health risks,” said Naim Alkhouri, MD, Chief Medical Officer, Summit Clinical Research and a principal investigator of the PERFORMA trial. “The initiation of PERFORMA is exciting because it will allow us to evaluate whether the broad improvements observed with pemvidutide in earlier studies can translate into meaningful outcomes for a larger population of patients with MASH.”

About the PERFORMA Phase 3 Study

The PERFORMA trial is a global, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study evaluating the efficacy and safety of pemvidutide in adults with metabolic dysfunction-associated steatohepatitis (MASH) and confirmed moderate to advanced liver fibrosis (F2–F3). The study is an event-driven study with an interim analysis to support the accelerated approval. The study includes two parallel cohorts; Cohort 1 will enroll approximately 990 patients and is designed to support the accelerated approval pathway based on a biopsy-assessed primary efficacy endpoint of MASH resolution and/or fibrosis improvement at 52 weeks. A second cohort will enroll approximately 800 patients with fibrosis as evidenced through non-invasive tests (NITs) to add to the safety dataset. The study incorporates a simple, 1- or 2- step monthly dose titration from 1.2mg to the 1.8mg or 2.4mg trial doses, respectively, to further improve tolerability. The PERFORMA trial will integrate the FDA-qualified AIM-MASH AI Assist tool to help standardize histological assessment of liver biopsy samples. Both cohorts will support the final regulatory approval which will be based on liver-related events at ~60 months.

About Pemvidutide

Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, 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, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward.

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 topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the Company announced topline results from the RECLAIM Phase 2 trial in AUD. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated in August 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.

Forward-Looking Statements

This press release has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the performance of our drug candidates in ongoing and future clinical trials including the RECLAIM trial, the ongoing RESTORE trial and PERFORMA trial, evaluating pemvidutide in patients with MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations and the prospects for regulatory approval, commercializing, market size, market potential, competitive landscape, or selling any product or drug candidates. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential”, “suggest” and similar expressions and their variants, as they relate to the Company 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 such as 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; patient baseline characteristics which may vary and impact the success of future trials; 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; whether the FDA will agree with the Company's proposed development and regulatory strategy for pemvidutide in AUD, including following any End-of-Phase 2 meeting; the risk that results from the RECLAIM trial may not be predictive of results in the RESTORE trial, the PERFORMA trial, or any other future or larger clinical trial; the Company's need for substantial additional capital to complete development of pemvidutide, which may not be available on acceptable terms or at all; competition from other companies developing treatments for MASH, AUD and ALD; and the success of future product advancements, including the success of current and 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 latest annual report on Form 10-K, quarterly report on Form 10-Q and our 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]

Altimmune, Inc. (ALT) Discusses Topline Results of RECLAIM Phase II Trial of Pemvidutide in Alcohol Use Disorder Transcript

Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial 

Important secondary endpoints were also met, including two-level reduction in WHO risk drinking levels and zero heavy drinking days, both of which are recognized by the FDA as registrational endpoints

A generally favorable tolerability profile was observed in the trial

Conference call to be held today at 8:00 am ET

GAITHERSBURG, Md., July 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced positive topline results from the RECLAIM Phase 2 trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days (HDD) versus placebo, with consistent positive results across important secondary endpoints, including the World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD and phosphatidyl ethanol (PEth) levels.  A generally favorable tolerability profile was observed in the trial. The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) based on the results of the trial.

“We are extremely encouraged by these compelling topline results, which showed a highly significant reduction in heavy drinking days and nearly two-thirds of patients treated with pemvidutide achieving a two-level reduction in their WHO-RDL, a clinically meaningful outcome for these patients,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer at Altimmune. “These data reflect pemvidutide’s strong and consistent efficacy across important measures of drinking behavior, together with a generally favorable tolerability profile in this difficult-to-treat disorder. Given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide’s promising potential differentiation.”

Efficacy Data

EndpointPlaceboPemvidutideTreatment EffectP-valueChange from baseline in HDD/Week at Week 24 (Primary Endpoint)-2.75 (LS mean)-4.20 (LS mean)-1.45 (LS mean difference)0.00142-level Reduction in WHO-RDL34.8% (16/46)64.4% (29/45)Odds Ratio 3.310.0049Zero HDD in Week 21 through Week 2417.4% (8/46)42.2% (19/45)Odds Ratio 3.840.0066Change from baseline in Percent of Days with Abstinence20.5% (LS mean)38.9% (LS mean)18.4% (LS mean difference)0.0075Change from baseline in Serum PEth at Week 2422.0 (LS mean)-153.4 (LS mean) -175.3 (LS mean difference)<0.0001      Key efficacy results included:

Statistically significant reduction in the primary endpoint of HDD per week versus placebo (p=0.0014)Statistically significant results on secondary endpoints, including two that are registrational endpoints Two-level reduction in WHO Risk Drinking Levels versus placebo (p=0.0049)Zero heavy drinking days versus placebo (p=0.0066) Statistically significant change in percent of days with abstinence versus placebo (p=0.0075)Statistically significant reduction in PEth levels versus placebo (p<0.0001)Statistically significant reduction in body weight, as measured by a placebo-adjusted difference in change from baseline of 9.1% at 24 weeks (p<0.0001), with no evidence of plateauing Safety and Tolerability Data

Adverse Event (AE)Placebo
(N=50)Pemvidutide 2.4mg
(N=50)Serious AEs1 (2%)2 (4%)Severe AEs3 (6%)6 (12%)Nausea12 (24%)22 (44%)Vomiting3 (6%)9 (18%)Diarrhea5 (10%)10 (20%)Constipation3 (6%)13 (26%)Treatment discontinuations11 (22%)10 (20%)Study drug-related AEs leading to treatment discontinuation0 (0%)5 (10%)*    *2 vomiting, 1 constipation, 1 fatigue, 1 exacerbation of hemorrhoids

Pemvidutide was generally well tolerated in this patient population with high unmet need.
The new, simple two-step titration for the 2.4 mg dose may improve gastrointestinal (GI) tolerability compared to prior pemvidutide titration schemes. The majority of adverse events were mild to moderate in severity. There was one serious adverse event (SAE) (hyponatremia) in the pemvidutide arm that was deemed possibly related to treatment drug by the principal investigator.

“As someone who has dedicated his career to understanding and treating alcohol use disorder, I recognize the significance of these findings, particularly given the current attention on the adverse health impact of heavy drinking. These results provide a consistent picture of treatment benefit on self-reported drinking outcomes, supported by objective PEth biomarker evidence,” said Henry Kranzler, M.D., Karl E. Rickels Professor of Psychiatry and Director, Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, and Principal Investigator of the RECLAIM trial. “These data underscore the potential for pemvidutide to address multiple dimensions of alcohol use disorder by supporting abstinence and reducing heavy drinking, findings that build on prior evidence of its activity in the liver.”

“These top-line data strengthen our confidence in pemvidutide's differentiation and its potential to benefit people living with MASH, AUD and ALD, who currently have limited treatment options,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “These results represent yet another important milestone for Altimmune as we continue to execute on our goal to bring pemvidutide to patients with serious liver diseases while creating value for shareholders.”

Based on these data, Altimmune plans to request an End-of-Phase 2 (EOP2) meeting with the FDA to discuss the path forward for pemvidutide in AUD. Results from the RECLAIM trial will be submitted for presentation at a forthcoming medical conference and for publication in a peer-reviewed journal.

Conference Call Information
Altimmune will host a conference call and webcast at 8:00 a.m ET today to discuss the RECLAIM topline data. The conference call will be webcast live on Altimmune’s Investor Relations (IR)  website. Participants who would like to join by phone may register here to receive the dial-in numbers and unique pin to access the call. Following the conclusion of the call, the webcast will be available for replay on the IR page of the company’s website.

About RECLAIM

RECLAIM (NCT06987513) is a Phase 2 trial evaluating the safety and efficacy of pemvidutide in Alcohol Use Disorder (AUD) patients with BMI >25 kg/m2, and is the first Phase 2 multicenter study evaluating a dual glucagon-GLP-1 agonist in AUD to report results. Approximately 100 patients were randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial was the change from baseline in the average number of heavy drinking days (HDD) per week, with secondary endpoints including the proportion of patients achieving a 2-level reduction in World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD, and absolute change from baseline in average levels of phosphatidylethanol (PEth), an objective serum biomarker of alcohol intake. The 2-level reduction in WHO risk drinking levels and zero HDD are recognized by the FDA as registrational endpoints.

About AUD

Alcohol use disorder (AUD) is a medical condition driven by an impaired ability to stop or control the harmful consumption of alcohol. AUD can also lead to serious health consequences, including liver cirrhosis, cardiovascular disease, and cancer. Additionally, many patients with AUD present with comorbidities including excess fat in the liver and obesity, further amplifying their risk for poor outcomes. The World Health Organization estimates that harmful alcohol consumption is the seventh leading cause of global death and disability, with alcohol accounting for 50% of all liver-related deaths.

Today, it is estimated that 28 million adults in the U.S. suffer from AUD. Patients with AUD are characterized as mild, moderate or severe according to the DSM-5 criteria with approximately 12 million having moderate or severe forms of the disease. Only three drugs for AUD have been approved by the FDA, but these agents have limited efficacy for AUD and its comorbidities and are used by less than 2% of patients. There is a substantial unmet need for new and more effective treatments that not only reduce alcohol cravings and heavy drinking days but also can address the numerous other risks of the disease.

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, and may play a role in pathways related to craving and reward.

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. In July 2026, the Company announced results from the RECLAIM Phase 2 trial in AUD. 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 third quarter 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 therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of MASH, AUD and ALD. For more information, please visit www.altimmune.com.

Forward-Looking Statements

This press release has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the performance of our drug candidates in ongoing and future clinical trials including the RECLAIM trial (topline results of which are described herein), the ongoing RESTORE trial and the planned PERFORMA trial, evaluating pemvidutide in patients with MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations and the prospects for regulatory approval, commercializing, market size, market potential, competitive landscape, or selling any product or drug candidates. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential”, “suggest” and similar expressions and their variants, as they relate to the Company 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 such as 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; patient baseline characteristics which may vary and impact the success of future trials; 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; whether the FDA will agree with the Company's proposed development and regulatory strategy for pemvidutide in AUD, including following any End-of-Phase 2 meeting; the risk that results from the RECLAIM trial may not be predictive of results in the RESTORE trial, the planned PERFORMA trial, or any other future or larger clinical trial; the Company's need for substantial additional capital to complete development of pemvidutide, which may not be available on acceptable terms or at all; competition from other companies developing treatments for MASH, AUD and ALD; and the success of future product advancements, including the success of current and 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 latest annual report on Form 10-K, quarterly report on Form 10-Q and our 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]

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SummaryAltimmune, Inc. is upgraded to Buy following successful fundraising, providing $535m to fund Phase 3 MASH trials through 2029.Pemvidutide's Phase 2b data showed statistically significant MASH resolution and fibrosis improvement, but competition from semaglutide, resmetirom, and others remains intense.ALT's near-term catalyst is the Phase 2 AUD data, with potential for partnership if results demonstrate differentiation in heavy drinking reduction and liver outcomes.ALT's investment case hinges on pemvidutide's ability to show clear superiority or unique benefits versus established GLP-1 therapies in upcoming trials.Looking for more investing ideas like this one? Get them exclusively at Haggerston BioHealth. Learn More » Tom Werner/DigitalVision via Getty Images

Investment Overview In my last note on Altimmune, Inc. (ALT), a biotech developing its lead candidate pemvidutide to treat patients with metabolic dysfunction-associated steatohepatitis (“MASH”), alcohol use disorder ("AUD"), or alcohol-associated liver disease ("ALD"), I downgraded its stock

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Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

The drug and biotech sector is in a recovery mode, after going through a difficult period between 2022 and 2024, backed by strong quarterly results, surging mergers and acquisitions (M&A) activity and pipeline and regulatory successes.
Innovation remains a key growth driver, with high-interest areas such as obesity treatments, next-gen oncology drugs, immunology, gene editing, cell therapies and RNA-based medicines drawing strong investor focus. However, the sector continues to face challenges, including pipeline setbacks, looming patent expirations, regulatory uncertainty, drug-pricing pressure and broader macro challenges.

Despite these headwinds, accelerating innovation, the expanding use of artificial intelligence in drug discovery and development, encouraging regulatory and clinical pipeline updates and the resurgence of M&A activity point to a constructive growth outlook for 2026.

Amid the improving backdrop, the Zacks Medical-Drugs industry is showing promising trends backed by a focus on innovation and positive pipeline/regulatory developments. In this scenario, Indivior Pharmaceuticals (INDV - Free Report) , Aurinia Pharmaceuticals (AUPH - Free Report) , Ironwood Pharmaceuticals (IRWD - Free Report) , Altimmune (ALT - Free Report) and Marker Therapeutics (MRKR - Free Report) may prove to be good additions to one’s portfolio.

Industry Description The Zacks Medical-Drugs industry comprises small and some medium-sized drug companies that make medicines. We have a separate industry outlook discussion on big drugmakers. Small drugmakers have a limited portfolio of marketed drugs or no commercial drugs at all. Some drugmakers are dependent on just one marketed drug or pipeline candidate. For such companies, upfront or milestone payments from collaboration partners — in most cases, their larger counterparts — are the main sources of revenues. These companies need ample free cash flow to fund their R&D costs.

Factors Shaping the Future of the Medical-Drugs Industry Pipeline Success: The success or failure of key pipeline candidates in clinical studies can significantly drive the stock price of industry players. Successful innovation and product line extensions in important therapeutic areas and strong clinical study results may act as important catalysts for the stocks.

Innovation is at its peak with key spaces like rare diseases, next-generation oncology treatments, obesity, immunology and neuroscience attracting investor attention.

Strong M&A Activity: These companies regularly seek external partners and collaborators for complementary strengths. A partnership deal with a popular drugmaker is a good sign about the potential of small pharma companies, especially when an equity investment is included in the deal. M&A deals are in full swing in the sector, signaling growth. This year has already seen multiple multi-billion-dollar deals. The trend is shifting more toward smaller and mid-size “bolt-on” strategic acquisitions rather than mega-mergers.

Investment in Technology for Innovation: For smaller companies, succeeding in a shifting global market and evolving healthcare landscape requires adopting innovative business models, investing in new technologies and increasing investments in personalized medicines. Over the past few years, scientific and technological advancements have made it possible to develop personalized therapies. Other than that, adoption and information exchange through the meaningful use of health IT, development of therapies that improve overall patient outcomes and investment in developing and emerging markets are some of the key priorities for drug companies. Artificial intelligence and machine learning techniques are being used for the rapid advancement of drug discovery and target identification processes.

Pipeline Setbacks: The smaller companies have their share of risk in the form of unstable cash flows. Also, the failure of key pipeline candidates in pivotal studies and regulatory and pipeline delays can be huge setbacks for these smaller companies and significantly hurt their share prices.

Zacks Industry Rank Indicates a Short-Term Gloomy Picture The group’s Zacks Industry Rank is basically the average of the Zacks Rank of all the member stocks.

The Zacks Medical-Drugs industry currently carries a Zacks Industry Rank #149, which places it in the bottom 40% of the 247 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.

Before we present you with a few top-ranked stocks to capitalize on the  prospects of the small and medium-sized drugmakers’ space, let’s take a look at the industry’s recent stock-market performance and the valuation picture.

Industry Versus S&P 500 and Sector The Zacks Medical-Drugs industry is a huge 133-stock group within the broader Medical sector. The industry has outperformed the S&P 500 but underperformed the Zacks Medical sector so far this year.

Stocks in this industry have collectively declined 0.5% so far this year against the Zacks Medical sector’s increase of 1.9%. The Zacks S&P 500 composite has declined 2% in the said time frame.

YTD Price Performance

Industry's Current Valuation Based on the trailing 12 months price-to-sales ratio (P/S TTM), which is a commonly used multiple for valuing these small drugmakers, the industry is currently trading at 2.26, compared with the S&P 500’s 5.94 and the Zacks Medical sector's 2.45.

Over the last five years, the industry has traded as high as 3.36, as low as 2.05 and at the median of 2.49, as the chart below shows. 

Trailing 12-Month Price-to-Sales (P/S) Ratio

5 Drug Stocks to Bet On Indivior Pharmaceuticals: North Chesterfield, VA-based Indivior’s commercial portfolio is anchored by its flagship product, Sublocade, a first-in-class long-acting injectable treatment for moderate-to-severe opioid use disorder, alongside Suboxone film and tablets, a daily buprenorphine/naloxone formulation for opioid dependence. Sublocade accounts for the majority of Indivior’s revenues.

Indivior remains a leader in opioid use disorder treatment, with Sublocade increasingly driving growth. The product continues to gain traction through record patient starts, growing prescriber adoption, and a leading share of the U.S. long-acting injectable market. The company is also benefiting from a major restructuring program, supporting strong earnings and EBITDA growth. Additionally, the large and persistent opioid addiction market provides a favorable long-term growth opportunity.

However, Indivior's internal pipeline has suffered setbacks. In 2026, the company decided not to advance INDV-6001 into phase III development and also halted the internal development of INDV-2000 for opioid use disorder after disappointing phase II data. 

The stock of Indivior has risen 15.5% so far this year. The consensus estimate for 2026 earnings has risen from $3.33 per share to $4.05 per share over the past 60 days. The company has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. .

Price and Consensus: INDV

Aurinia Pharmaceuticals: Canada-based Aurinia Pharmaceuticals makes medicines to treat autoimmune, kidney and rare diseases. It presently markets Lupkynis (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. The company recorded strong Lupkynis sales growth of 24% in the first quarter of 2026. Management expects total revenues to reach $315-$325 million in 2026, representing double-digit growth over 2025 levels. Lupkynis is emerging as a standard-of-care treatment for lupus nephritis.

Aurinia is also developing aritinercept, a potentially best-in-class dual inhibitor of BAFF and APRIL cytokines. It has the potential to treat a wide range of autoimmune diseases and is now in clinical development for three potential indications.

Aurinia Pharmaceuticals has a Zacks Rank #2 (Buy). The consensus estimate for 2026 earnings has been stable at 86 cents per share over the past 60 days. The stock has risen 16.7% so far this year.

Price and Consensus: AUPH

Altimmune: Gaithersburg, MD-based Altimmune is a late clinical-stage biotech focused on making therapies for liver diseases. Altimmune’s lead pipeline candidate, pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, has a differentiated mechanism of action and “pipeline in a product” potential for treating liver diseases. It is being developed to treat serious liver diseases like metabolic dysfunction-associated steatohepatitis (“MASH”), alcohol use disorder (“AUD”) and alcohol-associated liver disease (“ALD”), which have a significant unmet need. A phase III study for MASH patients with moderate-to-severe liver fibrosis is expected to start in 2026. For the AUD and ALD indications, phase II studies are ongoing. Multiple catalysts are expected in 2026, including phase III initiation for MASH and phase II top-line data for AUD. Its promising pipeline makes it an attractive licensing or takeover target.

The stock of Altimmune has declined 18.3% so far this year. The consensus estimate for 2026 loss has narrowed from $1.00 per share to 69 cents per share over the past 60 days. The company has a Zacks Rank #2.

Price and Consensus: ALT

Ironwood Pharmaceuticals: Cambridge, MA-based Ironwood Pharmaceuticals’ primary asset is Linzess, a leading treatment for irritable bowel syndrome with constipation and chronic idiopathic constipation. The drug continues to demonstrate healthy prescription demand growth and has treated millions of patients since launch. Management expects U.S. Linzess net sales to reach $1.125-$1.175 billion in 2026

Ironwood is also regularly getting approvals to expand Linzess' label, which is also supporting sales growth. Linzess is also well protected by patents and is not expected to face generic competition before March 2029.

Apraglutide, Ironwood's lead pipeline candidate for treating short bowel syndrome with intestinal failure (SBS-IF), represents a potentially game-changing growth opportunity for the company. Ironwood recently reached an agreement with the FDA on the design of a confirmatory phase III study required to support regulatory approval of apraglutide in SBS-IF. Management believes that, if successfully developed and approved, apraglutide has the potential to achieve blockbuster status.

The stock of Ironwood has risen 16% so far this year. The consensus estimate for 2026 earnings has risen from 88 cents per share to $1.04 per share over the past 60 days. The company has a Zacks Rank #2.

Price and Consensus: IRWD

Marker Therapeutics: This Houston, TX-based cancer biotech is making next-generation T cell therapies for hematological malignancies and solid tumors, leveraging its multi-antigen recognizing (MAR) T cell platform. Marker is rapidly progressing a phase I APOLLO study on lead candidate, MT-601, in patients with relapsed or refractory B-cell lymphoma. Updated data from the study reported last August demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non-Hodgkin lymphoma, including durable complete responses, with a favorable safety profile across evaluated doses. A data update from the APOLLO study is expected in the second quarter of 2026. Clinical studies on MT-601 in pancreatic cancer are also expected to begin in the second quarter of 2026.

Marker is also conducting a phase I study on its off-the-shelf candidate, MT-401 and entered into a strategic manufacturing collaboration with Cellipont to scale up production of MT-601. The stock of Marker Therapeutics has declined 12.1% so far this year. The consensus estimate for 2026 loss per share has narrowed from $1.19 to $1.17 over the past 60 days. The company has a Zacks Rank #2. 

Price and Consensus: MRKR

Ticker Change Reflects the Company's Continued Evolution Across Payments, Tokenization and AI-Driven Infrastructure

LAS VEGAS, NV / ACCESS Newswire / April 29, 2026 / AI Financial Corporation (NASDAQ:AIFC)(FRA:5AR1) ("AiFi" or the "Company"), formerly ALT5 Sigma Corporation (NASDAQ:ALTS), a fintech company providing blockchain-powered payment, trading, and settlement infrastructure for digital assets, today announced that its common stock will begin trading under its new corporate name and Nasdaq ticker symbol, AIFC, effective at the open of market trading today, Wednesday, April 29, 2026.

The Company's common stock ceased trading under the ticker symbol ALTS following after-market trading on Tuesday, April 28, 2026, and now trades under the new ticker symbol AIFC. The Company will continue to trade on The Nasdaq Stock Market without interruption, and the CUSIP number associated with its common stock will remain unchanged. The Company's Frankfurt ticker symbol, 5AR1, will remain unchanged. No action is required by existing stockholders.

The name change reflects the Company's continued evolution toward a broader financial platform that will be designed to support increasingly programmable and automated financial activity.

Tony Isaac, President and Chief Executive Officer, stated, "Today marks an important milestone as we begin trading as AI Financial Corporation under our new Nasdaq ticker symbol, AIFC. Our focus has been on building a strong operating foundation across payment processing, trading, and settlement. AiFi represents the next step in that evolution, positioning the Company to evaluate opportunities at the intersection of payments, tokenization, and AI."

About AI Financial Corporation (AiFi)

AI Financial Corporation (NASDAQ:AIFC) is a fintech company providing global payments, trading, and settlement infrastructure for digital assets, including solutions that support crypto-to-fiat and fiat-to-crypto transactions. Built on infrastructure that has processed more than $8 billion in cumulative transaction volume since inception, AiFi serves institutional and enterprise clients across the evolving digital financial ecosystem. The Company is focused on expanding its platform capabilities to support emerging forms of financial activity, including tokenization, software-driven financial systems, and AI-enabled applications and autonomous transaction infrastructure.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements generally relate to future events or the Company's future financial or operating performance and may include statements regarding the Company's strategic direction, the expected benefits of the corporate name and ticker symbol change, and potential future initiatives.

In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "potential," "continue," or the negative of these terms or other comparable terminology. These statements are based on management's current expectations, assumptions, and beliefs, and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described in the forward-looking statements.

These risks and uncertainties include, but are not limited to: the availability of capital to support future development; the Company's ability to develop, acquire, or integrate new technologies; the Company's ability to execute on its strategy under its new corporate identity and ticker symbol; changes in market conditions; regulatory developments affecting the Company's business; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent filings.

Forward-looking statements relating to potential future platform capabilities, including those associated with tokenized assets and on-chain financial infrastructure, are subject to ongoing evaluation. The Company does not currently offer certain of these capabilities within its commercial platform, and there can be no assurance that such capabilities will be successfully developed or implemented.

Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Investor Relations
Gateway Group, Inc.
Phone: +1 (949) 574-3860
Email: [email protected]

SOURCE: AI Financial Corporation

May 13, 2026 07:15 ET  | Source: Altimmune, Inc

Abstract presenting 48-week IMPACT Phase 2b efficacy and safety data selected for inclusion in “Best of EASL 2026” by EASL

Oral presentation will highlight further the 48-week IMPACT efficacy and safety data

Late-breaker abstract featuring new digital pathology analysis of liver fibrosis regression from IMPACT 24-week data

GAITHERSBURG, Md., May 13, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that analyses of data from its IMPACT Phase 2b clinical trial in metabolic dysfunction-associated steatohepatitis (MASH) will be presented at the European Association for the Study of the Liver (EASL) Congress 2026, taking place May 27-30 in Barcelona, Spain.

Data will be featured in both an oral presentation and several poster sessions, including a late-breaking poster presentation. The company also announced that its abstract on 48-week results has been selected by EASL as Best of EASL 2026 in their summary deck for its noteworthy contribution to the scientific program of the EASL congress.

The oral presentation will showcase 48-week efficacy and safety results from the IMPACT Phase 2 trial, while additional poster presentations will focus on new 24-week findings, including digital pathology analysis of fibrosis regression, a response analysis to multiple non-invasive tests (NITs) of liver inflammation and fibrosis and data on cardiovascular measures.

Oral Presentation

Abstract Title: Week 48 Top-Line Results from the Phase 2b, Multicenter, Randomized, Placebo-Controlled IMPACT Trial of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis
Session: MASLD: Clinical and Therapeutic Aspects I (OS-016)
Date/Time: Thursday, May 28, 17:00 CEST
Presenter: Dr. Mazen Noureddin, Professor of Medicine, Houston Methodist Hospital; Chief Scientific Officer and Co-Chairman, Summit Clinical Research

Poster Presentations

Late-Breaking Poster
Abstract Title: Pemvidutide Treatment Led to Fibrosis Regression After 24 Weeks in Patients with MASH: Quantitative Digital Pathology Analysis from the Phase 2b IMPACT Trial
Session: Late Breaker Posters (LBP-036)
Date/Time: Wednesday, May 27, 08:30 CEST
Presenter: Dr. Shaheen Tomah, Director, Clinical Development, Altimmune

Poster Presentation
Abstract Title: Concurrent Responses in Multiple Non-Invasive Tests for Hepatic Inflammation and Fibrosis Following Pemvidutide Treatment: 24-Week Responder Analyses from the Phase 2b IMPACT Trial
Session: MASLD: Therapy (TOP-176)
Date/Time: Friday, May 29, 08:30-17:00 CEST
Presenter: Dr. Scot Roberts, Chief Scientific Officer, Altimmune

Poster Presentation
Abstract Title: Effect of Pemvidutide on Cardiovascular Risk Factors in Patients with MASH: 48-Week Results from the Phase 2b IMPACT Trial
Session: MASLD: Therapy (FRI-201)
Date/Time: Friday, May 29, 08:30-17:00 CEST
Presenter: Dr. Shaheen Tomah, Director, Clinical Development, Altimmune

A copy of the oral presentation and posters will be available in the Events section of the Altimmune website.

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 Phase 2 RECLAIM trial in AUD and RESTORE trial in ALD were initiated in May 2025 and July 2025, respectively, and are currently ongoing.

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 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.

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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 related to the completed IMPACT trial, or the ongoing RECLAIM and RESTORE trials, the timing of key milestones for the Company’s clinical programs, 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, 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]

MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT said it has strengthened its balance sheet and is preparing to begin a global Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis, or MASH, in the second half of 2026, as the company reported first-quarter financial results and provided updates across its liver disease pipeline.

President and Chief Executive Officer Jerome Durso said the company has made progress since the start of the year in building its team, advancing pemvidutide and securing additional capital. In April, Altimmune completed an oversubscribed public offering that generated $225 million in gross proceeds. Together with existing funds, the company had approximately $535 million in cash as of April 30, which Durso said is expected to fund operations through the Phase 3 MASH 52-week data readout expected in 2029.

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How Altimmune Could Grab a Big Chunk of the GLP-1 Market“We’re entering a new phase for the company with the right team in place and a very strong balance sheet,” Durso said. “We’re now focused on execution and believe we’re well-positioned to successfully execute our strategy.”

Phase 3 MASH Trial Set to Begin in Second Half Altimmune’s lead program is pemvidutide, a balanced 1-to-1 glucagon and GLP-1 dual agonist being developed for MASH and other liver conditions. Durso said the company has finalized the protocol for its global Phase 3 MASH trial, called PERFORMA, and submitted it to the U.S. Food and Drug Administration as part of the standard process. He also said Altimmune completed the scientific advice process in Europe and that the final protocol is aligned with feedback from the European Medicines Agency.

This Small Cap Wealth Management Stock Could Provide Big ReturnsChief Medical Officer Dr. Christophe Arbet-Engels said startup activities for PERFORMA are progressing as planned, including work with a contract research organization, global vendors, laboratories and clinical supply chains. He said the company expects to begin screening and enrolling patients in the second half of the year.

Arbet-Engels said the company has alignment with both the FDA and EMA on the Phase 3 trial design. He described PERFORMA as an event-driven study, with a 52-week biopsy-based interim analysis intended to support accelerated approval. The company expects the 52-week data readout in 2029.

The Phase 3 program will evaluate 1.8 mg and 2.4 mg doses of pemvidutide. Arbet-Engels said the 1.8 mg dose is the company’s “anchor dose” based on Phase 2 data, while the 2.4 mg dose is being included because it showed additional weight loss in a prior obesity study and may offer added liver efficacy. He said the study is powered conservatively using the effect size observed with the 1.8 mg dose.

Company Highlights Tolerability and Weight Loss Profile Durso and other executives emphasized what they described as pemvidutide’s potentially differentiated profile in MASH, including tolerability, efficacy and “quality weight loss.” Durso said recent market research conducted by the company indicated that prescribing decisions in MASH may be influenced by a favorable tolerability profile that does not sacrifice efficacy, along with quality weight loss.

Chief Commercial Officer Linda M. Richardson said pemvidutide’s potential target product profile includes early metabolic benefits, improvements in inflammation and fibrosis, weight loss that may help preserve lean muscle mass, and a simple titration schedule. She said that in the Phase 2 IMPACT trial, both the 1.2 mg and 1.8 mg doses were efficacious and well-tolerated, with fewer adverse event-related discontinuations in the pemvidutide arms than in the placebo group.

Richardson contrasted pemvidutide’s planned titration approach with some GLP-1-based therapies, which she said have been associated with gastrointestinal side effects and discontinuations in clinical trials and real-world use. She said the Phase 3 design starts at an active 1.2 mg dose and escalates to either 1.8 mg or 2.4 mg after one or two four-week titration steps.

Richardson also said the company plans to evaluate lean muscle mass preservation in the Phase 3 MASH program, noting that MASH patients are often diagnosed in an age range where muscle loss becomes more clinically relevant.

Additional Pemvidutide Data Expected in 2026 Arbet-Engels said the 48-week results from the Phase 2 IMPACT trial will be presented orally by Dr. Mazen Noureddin at the EASL conference in Barcelona later this month. He said the abstract was selected as a “best of EASL” abstract. Altimmune also plans to present three posters at the conference covering cardiovascular risk factors, weight loss, noninvasive tests and qFibrosis.

During the question-and-answer session, Arbet-Engels said the EASL presentations will include additional qFibrosis evidence related to early anti-fibrotic effects at 24 weeks, as well as analyses related to weight loss, lipids and cardiovascular risk. He said qFibrosis is distinct from the AIM-MASH AI Assist tool that Altimmune plans to incorporate into the Phase 3 biopsy read process.

Arbet-Engels said Altimmune expects top-line data next quarter from the Phase 2 RECLAIM trial of pemvidutide in alcohol use disorder, or AUD. The study is evaluating the 2.4 mg dose in 100 subjects with moderate to severe AUD over 24 weeks. The primary endpoint is change from baseline in heavy drinking days, defined as five or more drinks for men and four or more drinks for women in a 24-hour period.

Key secondary endpoints include zero heavy drinking days, a two-level reduction in the World Health Organization risk drinking level, changes in alcohol consumption, and changes in body weight and BMI. The company is also measuring phosphatidylethanol, or PEth, as an exploratory blood-based biomarker of alcohol consumption.

Durso said that after the AUD data readout, Altimmune will assess the full data set and hold regulatory discussions before deciding whether to advance the indication. If the company sees value in moving forward, he said Altimmune would prefer to explore non-dilutive funding options for the program.

Altimmune is also studying pemvidutide in alcohol-associated liver disease, or ALD. The company now expects to complete enrollment in the RESTORE trial in the third quarter of 2026.

First-Quarter Financial Results Chief Financial Officer Greg Weaver said Altimmune reported $332 million in cash as of March 31 and $535 million on a pro forma basis as of April 30, after the public offering. He said this cash position is expected to provide operating runway through the Phase 3 MASH 52-week data readout.

Research and development expense: $16.2 million in the first quarter of 2026, compared with $15.8 million in the prior-year period. General and administrative expense: $8.1 million, compared with $6.0 million in the first quarter of 2025. Net loss: $22.6 million, or $0.18 per share, compared with a net loss of $19.6 million, or $0.26 per share, in the year-earlier quarter. Weaver said the increase in research and development spending was driven primarily by ongoing AUD and ALD trials, as well as startup costs for the Phase 3 MASH trial, partially offset by lower expenses tied to completion of the Phase 2 IMPACT trial. He said the increase in general and administrative expense was primarily due to severance costs and professional fees.

In closing remarks, Durso said Altimmune has made “significant progress” as it evolves into a late-stage company and remains focused on advancing pemvidutide and creating long-term shareholder value.

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].

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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%.

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/

May 27, 2026 08:30 ET  | Source: Altimmune, Inc

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 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.

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Investor Contact:
Luis Sanay, CFA
Vice President, Investor Relations
[email protected]

Media Contact:
Real Chemistry
[email protected]

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.

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.

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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].

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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.