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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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, Aurinia Pharmaceuticals, Ironwood Pharmaceuticals, Altimmune and Marker Therapeutics 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 IndustryPipeline 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 PictureThe 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 SectorThe 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.
Industry's Current ValuationBased 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.
5 Drug Stocks to Bet OnIndivior 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.
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.
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.
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.
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.
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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.
A month has gone by since the last earnings report for Altimmune, Inc. (ALT - Free Report) . Shares have lost about 11.3% in that time frame, underperforming the S&P 500.
Will the recent negative trend continue leading up to its next earnings release, or is Altimmune due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Altimmune, Inc. before we dive into how investors and analysts have reacted as of late.
Altimmune’s Q1 Loss Narrower Than Expected, Revenues Nil
Altimmune 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 Detail
Research 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 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.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a upward trend in fresh estimates.
The consensus estimate has shifted 30.21% due to these changes.
VGM ScoresCurrently, Altimmune has a subpar Growth Score of D, however its Momentum Score is doing a lot better with an A. However, the stock has a grade of F on the value side, putting it in the bottom 20% quintile for value investors.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been trending upward for the stock, and the magnitude of these revisions looks promising. It comes with little surprise Altimmune has a Zacks Rank #2 (Buy). We expect an above average return from the stock in the next few months.
Performance of an Industry PlayerAltimmune belongs to the Zacks Medical - Drugs industry. Another stock from the same industry, Esperion Therapeutics (ESPR - Free Report) , has gained 1% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026.
Esperion Therapeutics reported revenues of $80.1 million in the last reported quarter, representing a year-over-year change of +23.2%. EPS of -$0.10 for the same period compares with -$0.21 a year ago.
For the current quarter, Esperion Therapeutics is expected to post a loss of $0.02 per share, indicating no change from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days.
The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Esperion Therapeutics. Also, the stock has a VGM Score of D.
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.
GAITHERSBURG, Md., May 06, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that it will report its first quarter 2026 financial results on Wednesday, May 13, 2026.
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]
Initiation of PERFORMA Phase 3 MASH trial planned for second half 2026 $535 million in cash, cash equivalents and short-term investments as of April 30, 2026 Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md.
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%.
Key Takeaways Altimmune plans to launch a global phase III MASH study for pemvidutide in 2H 2026.ALT reported phase IIb data showing MASH resolution and fibrosis improvement through 48 weeks.Altimmune expects top-line AUD study data in Q3 2026 and is advancing a phase II ALD study. Altimmune (ALT - Free Report) , a late clinical-stage biotech, is focused on developing therapies for liver diseases. Its lead pipeline candidate, pemvidutide, is a balanced 1:1 glucagon/GLP-1 dual receptor agonist and has a differentiated mechanism of action with a “pipeline in a product” potential for the treatment of liver diseases. Altimmune is positioning itself as a differentiated player with the potential to compete in large commercial indications such as metabolic dysfunction-associated steatohepatitis ("MASH"), alcohol use disorder ("AUD") and alcohol-associated liver disease ("ALD").
Year to date, shares of Altimmune have lost 18.9% compared with the industry’s 6.5% decline.
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Strong Momentum in the Multi-Billion-Dollar MASH MarketAn important catalyst supporting investor enthusiasm is Altimmune’s expanding opportunity in the MASH market. The disease represents a multi-billion-dollar commercial opportunity with limited approved treatment options. The recent data from the phase IIb IMPACT study evaluating pemvidutide in MASH patients demonstrated statistically significant MASH resolution without worsening of fibrosis at 24 weeks, sustained through 48 weeks. It also showed clear signs of reducing liver scarring by 48 weeks. Key markers of liver damage and inflammation continued to improve over time, showing steady progress with the added benefit of weight loss.
The candidate’s relatively simple dosing profile may also support better patient adherence compared with more complex injectable regimens.
Altimmune recently announced alignment with the FDA on key parameters for a late-stage MASH program and plans to initiate a global phase III registrational PERFORMA study in the second half of 2026. The study will evaluate pemvidutide in MASH patients with moderate-to-severe fibrosis, with 52-week data expected in 2029.
Pemvidutide’s Expansion Beyond MASHBeyond MASH, Altimmune is also evaluating pemvidutide in separate mid-stage studies for alcohol-related diseases like AUD and ALD. Top-line data from the mid-stage RECLAIM study evaluating pemvidutide for the treatment of patients with AUD is expected in the third quarter of 2026. Enrollment was completed ahead of schedule in November 2025.
Altimmune is also developing the candidate in the phase II RESTORE study in patients with ALD. Patient enrollment is expected to be completed by the third quarter of 2026.
The candidate holds Fast Track designations for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH.
ALT's Zacks Rank & EstimatesAltimmune currently carries a Zacks Rank #2 (Buy). Over the past 30 days, estimates for ALT’s 2026 and 2027 loss per share have narrowed from $1.00 to 69 cents and from $1.00 to 73 cents, respectively.
Other Stocks to ConsiderSome other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR's shares have lost 13.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV's shares have risen 4.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA's shares have gained 79.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
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.
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Concurrent improvement across key non-invasive tests underscores convergence of
pemvidutide effects on MASH disease activity and fibrosis
AI-based digital pathology analyses further demonstrate antifibrotic effects of pemvidutide
at 24 weeks
GAITHERSBURG, Md., May 27, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that new analyses of data from the IMPACT Phase 2b trial demonstrated that treatment with pemvidutide, an investigational, balanced 1:1 glucagon/GLP-1 dual receptor agonist, is associated with concurrent improvements across multiple non-invasive tests (NITs) of metabolic dysfunction-associated steatohepatitis (MASH) activity and fibrosis. These new data reinforce a consistent and clinically meaningful treatment effect observed at just 24 weeks. These findings are based on analyses of overlapping markers of liver fat, inflammation and fibrosis. The analyses are further supported by separate AI-based digital pathology data showing significant improvements in fibrosis stage by HistoIndex qFibrosis® at 24 weeks, providing potent evidence of the antifibrotic potential of pemvidutide.
The data are being presented today and Friday in poster sessions, including a late-breaking poster presentation, at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain.
“The ability of pemvidutide to demonstrate concurrent improvements across multiple non-invasive markers – and to see those findings supported by histologic measures of fibrosis – provides a more comprehensive and clinically meaningful view of its potential beneficial effect in patients with MASH,” said Naim Alkhouri, MD, Chief Medical Officer, Summit Clinical Research. “These results point to the potential ability of pemvidutide to address multiple dimensions of disease biology, including fibrosis, and support its potential to target key drivers of MASH.”
Highlights of the data presented at EASL 2026 include:
Pemvidutide treatment resulted in significant increases in the percentage of patients achieving concurrent improvements across key NITs compared with placebo at 24 weeks – including in liver fat content (LFC), alanine aminotransferase (ALT), liver stiffness measurement (LSM) and enhanced liver fibrosis (ELF).37.8% of patients taking pemvidutide 1.2 mg and 22.7% of patients taking pemvidutide 1.8 mg achieved concurrent >0.5 ELF reduction plus >30% LSM reduction compared with 8.3% of patients taking placebo (p=0.0002 and p=0.02, respectively). These overlapping NIT responses provide a more stringent and clinically meaningful assessment of treatment effect and also evidence of improvement across multiple dimensions of disease biology. The findings are further supported by AI-based digital pathology analyses using qFibrosis, which utilizes advanced Second Harmonic Generation (SHG)/Two-Photon Excitation Fluorescence (TPEF) imaging to quantify fibrosis across the entire biopsy sample, enabling detection of continuous and intra-stage changes in fibrosis. Those results showed:
Pemvidutide treatment led to significant reductions in continuous fibrosis values versus placebo.68.6% of patients taking pemvidutide 1.2 mg and 54.5% of patients taking pemvidutide 1.8 mg achieved ≥1 stage qFibrosis regression compared with 29.6% of patients taking placebo (p<0.001 and p=0.002, respectively) after 24 weeks of treatment. “The consistency of these findings across non-invasive markers and advanced imaging approaches reflects the potential early impact of pemvidutide in addressing MASH,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “These multiple consistent analyses strengthen our confidence in pemvidutide and its potential to address significant unmet needs among patients living with MASH. In addition, 48-week data demonstrating a clear dose effect at the 1.8 mg dose further reinforces our confidence in the robustness and durability of the clinical response. Based on these promising Phase 2b clinical data, we are excited to begin patient enrollment in our PERFORMA Phase 3 trial of pemvidutide in patients with MASH in the second half of this year.”
About the IMPACT Phase 2b Study
The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks.
About Pemvidutide
Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss.
The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The RECLAIM Phase 2 trial in AUD completed enrollment in November 2025 and topline data are expected in third quarter 2026. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the second half of 2026.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.
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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 the ongoing RECLAIM and RESTORE trials and planned PERFORMA Phase 3 trial, the timing of key milestones for the Company’s clinical programs, including the anticipated launch of the PERFORMA Phase 3 trial in MASH, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.
Investor Contact:
Luis Sanay, CFA
Vice President, Investor Relations [email protected]
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]
“Best of EASL” oral presentation highlights meaningful reductions in triglycerides, cholesterol, and blood pressure, along with improvements in key metabolic risk factors
PERFORMA Phase 3 trial to further evaluate the broad metabolic and liver-related effects of pemvidutide
GAITHERSBURG, Md., May 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that new 48-week data from the IMPACT Phase 2b trial show that pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, significantly reduced elevated lipids while improving multiple cardiometabolic risk factors in patients with metabolic dysfunction-associated steatohepatitis (MASH). The findings demonstrated reductions in triglycerides and total cholesterol, along with improvements in weight, waist circumference and blood pressure, highlighting the broad impact of pemvidutide on key drivers of MASH. The data were presented for the first time at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain.
“MASH therapies that can address both liver disease and its underlying metabolic drivers are urgently needed to improve outcomes for patients,” said Mazen Noureddin, M.D., IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital, and Chief Scientific Officer and Co-Chairman of Summit Clinical Research. “These 48-week IMPACT trial findings are particularly compelling because they demonstrate meaningful reductions in liver fat and fibrosis biomarkers, and in lipids elevated at baseline, alongside improvements in weight and other cardiometabolic risk factors. In patients with MASH, where cardiovascular disease remains a leading cause of mortality, seeing this type of broad metabolic impact is highly relevant to overall patient outcomes."
Highlights of the 48-week data presented at EASL 2026 include:
Pemvidutide 1.8 mg treatment resulted in significant reductions in serum lipid levels among patients with elevated baseline values versus placebo, including:
Triglycerides reductions of -23.7%Total cholesterol reductions of -15.4% In addition to lipids, pemvidutide 1.8 mg treatment resulted in significant improvements in other metabolic risk factors versus placebo:
Weight loss of 7.5%, continuing throughout treatment with no plateauingReductions in body mass index of -3.0 kg/m2Reductions in waist circumference (a measure of visceral adiposity that is associated with increased cardiovascular risk) of -5.3 cmImprovements in systolic blood pressure of -4.0 mmHg and diastolic blood pressure of -2.2 mmHg Results also showed that the safety profile of pemvidutide was maintained at 48 weeks, and the tolerability profile was generally favorable without dose titration. Approximately 1% of total patients receiving pemvidutide discontinued treatment due to adverse events (AEs). The majority of AEs were mild to moderate, and no imbalances in cardiac AEs were observed with pemvidutide versus placebo. Most gastrointestinal AEs were mild to moderate in severity and predominantly occurred within the first 8 weeks.
Previously reported IMPACT Phase 2b trial results showed the proportion of patients achieving both a ≥0.5 reduction in Enhanced Liver Fibrosis (ELF) and a ≥30% reduction in Liver Stiffness Measurement (LSM) at week 48 was 3.2% with placebo, compared with 27.8% for pemvidutide 1.2 mg (p<0.001) and 32.4% for pemvidutide 1.8 mg (p<0.0001).
“These new 48-week results highlight the breadth of the impact of pemvidutide across some of the most critical cardiometabolic risk factors, including lipids, weight and blood pressure,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “Across multiple analyses, we are seeing consistent data that reinforce our confidence in the unique mechanism of pemvidutide – a balanced 1:1 ratio of glucagon and GLP-1 – and its potential to address significant unmet needs in this patient population. Given the promising findings from the IMPACT Phase 2b trial, we are eager to initiate our PERFORMA Phase 3 trial later this year to further assess the efficacy and safety of pemvidutide in patients with MASH.”
About the IMPACT Phase 2b Study
The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks.
About Pemvidutide
Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss.
The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The RECLAIM Phase 2 trial in AUD completed enrollment in November 2025 and topline data are expected in third quarter 2026. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the second half of 2026.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.
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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 the completed IMPACT and planned PERFORMA Phase 3 trials, the timing of key milestones for the Company’s clinical programs, including the anticipated launch of the PERFORMA Phase 3 trial in MASH, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.
Investor Contact:
Luis Sanay, CFA
Vice President, Investor Relations [email protected]
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
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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 expects a Phase III MASH study launch in 2026 and RECLAIM alcohol-use-disorder data in Q3.ALT reported phase IIb results showing sustained MASH resolution and fibrosis-related improvements.ALT ended April 2026 with about $535 million pro forma cash, supporting operations into 2029. Altimmune (ALT - Free Report) is heading into 2026 with a catalyst-heavy calendar tied to pemvidutide, its lead clinical asset. The setup is straightforward: investors are underwriting pivotal execution in metabolic dysfunction-associated steatohepatitis and looking for proof-of-concept in alcohol-related disease programs.
That concentration can create outsized upside on good news and sharp downside on missteps.
ALT’s Near-Term Setup Centers on Two 2026 EventsThe first key milestone is the planned start of a global phase III registrational study in metabolic dysfunction-associated steatohepatitis in the second half of 2026, targeting patients with moderate-to-severe liver fibrosis. Management expects 52-week data in 2029, but the 2026 start is the gating event that moves pemvidutide into a pivotal setting.
The second 2026 catalyst is top-line phase II data from the RECLAIM study in alcohol use disorder, expected in the third quarter of 2026. Enrollment for RECLAIM was completed in November 2025, ahead of schedule, which keeps the timeline intact heading into next year.
A third marker investors may watch is enrollment progress in the RESTORE phase II study in alcohol-associated liver disease. Enrollment is expected to be completed by the third quarter of 2026, providing another read on execution even before efficacy data is available.
Altimmune’s MASH Thesis Depends on Pivotal ExecutionThe phase III PERFORMA start matters because it is the step that turns phase II signals into a program designed for registration. Altimmune has highlighted alignment with the Food and Drug Administration on key late-stage parameters, which helps reduce design uncertainty as the company moves into PERFORMA.
The stakes are high because the company’s value proposition is heavily tied to pemvidutide across multiple indications. That dependence cuts both ways: success can validate a “pipeline in a product” narrative, while failure in a pivotal metabolic dysfunction-associated steatohepatitis program would likely be a major downside catalyst given how central pemvidutide is to the investment case.
That binary profile is also why 2026 is so important. Even without clinical readouts from PERFORMA in 2026, simply initiating the study on time can support confidence that the timeline toward 2029 data remains credible.
ALT’s Phase II Evidence Investors Are Leaning OnIn the phase IIb IMPACT study, pemvidutide delivered statistically significant metabolic dysfunction-associated steatohepatitis resolution without worsening fibrosis at 24 weeks, and that response was sustained through 48 weeks. The company also pointed to clear signs of reducing liver scarring by 48 weeks, alongside continued improvement in markers of liver damage and inflammation.
Top-line 48-week results highlighted statistically significant reductions versus placebo in non-invasive markers of liver fibrosis, including Enhanced Liver Fibrosis and liver stiffness, with improvements that deepened from the 24-week mark.
The dataset also included metabolic benefits, reductions in liver fat and inflammation markers, and meaningful weight loss. Notably, the higher-dose group (1.8 mg) showed weight reduction through 48 weeks without plateauing, while tolerability remained favorable with low discontinuation rates and no serious treatment-related adverse events reported.
Altimmune’s Cash Runway Into 2029 Lowers Timing RiskAltimmune’s financial position improved into the first quarter of 2026, with cash, cash equivalents and short-term investments of $332 million as of March 31, 2026 versus $274 million as of Dec. 31, 2025.
The company raised $75 million in a registered direct offering and $8 million via an at-the-market program in January to February 2026 and then completed an oversubscribed public offering in April 2026 with $225 million in gross proceeds. Pro forma cash was roughly $535 million as of April 30, 2026.
Management expects that cash runway to support operations into 2029, which can lower timing risk by reducing near-term funding pressure as the company advances phase III plans in metabolic dysfunction-associated steatohepatitis and continues its phase II alcohol use disorder and alcohol-associated liver disease trials.
ALT’s Dilution and Financing Overhang Still ExistsEven with a strengthened balance sheet, Altimmune remains a pre-revenue clinical-stage biotech with no marketed products, which keeps external financing central to its operating model.
That reality can translate into dilution risk over time. The company has indicated it may still raise additional funds if market conditions are favorable, a reminder that opportunistic capital raises can remain part of the story even with a longer runway.
Altimmune’s Competition Checklist for BuyersCompetition is a key constraint on upside across all three target areas. In metabolic dysfunction-associated steatohepatitis, pemvidutide faces a crowded field spanning GLP-1 drugs and combination incretins, FGF-21 therapies, thyroid hormone receptor beta agonists, and other emerging mechanisms. Major competitors include Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , alongside metabolic dysfunction-associated steatohepatitis-focused developers such as Madrigal Pharmaceuticals (MDGL - Free Report) and Viking Therapeutics (VKTX).
In alcohol-associated liver disease, large pharmaceutical companies are pursuing multiple approaches, including FGF-21, GLP-1 and RNA-based programs. In alcohol use disorder, pemvidutide would compete with approved options like Vivitrol as well as generic therapies including naltrexone and acamprosate. The net effect is that even strong data may not automatically translate into clear commercial leadership.
ALT’s Valuation Snapshot and What It ImpliesOn a relative basis, the stock has been framed through trailing 12-month book value per share. ALT recently traded at 1.24 times trailing book value, compared with 1.39 times for the Zacks sub-industry, 3.71 times for the Zacks sector, and 8.01 times for the S&P 500.
Over the past five years, the book value multiple has ranged from 0.71 times to 5.25 times, with a five-year median of 2.34 times. That context suggests the current multiple sits below the longer-term midpoint, but still within a historical band.
The stated $3 price target approach is tied to a 1.4 times trailing 12-month book value multiple. In practical terms, that framework implies expectations for performance that tracks more “in-line” outcomes than a high-conviction upside scenario, placing even more emphasis on 2026 execution as the driver of sentiment.
Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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.
Key Takeaways ALT's pemvidutide showed significant MASH resolution in phase IIb, sustained through 48 weeks.ALT plans to start the global Phase III PERFORMA study in the second half of 2026.ALT expects 2026 phase II data in alcohol use disorder and alcohol-associated liver disease. Altimmune (ALT - Free Report) is building its investment case around a single clinical asset with multiple shots on goal in liver disease. Pemvidutide sits at the center of that thesis, with mid-stage data in metabolic dysfunction-associated steatohepatitis and active studies in alcohol-related conditions.
For investors, the story is simple: execution on the next wave of clinical milestones, paired with enough capital to reach them, can define the stock’s setup into 2026 and beyond.
ALT’s Liver Disease Focus and Why It MattersAltimmune is a late clinical-stage biotechnology company focused on therapies for liver diseases. The company is incorporated in Delaware and headquartered in Gaithersburg, MD.
It has not generated product sales revenue to date. Operations have been funded through equity, debt and grants, leaving the business reliant on external capital while it advances clinical development.
That funding model matters because the value of the equity is closely tied to clinical progress, particularly progress tied to pemvidutide. With revenues still minimal and inconsistent, the stock can be sensitive to trial outcomes and timelines.
Altimmune’s Pemvidutide Is a “Pipeline in a Product”Pemvidutide is Altimmune’s lead candidate and the company’s core value driver. It is being developed across three serious liver-related indications: metabolic dysfunction-associated steatohepatitis, alcohol use disorder, and alcohol-associated liver disease.
Management has positioned pemvidutide as a “pipeline in a product” because the same molecule is intended to address multiple disease settings that share metabolic and hepatic injury pathways. The company has also indicated it may evaluate additional indications that leverage pemvidutide’s profile.
This concentration creates leverage both ways. A successful pivotal program in metabolic dysfunction-associated steatohepatitis can expand strategic options, including partnering interest, but the company is also heavily dependent on one drug.
ALT’s Dual Glucagon and GLP-1 Design in Plain EnglishPemvidutide is designed as a balanced 1:1 dual agonist that activates both glucagon and glucagon-like peptide-1 receptors. Altimmune’s thesis is that combining these two pathways in a single molecule can improve liver and metabolic outcomes more broadly than a single-pathway approach.
In plain terms, glucagon activity is intended to work directly on the liver and may help reduce liver fat, inflammation, and scarring. The glucagon-like peptide-1 component is intended to support weight loss by reducing appetite, with potential anti-inflammatory benefits as well.
Altimmune believes that pairing these effects can address multiple aspects of liver disease at once, while also driving weight loss that can matter clinically for patients with metabolic dysfunction-associated steatohepatitis.
Altimmune’s EuPort Tech and Tolerability AnglePemvidutide uses Altimmune’s proprietary EuPort technology, which is designed to slow how the drug is absorbed. The company’s rationale is that slower absorption may improve tolerability.
Altimmune has highlighted the potential for reduced gastrointestinal side effects, a common challenge with therapies that act on glucagon-like peptide-1 biology. Better tolerability can support persistence on therapy, which can be important for longer-duration liver endpoints.
The company has also pointed to simple dosing as a potential adherence advantage versus more complex injectable regimens, which could matter if pemvidutide moves into larger, global trials.
ALT’s MASH Data Readout and the Phase III PathIn its phase IIb IMPACT study, pemvidutide achieved statistically significant metabolic dysfunction-associated steatohepatitis resolution without worsening of fibrosis at 24 weeks, and the response was sustained through 48 weeks.
By 48 weeks, Altimmune reported signs consistent with antifibrotic activity, alongside continued improvement in markers tied to liver damage and inflammation, with the added benefit of weight loss.
Altimmune has stated it reached alignment with the Food and Drug Administration on key parameters for a late-stage study. The company expects to initiate the global phase III registrational PERFORMA study in the second half of 2026, with 52-week data anticipated in 2029.
Altimmune’s AUD and ALD Catalysts for 2026Beyond metabolic dysfunction-associated steatohepatitis, pemvidutide is being evaluated in separate phase II programs in alcohol-related disease, which Altimmune views as significant unmet-need markets.
For alcohol use disorder, the RECLAIM phase II study completed enrollment in November 2025. Altimmune expects top-line data in the third quarter of 2026, setting up a clear catalyst window next year.
For alcohol-associated liver disease, the RESTORE phase II study began in July 2025, and enrollment is expected to be completed by the third quarter of 2026. Together, these readouts broaden the 2026 news flow beyond the metabolic dysfunction-associated steatohepatitis pivotal setup.
ALT’s Regulatory Tailwinds and What They SignalThe Food and Drug Administration granted Fast Track designation to pemvidutide for metabolic dysfunction-associated steatohepatitis and alcohol use disorder, and Breakthrough Therapy Designation for metabolic dysfunction-associated steatohepatitis.
These designations generally reflect the seriousness of the conditions and the unmet medical need, while also signaling that regulators see enough potential benefit to support development efficiency. They do not remove execution risk, but they can help keep timelines clearer as trials scale.
Competition remains intense, including large players such as Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , both currently carrying Zacks Rank #3 (Hold). For ALT, the near-term focus is whether pemvidutide’s multi-indication strategy translates into durable, registrational-quality outcomes across liver disease.
Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT management used an appearance at the Goldman Sachs Global Healthcare Conference to outline the company’s focus on pemvidutide, its lead metabolic and liver disease drug candidate, and to discuss the planned Phase 3 program in metabolic dysfunction-associated steatohepatitis, or MASH.
Jerry Durso, Altimmune’s president, CEO and chairman, said pemvidutide was the primary reason he joined the company, first as a board member last year and then as CEO at the beginning of this year. Durso said the drug’s combination of GLP-1 activity and glucagon activity made it “uniquely suited for liver disease,” with the GLP component targeting metabolic factors such as weight loss and the glucagon component providing what he described as direct activity on the liver.
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How Altimmune Could Grab a Big Chunk of the GLP-1 MarketDurso also highlighted pemvidutide’s proprietary EuPort domain, which he said could be an important contributor to tolerability. He said Altimmune’s current strategy emphasizes liver disease as the primary focus for the asset.
Management Highlights Strategic Priorities Durso said Altimmune’s priorities over the past year have included strengthening the company’s management team, preparing for late-stage development, refining how it communicates pemvidutide’s potential differentiation and positioning the company financially for a Phase 3 program.
This Small Cap Wealth Management Stock Could Provide Big ReturnsGreg Weaver, Altimmune’s CFO, said the company has raised “approaching $500 million” over the past 18 months. He noted that MASH trials can cost in the range of $400 million and said Altimmune is now “well-positioned” with additional optionality if needed.
Weaver also said investor engagement and clearer messaging around Altimmune’s focus on MASH and liver disease have been important as the company prepares for its next stage of development.
Pemvidutide’s Role in a Developing MASH Market Durso said the MASH treatment market is maturing, with the first approved therapies now available and more mechanisms expected to enter the market. He said the disease’s complexity likely means multiple mechanisms and combinations will be needed over time.
Durso said Altimmune is thinking about where pemvidutide could fit in a future market with more treatment options, rather than only the current market. He pointed to potential patient segments including those who may have difficulty tolerating other therapies, patients at risk of sarcopenia and patients who may benefit from a simpler titration schedule.
He also said pemvidutide could become a potential combination partner because of what the company believes could be a favorable safety and tolerability profile, along with a simple titration approach.
Phase 2 Data and Differentiation Durso reviewed prior Phase 2 MASH results, saying pemvidutide showed early activity on MASH resolution at 24 weeks. While the company did not see statistical significance on fibrosis by biopsy at 24 weeks, Durso said non-invasive tests suggested antifibrotic activity was already emerging.
At 48 weeks, he said Altimmune saw improvement across non-invasive tests, including FibroScan and ELF, and that the company believes 52 weeks is the appropriate time point for a biopsy-based fibrosis readout in Phase 3. Durso noted there was no biopsy at 48 weeks in the Phase 2 program.
Durso also highlighted adherence and tolerability, saying pemvidutide had an “extremely low discontinuation rate” in the 48-week data and that more patients stayed on the 1.8 milligram dose than on placebo. He compared that with Phase 2 MASH data for survodutide, saying that program had a discontinuation rate above 20%.
Durso said pemvidutide has a one-to-one ratio of glucagon and GLP-1 agonism, while survodutide is more weighted toward GLP-1 activity. He said the ratio, the molecule itself and the EuPort domain may all be relevant to tolerability and differentiation within the glucagon/GLP-1 class.
Phase 3 MASH Trial Plans Altimmune’s planned Phase 3 MASH program will include a 52-week interim histology readout that Durso said could support an accelerated approval filing, along with a longer-term outcomes component. The study will evaluate two doses of pemvidutide: 1.8 milligrams and 2.4 milligrams.
Durso said the 1.8 milligram dose is supported by the Phase 2 data, while the 2.4 milligram dose offers potential upside on efficacy and in certain subpopulations. The Phase 3 trial will include a simple one- or two-step titration over four or eight weeks, depending on dose.
The study will include biopsy-proven F2 and F3 MASH patients, as well as a separate cohort of NIT-screened F2 and F3 patients. Durso said the biopsy cohort will support the 52-week efficacy analysis, while both cohorts together will contribute to the safety database and longer-term outcomes analysis.
Durso said the trial will be the first Phase 3 program to use the AIM-MASH AI Assist tool, which is intended to support pathologists in histology reads and reduce variability. He said Altimmune continues to guide for patient enrollment to begin in the second half of the year, with a readout anticipated in 2029. He said MASH trials typically take 18 to 24 months to enroll, and Altimmune is targeting the lower end of that range.
Alcohol Use Disorder and Alcohol-Associated Liver Disease Durso also discussed pemvidutide’s development in alcohol use disorder, or AUD, and alcohol-associated liver disease, or ALD. He said Altimmune sees a rationale for the drug in these areas because it may address both drinking behavior through GLP-1-related effects on craving and liver-related effects through its glucagon activity.
The company expects Phase 2 data in AUD next quarter. Durso said the primary endpoint is a reduction in the number of heavy drinking days, with additional measures including liver enzymes, weight and secondary endpoints such as World Health Organization classification.
Durso said there are about 12 million people with AUD and roughly half that number with ALD, with no approved drugs in ALD and only older options in AUD. Weaver said that if Phase 3 development in AUD or ALD is supported by the data, Altimmune would likely prefer non-dilutive financing options, which could include a partner, strategic transaction or regional arrangement.
About Altimmune NASDAQ: ALTAltimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions.
Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose.
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