Jason Campagna, MD, PhD, joins Inventiva as President of R&D and Chief Medical Officer, succeeding Pierre Broqua, PhD, and Michael Cooreman, MDMartine Zimmermann, PharmD, joins as Executive Vice President of Regulatory Affairs and Quality AssuranceThese key leadership appointments underscore Inventiva’s commitment to long-term growth and operational excellence, with topline results from NATiV3 on track for the second half of 2026 Daix (France), New York City (New York, United States), July 9, 2025 – Invent ...

Core Insights - Altimmune, Inc. released topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), a severe liver disease [1] Group 1: Trial Details - The Phase 2b trial included 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses, or placebo for 24 weeks [2] - Treatment discontinuation rates were low, with only 9% of participants prematurely discontinuing treatment [3] Group 2: Efficacy Results - In an intent-to-treat (ITT) analysis, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% for pemvidutide 1.2 mg, 52.1% for 1.8 mg, and 19.1% for placebo (p< 0.0001 for both doses) [3] - The effects on fibrosis improvement without worsening of MASH were 31.8% for pemvidutide 1.2 mg, 34.5% for 1.8 mg, compared to 25.9% for placebo, although these differences were not statistically significant [4] Group 3: Analyst Ratings - HC Wainwright reiterated a Buy rating for Altimmune with a price forecast of $12, believing the data supports advancing pemvidutide to Phase 3 and strengthens its case as a potential best-in-class therapy [5] - Conversely, William Blair maintained a Market Perform rating, citing "underwhelming" results and concerns about demonstrating significant fibrosis improvement at the 48-week mark [6] Group 4: Stock Performance - ALT stock is trading lower by 1.80% to $3.545 at last check [7]

Core Insights - Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), demonstrating significant MASH resolution and weight loss at 24 weeks [2][4][5] Study Results - The Phase 2b trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks [3][10] - In an intent-to-treat (ITT) analysis, MASH resolution without worsening of fibrosis was achieved in 59.1% and 52.1% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 19.1% for placebo (p< 0.0001) [3][7] - Fibrosis improvement without worsening of MASH was observed in 31.8% and 34.5% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, versus 25.9% for placebo [3][7] - Weight loss at 24 weeks was 5.0% for the 1.2 mg group and 6.2% for the 1.8 mg group, compared to 1.0% in the placebo group (p< 0.001) [3][7] - Liver fat reductions of 58.0% and 62.8% were achieved in participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, versus 16.2% in the placebo group (p< 0.001) [7][8] Safety and Tolerability - Pemvidutide demonstrated potentially best-in-class tolerability, with less than 1% treatment discontinuations due to adverse events [2][4] - Adverse events leading to treatment discontinuation were 0.0% and 1.2% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 2.4% in the placebo group [3][7] Future Outlook - The company anticipates a successful End of Phase 2 meeting with the FDA in the fourth quarter of 2025, enabling rapid progression to Phase 3 [5][4] - The ongoing IMPACT trial is expected to provide a final readout in the fourth quarter of 2025 [10]

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist targeting the underlying causes of MASH [2] - Rezdiffra is the first and only medication approved by the FDA for treating MASH with moderate to advanced fibrosis, specifically stages F2 to F3 [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis, corresponding to stage F4c [2] Upcoming Events - Madrigal Pharmaceuticals will participate in the 46th Annual Global Goldman Sachs Health Care Conference on June 11, 2025, at 10:40 A.M. EDT [1] - The presentation will be available via live webcast, with a replay accessible after the event [1]

Core Insights - Inventiva reported a decrease in cash and cash equivalents to €67.9 million as of March 31, 2025, down from €96.6 million at the end of 2024, primarily due to cash used in operating activities for the lanifibranor development program [2][3] - The company anticipates that its current cash resources, along with gross proceeds of €115.6 million from structured financing and a $10 million milestone payment from Chia Tai Tianqing Pharmaceutical Group, will fund operations until the end of Q3 2026 [3] - Inventiva did not recognize any revenues in Q1 2025, consistent with Q1 2024 [5] Financial Results - Cash and cash equivalents as of March 31, 2025: €67.9 million, a decrease of €28.7 million from €96.6 million on December 31, 2024 [2] - Gross proceeds from structured financing: €115.6 million, with net proceeds of €108.5 million [3] - Anticipated milestone payment from CTTQ: $10 million [3] Research and Development Updates - The company completed enrollment for its pivotal Phase 3 clinical trial, NATiV3, evaluating lanifibranor in patients with MASH [10] - The company initiated a clinical development program for lanifibranor in Japan with the first participant dosed in a Phase 1 trial [10] - Recent publications include findings on non-invasive biomarker signatures and improvements in portal hypertension with lanifibranor treatment [10] Future Outlook - The company plans to raise additional funds for the long-term development and commercialization of lanifibranor through public offerings, private placements, and strategic partnerships [4] - Topline results from the NATiV3 trial are expected in the second half of 2026 [8]

Core Insights - Madrigal Pharmaceuticals announced positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra, showing significant improvements in liver health metrics among patients with compensated MASH cirrhosis [1][2][3] Group 1: Study Results - The study involved 122 patients, with 113 completing two years of treatment, demonstrating a mean reduction of 6.7 kPa in liver stiffness, which is statistically significant [5][8] - 65% of patients with clinically significant portal hypertension (CSPH) at baseline moved to lower risk categories by year two, indicating a positive shift in patient outcomes [4][8] - Among patients with probable CSPH at baseline, 57% transitioned to the no/low CSPH category, further supporting the efficacy of Rezdiffra [4] Group 2: Safety and Tolerability - Rezdiffra was well-tolerated, with a low discontinuation rate due to adverse events; the most common side effects included diarrhea, COVID-19, and nausea [6][8] - Safety data were consistent with previous studies, reinforcing the drug's favorable safety profile [6] Group 3: Mechanism and Future Trials - Rezdiffra acts as a THR-β agonist, which is mechanistically supported to improve outcomes in patients with compensated MASH cirrhosis [7] - A larger placebo-controlled study is anticipated to confirm the benefits of Rezdiffra in this high-risk population, with ongoing trials expected to provide further insights [2][14] Group 4: Market Context - MASH is projected to become the leading cause of liver transplantation in the U.S., highlighting the urgent need for effective treatments [10][11] - An estimated 1.5 million patients have been diagnosed with MASH in the U.S., with Madrigal targeting approximately 315,000 patients with moderate to advanced fibrosis [12]

Results support potential benefit of efruxifermin (EFX) to elicit fibrosis improvement in patients with compensated cirrhosis (F4 fibrosis) due to MASH 96-week data from SYMMETRY trial presented at EASL Congress 2025 SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced publication of results from the ...

SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, presented results from the Phase 2b SYMMETRY trial demonstrating the potential of efruxifermin (EFX) to improve fibrosis in compensated cirrhosis (F4) caused by metabolic dysfunction-associated steatohepatitis (MASH), in a late-breaking oral presentation at the Eur ...

First-quarter 2025 Rezdiffra™ (resmetirom) net sales of $137.3 million As of March 31, 2025, more than 17,000 patients on Rezdiffra Two-year compensated MASH cirrhosis (F4c) data from MAESTRO-NAFLD-1 trial selected as oral late-breaker at EASL Congress (May 7-10)Appointed David Soergel, M.D., to Chief Medical Officer; Rebecca Taub, M.D., named Senior Scientific and Medical Advisor Appointed Jacqualyn Fouse, Ph.D., to Board of DirectorsReports cash, cash equivalents, restricted cash and marketable securities ...

Core Viewpoint - Viking Therapeutics has experienced a significant decline in stock price in 2025, down 35% year to date, despite a strong performance in 2024 due to promising clinical progress [1][2][3] Group 1: Company Performance - The company's leading candidate, VK2735, an investigational GLP-1 weight loss therapy, showed excellent phase 2 results and is expected to advance to phase 3 studies soon [5] - Viking's market cap is approximately $3 billion, and it is considered one of the more promising bets in the weight loss therapy sector, despite competition from larger companies like Eli Lilly and Novo Nordisk [8][6] - The company is also developing VK2809 for metabolic dysfunction-associated steatohepatitis (MASH), which has also passed phase 2 studies, and VK0214 for X-linked adrenoleukodystrophy, which has completed phase 1 studies [9][10] Group 2: Financial Position - Viking Therapeutics ended the first quarter with $852 million in cash and equivalents, down from $903 million at the end of 2024, indicating a solid financial position to support ongoing studies [11] - The company is expected to access additional funding easily due to its clinical progress, which should mitigate any immediate funding concerns [11] Group 3: Market Context - The weight loss market is experiencing rapid growth, with sales of existing therapies increasing significantly, and analysts predict continued growth in this sector at least until the early 2030s [7] - Despite the influx of investigational weight loss therapies, most have shown modest results, making Viking's promising data stand out in the competitive landscape [8]