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]

Belapectin for MASH Cirrhosis and Portal Hypertension 2 Company introduction Joel Lewis CEO & President June 2025 Today's Agenda | 01 | Moderator Michael Cozart, LifeSci Consulting | | --- | --- | | 02 | Galectin Company Introduction Joel Lewis (CEO & President) | | 03 | Belapectin as Galectin-3 Inhibitor for MASH cirrhosis & Portal Hypertension Khurram Jamil, M.D. (CMO) | | 04 | Unmet Need & Patient Landscape Naga Chalasani, M.D. | | 05 | Khurram | | | Clinical Results – NAVIGATE Trial design & Results Nai ...

NORCROSS, Ga., June 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 12:00 PM ET. To register, click here. The event will focus on the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertens ...

Altimmune (ALT) 2025 Conference June 04, 2025 09:55 AM ET Speaker0 Alright. Welcome everyone to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Song, one of the senior analyst covers Mecha Biotech in The US. It's my great pressure to have the fireside chat with our next presenting company, Altimmune, the CEO of the Pennant and CMO, Scott Harris. Welcome, gentlemen. Speaker1 Thank you. Speaker0 Awesome. Yeah. So, we know know lots eyes on the upcoming phase two MeSH data, But befo ...

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]

Group 1 - The core focus of Inventiva is the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [4] - Inventiva will participate in two investor conferences in June 2025, including the Jefferies Global Healthcare Conference and the UBS Spring Biotech Conference [2][3] - Frédéric Cren, CEO of Inventiva, will present a corporate overview during a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 [2] Group 2 - Inventiva is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for MASH treatment [4] - The company is publicly listed on Euronext Paris and NASDAQ, with the ticker symbol IVA [5]

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 Points - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and announced the results of its Combined Shareholders' Meeting [1][12] - The meeting took place on May 22, 2025, in Paris, chaired by CEO Frédéric Cren [2] - All resolutions were adopted except for the 33rd resolution, which was negatively recommended by the Board of Directors [3] Voting Results - The shareholders present included 245 participants, representing a total of 90,772,892 shares and 102,984,957 votes, achieving a quorum of 65.264% [5] - Ordinary resolutions were overwhelmingly adopted, with the first resolution receiving 99.98% approval [6][10] - The 33rd resolution, which would have allowed the Board to decide on share capital increases for a company savings plan, was rejected with 90.58% against [10][11] Company Overview - Inventiva is publicly listed on Euronext Paris and Nasdaq, focusing on the research and development of oral small molecule therapies for MASH and other unmet medical needs [12][13] - The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial for MASH treatment [12]

Core Viewpoint - The research highlights the critical role of the epigenetic regulator BAZ2B in hepatic senescence and metabolic dysfunction-associated steatohepatitis (MASH) fibrosis, providing a theoretical foundation for developing new therapeutic strategies [2][4][7]. Group 1: Research Findings - The study reveals an epigenetic mechanism linking liver aging to MASH fibrosis, with the upregulation of chromatin remodeler BAZ2B associated with MASH pathology in certain liver cells [4]. - In mouse models, gene knockout or liver cell-specific knockdown of Baz2b alleviates hepatic senescence and MASH fibrosis by maintaining PPARα-mediated lipid metabolism, which is impaired in naturally aged and MASH mice [4][5]. - BAZ2B directly binds to the promoter regions of genes related to the PPARα signaling pathway, reducing chromatin accessibility and downregulating gene expression [5]. Group 2: Implications - The BAZ2B-PPARα-lipid metabolism signaling axis is identified as a crucial link in the progression from liver aging to MASH fibrosis, suggesting that BAZ2B may serve as a potential therapeutic target for liver aging and fibrosis [7].

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, focusing on novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) through a combination therapy approach involving denifanstat and resmetirom [1][2][3] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors targeting metabolic and fibrotic pathways [6][7] - The lead product candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating MASH, which has received Breakthrough Therapy designation from the FDA for non-cirrhotic MASH with moderate to advanced liver fibrosis [7] Upcoming Event - A virtual key opinion leader (KOL) event is scheduled for May 29, 2025, featuring Dr. Rohit Loomba, who will discuss the potential of combining denifanstat with resmetirom for treating advanced MASH [1][2] - The event will include an overview of the planned Phase 1 pharmacokinetic clinical trial for the combination therapy and a live Q&A session [3][4] Clinical Development - The development program builds on positive results from the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly those at the advanced F3 stage [2][3] - Preclinical data indicate a synergistic effect of combining a FASN inhibitor with resmetirom on liver disease markers, showing improved NAS and hepatic collagen content compared to single agents [3] Disease Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [8] - The renaming of non-alcoholic fatty liver disease (NAFLD) to MASH aims to provide a more affirmative diagnosis and reduce stigma associated with the disease [8]