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Abivax Announces Presentation of Seven Abstracts for Obefazimod in Ulcerative Colitis at 2025 European Crohn's and Colitis Organization 20th Annual Congress
GlobeNewswire News Room· 2025-01-23 21:05
Core Insights - Abivax announced the presentation of seven scientific abstracts regarding its lead drug candidate, obefazimod, at the 2025 European Crohn's and Colitis Organization Annual Congress [1][2] - Obefazimod is in clinical development for treating moderately to severely active ulcerative colitis [1][5] Presentation Details - The abstracts will cover various aspects of obefazimod, including efficacy, safety, and quality of life in patients with ulcerative colitis [3][4] - Notable presentations include an oral presentation on dose escalation and multiple poster presentations focusing on treatment impacts and safety profiles [3][4] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapies that stabilize the immune response in chronic inflammatory diseases [5] - The company is based in France and the United States, with obefazimod currently in Phase 3 clinical trials for ulcerative colitis [5]
Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment
GlobeNewswire· 2025-01-09 16:35
Phase 3 ABTECT Trial Progress - The Phase 3 ABTECT trial evaluating obefazimod for moderately to severely active ulcerative colitis (UC) has enrolled 1,003 participants, representing 82% of the targeted 1,224 participants [2][5][6] - Enrollment completion is expected in Q2 2025, with top-line results for the 8-week induction trial anticipated in Q3 2025 [2][5][6] - The 44-week maintenance data is on track for Q2 2026, and if successful, an NDA submission is planned for H2 2026 [5][6] Company Strategy and Financial Position - The company's cash runway extends beyond the expected top-line results from the ABTECT induction trial and into Q4 2025, without the need for additional financing [4][5] - The company believes 2025 will be a pivotal year, with key data readouts and the advancement of its broader portfolio addressing chronic inflammatory conditions [3] Participant and Safety Data - Blinded baseline characteristics of participants align with the pre-specified target population and are consistent with the Phase 2b UC trial [5][6] - No new safety signals have been observed to date, with oversight from the independent Data Monitoring Committee [6] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod (ABX464), in Phase 3 clinical trials for UC [7]
Abivax Announces a Change to the Composition of its Board of Directors
GlobeNewswire· 2024-12-23 21:05
Core Viewpoint - Abivax is undergoing a change in its Board of Directors, with Dr. Philippe Pouletty resigning effective December 31, 2024, to focus on his new role as Chairman and acting CEO of another biotechnology company [4]. Group 1: Board Composition Changes - Dr. Philippe Pouletty, a founder and former chairman of Abivax, has resigned from the Board of Directors, which he has been part of since the company's inception in December 2013 [4][5]. - The company will initiate a search for a new board member to strengthen its leadership as it advances its late-stage pipeline in inflammatory bowel disease (IBD) [5]. Group 2: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the inflammatory response in patients with chronic inflammatory diseases [4][5]. - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [5]. Group 3: Future Expectations - Truffle Capital, a major shareholder, is expected to continue supporting Abivax through significant upcoming milestones, including the anticipated Phase 3 ABTECT data readout in 2025 [4].
Abivax presents third quarter 2024 key financial information
GlobeNewswire News Room· 2024-11-14 21:01
Core Insights - Abivax SA, a clinical-stage biotechnology company, reported its key financial information for Q3 2024, highlighting its focus on developing therapeutics for chronic inflammatory diseases [1][3] Financial Highlights - As of September 30, 2024, Abivax had cash and cash equivalents of EUR 180.5 million, which is expected to fund operations into Q4 2025 [3] - The total principal debt outstanding was EUR 106.3 million, a decrease from EUR 108.4 million as of June 30, 2024 [3][4] Business Updates - Abivax has made significant progress in its clinical trials, including the Phase 3 trial of its lead drug candidate, obefazimod, for ulcerative colitis [2][5] - The company has provided updates on various operational goals and milestones achieved in recent months, including enrollment milestones and interim efficacy results [2]
Abivax Congratulates Victor Ambros and Gary Ruvkun on Their Nobel Prize for the Discovery of microRNA and its Role in Post-Transcriptional Gene Regulation
GlobeNewswire News Room· 2024-10-07 20:01
Core Insights - Abivax congratulates Victor Ambros and Gary Ruvkun for their Nobel Prize in Physiology or Medicine, recognizing their contributions to the understanding of microRNA and gene regulation [1][2] - The company emphasizes its commitment to innovative therapies utilizing microRNA, particularly through its lead candidate obefazimod, which is in advanced clinical trials for chronic inflammatory diseases [2][3] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [4] - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 trials for moderately to severely active ulcerative colitis and has shown positive results in Phase 2 trials [3][4] Product Development - Obefazimod is an orally administered small molecule that enhances the expression of microRNA-124 (miR-124), aimed at reducing inflammation in chronic inflammatory conditions [2][3] - The pivotal global Phase 3 clinical trial program (ABTECT Program) for ulcerative colitis began enrolling patients in October 2022, with a Phase 2b trial for Crohn's disease ongoing as of October 2024 [3]
Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn's Disease
GlobeNewswire News Room· 2024-10-03 20:01
Core Viewpoint - Abivax has enrolled the first patient in its Phase 2b ENHANCE-CD trial for obefazimod, targeting Crohn's disease, marking a significant advancement in treatment options for patients with moderately to severely active conditions [2][3]. Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in chronic inflammatory diseases [6]. - The company's lead drug candidate, obefazimod, is currently in Phase 3 trials for ulcerative colitis and has shown positive results in previous studies [5][6]. Trial Design - The ENHANCE-CD trial consists of three phases: a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase, aimed at evaluating the efficacy and safety of obefazimod compared to placebo [4]. - The primary objective of the 48-week extension phase is to assess the safety and tolerability of obefazimod in subjects who have previously shown inadequate response to conventional therapies [4]. Drug Information - Obefazimod is an orally administered small molecule that may enhance the expression of microRNA miR-124, with ongoing exploration for combination therapy opportunities in ulcerative colitis [5].
Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance
GlobeNewswire News Room· 2024-10-03 06:31
Core Insights - Abivax reported positive interim efficacy and safety results for obefazimod in patients with moderate to severe ulcerative colitis after two years of open-label maintenance treatment [1][2][3] - The treatment demonstrated maintenance of clinical remission and a favorable safety profile, with no new safety signals detected [1][3][4] Efficacy Results - At study baseline, 89% of patients were in clinical remission, with 84% and 87% maintaining remission at weeks 48 and 96, respectively [3] - Symptomatic remission was observed in 92% of patients at baseline, with 91% and 92% at weeks 48 and 96, respectively [3] - The study included 130 patients, with 113 evaluated at 48 weeks and 74 at 96 weeks [2][3] Safety Profile - The treatment was well-tolerated, with a patient retention rate of 88% in the first year and 95% in the second year [3] - Only 12% of patients discontinued in the first year and 5% in the second year, indicating strong adherence to the treatment [3] Future Developments - Abivax is advancing obefazimod into a pivotal global Phase 3 clinical trial program, with the first patients enrolled in the U.S. in October 2022 [5] - A Phase 2b clinical trial in Crohn's disease is expected to begin in Q4 2024, along with ongoing exploration of combination therapy opportunities in ulcerative colitis [5] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in chronic inflammatory diseases [6] - The company is based in France and the United States, with obefazimod as its lead investigational drug candidate [6]
Abivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024
GlobeNewswire News Room· 2024-09-26 06:30
Core Insights - Abivax will present three scientific abstracts on obefazimod at the UEG Week 2024, focusing on its efficacy and safety in treating moderately to severely active ulcerative colitis [1][2] - The presentations will include data from a Phase 2b trial, highlighting the drug's potential to change treatment paradigms for ulcerative colitis patients [2] Company Overview - Abivax is a clinical-stage biotechnology company based in France and the United States, specializing in therapeutics for chronic inflammatory diseases [4] - The lead drug candidate, obefazimod, is currently in Phase 3 clinical trials for ulcerative colitis and has shown positive results in earlier trials [3][4] Drug Development - Obefazimod is an orally administered small molecule that may enhance the expression of microRNA miR-124, with a pivotal global Phase 3 trial program (ABTECT Program) initiated in October 2022 [3] - A Phase 2b clinical trial for Crohn's disease is expected to start in Q3 2024, and the company is exploring combination therapy opportunities for ulcerative colitis [3]
Is Abivax SA Sponsored ADR (ABVX) Outperforming Other Medical Stocks This Year?
ZACKS· 2024-09-13 14:46
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Abivax SA Sponsored ADR (ABVX) one of those stocks right now? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Abivax SA Sponsored ADR is a member of our Medical group, which includes 1019 different companies and currently sits at #4 in the Zacks Sector Rank. The Zacks Sector Rank ...
Wall Street Analysts Believe Abivax SA Sponsored ADR (ABVX) Could Rally 193.62%: Here's is How to Trade
ZACKS· 2024-09-12 14:55
Shares of Abivax SA Sponsored ADR (ABVX) have gained 6.9% over the past four weeks to close the last trading session at $11.75, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $34.50 indicates a potential upside of 193.6%.The mean estimate comprises six short-term price targets with a standard deviation of $13.59. While the lowest estimate of $16 indicates a 36.2% increase from ...