Welcome to our dedicated page for Abivax S.A. news (Ticker: ABVX), a resource for investors and traders seeking the latest updates and insights on Abivax S.A. stock.
Abivax SA (ABVX) is a clinical-stage biotechnology company pioneering immunomodulatory therapies for chronic inflammatory diseases, with a focus on ulcerative colitis. This page serves as the definitive source for all official company announcements, research developments, and regulatory milestones.
Investors and industry observers will find timely updates on clinical trial progress, partnership agreements, and scientific innovations. Our curated feed includes press releases on phase advancements, peer-reviewed study publications, and strategic corporate decisions impacting Abivax's therapeutic pipeline.
Key updates cover ABVX's lead drug candidate developments, patent filings, and collaborations with medical research institutions. The resource is particularly valuable for tracking progress in inflammatory bowel disease treatments and understanding the company's unique approach to immune system modulation.
Bookmark this page for direct access to unfiltered information from Abivax, ensuring you stay informed about material events in this innovative biotech's journey. Check regularly for new developments in one of biopharma's most promising research sectors.
Abivax has successfully completed enrollment for its Phase 3 ABTECT trials studying obefazimod in patients with moderate to severe ulcerative colitis. The trials exceeded their target by enrolling 1,275 participants (4% above target of 1,224).
Key timeline expectations include:
- Top-line results from 8-week induction trials in Q3 2025
- 44-week maintenance data in Q2 2026
- New Drug Application submission planned for H2 2026
The study's baseline characteristics match the Phase 2b trial profile, with 65% of participants having severe disease (MMS 7-9), 48% experiencing prior advanced therapy failure, and 42% using corticosteroids. The trial spans multiple regions, with significant participation from Eastern Europe (38%), Asia (24%), and Western/Central Europe (22%). The company's cash runway extends through the induction trials readout into Q4 2025.
Abivax (ABVX) has announced its Annual General Meeting scheduled for June 6, 2025, in Paris, France. The company provided updates on its key operational milestones, particularly highlighting the progress of its Phase 3 ABTECT clinical program. Enrollment completion for the ABTECT induction trials is expected in Q2 2025, with top-line induction results anticipated in Q3 2025.
In a show of confidence in the company's future, CEO Marc de Garidel revealed that the executive leadership team, including himself, invested in approximately 120,000 Abivax ordinary shares in Q1 2025. The company, which focuses on developing therapeutics for chronic inflammatory diseases, views 2025 as a potentially transformative year with major clinical readouts approaching.
Abivax (Euronext: ABVX, Nasdaq: ABVX) has appointed Dr. Dominik Höchli to its Board of Directors, effective immediately. Dr. Höchli brings over 20 years of leadership experience in global biopharma, including a significant tenure at AbbVie/Abbott as Vice President of Global Marketing for Immunology and Head of Global Medical Affairs.
The appointment comes at a important time as Abivax approaches its Phase 3 data readout for the 8-week induction trial in ulcerative colitis, expected in Q3 2025. Dr. Höchli's expertise in medical strategy and commercialization within immunology markets will be valuable for the company's development of obefazimod for ulcerative colitis and Crohn's disease.
Dr. Höchli previously served as Interim CEO of Catapult Therapeutics (2021-2024) and currently serves on the Board of Directors at Molecular Partners AG. He is also the founder of Abinode, a pharmaceutical strategy consulting firm.
Abivax (ABVX) has announced the filing of its Universal Registration Document with the French Financial Market Authorities (AMF) and its Annual Report (20-F) with the U.S. Securities and Exchange Commission (SEC) on March 24, 2025.
The Universal Registration Document contains the 2024 annual financial report, management report including corporate governance report, and statutory auditors' reports. These documents will be accessible on Abivax's website, AMF, and SEC's EDGAR system.
Abivax is a clinical-stage biotech company developing treatments for chronic inflammatory diseases. Their lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for treating moderately to severely active ulcerative colitis.
Abivax (ABVX) has released its full-year 2024 financial results, reporting a cash balance of EUR 144.2M as of December 31, 2024, providing runway into Q4 2025. The company's operating income increased to EUR 12.5M, up from EUR 4.6M in 2023.
R&D expenses rose to EUR 146.5M, primarily due to the advancement of Phase 3 ABTECT clinical trials for obefazimod in ulcerative colitis (UC). G&A expenses increased to EUR 32.9M, reflecting organizational growth and dual-listing costs. The company reported a EUR 3.3M net financial loss.
Key upcoming milestones include:
- Full enrollment in Phase 3 ABTECT trial expected in Q2 2025
- Top-line results from 8-week induction trials anticipated in Q3 2025
- Completion of 44-week maintenance trial in Q2 2026
Abivax (ABVX) has announced a Key Opinion Leader (KOL) Investor Webcast scheduled for March 17, 2025, at 9:00 a.m. EDT (2:00 p.m. CET). The virtual event will feature Professor David T. Rubin, MD, Chief of Gastroenterology at The University of Chicago and Director of their Inflammatory Bowel Disease Center.
The webcast will focus on the ulcerative colitis (UC) treatment landscape and Abivax's ABTECT Phase 3 trial of obefazimod in adults with moderately to severely active UC. Dr. Rubin will discuss obefazimod's potential to address unmet medical needs in UC treatment.
The event will conclude with a live Q&A session featuring Dr. Rubin and Abivax's management team. Interested participants can register for the webcast through the provided link: https://lifescievents.com/event/abivax-3/.
Abivax (Euronext: FR0012333284 – ABVX / Nasdaq: ABVX), a clinical-stage biotechnology company focused on developing therapies for chronic inflammatory diseases, has announced its 2025 financial communications calendar. The schedule includes:
- March 24, 2025: 2024 Annual Business and Financial Report, Universal Registration Document, and Annual Report on Form 20-F
- June 2, 2025: 2025 Q1 Financial Results
- June 6, 2025: Annual General Meeting in Paris
- August 11, 2025: 2025 Half-Year Business and Financial Report
- December 15, 2025: 2025 Q3 Financial Results
All financial reports will be released after US market closure and will include corresponding regulatory filings for both Euronext and US markets.
Abivax (ABVX) announced the presentation of seven scientific abstracts focusing on obefazimod, its lead drug candidate for treating moderately to severely active ulcerative colitis (UC), at the upcoming European Crohn's and Colitis Organization's 20th Annual Congress in Berlin (February 19-22, 2025).
The presentations include one oral presentation on the efficacy and safety of dose de-escalation from 50mg to 25mg QD of obefazimod maintenance treatment, and six poster presentations covering various aspects including histologic outcomes, integrated safety summary, health-related quality of life, long-term efficacy and safety after dose de-escalation, treatment patterns, and synergistic reduction of inflammatory cytokines.
The presentations will feature research from prominent medical experts, including Prof. Silvio Danese, Prof. Séverine Vermeire, and Prof. Parambir S. Dulai, among others.
Abivax (ABVX) has reached a significant milestone in its Phase 3 ABTECT trial for obefazimod, enrolling 1,003 out of 1,224 targeted participants (82%) for treating moderately to severely active ulcerative colitis. The company expects to complete enrollment in Q2 2025, with top-line results for the 8-week induction trial anticipated in Q3 2025.
The 44-week maintenance data is expected in Q2 2026, followed by NDA submission in H2 2026 if successful. The blinded baseline characteristics align with the pre-specified target population and are consistent with the Phase 2b UC trial. The company confirms its cash runway extends through the ABTECT induction trial readout and into Q4 2025, with no additional financing needed.
The trial's safety profile shows no new safety signals under the oversight of the independent Data Monitoring Committee. Obefazimod is being developed as a potentially first-in-class oral treatment option for UC patients.
Abivax announced that Dr. Philippe Pouletty, representative of Truffle Capital, will resign as director effective December 31, 2024. Dr. Pouletty, who served as Chairman of the Board from the company's inception in December 2013 until August 2022, is stepping down due to his recent appointment as Chairman and acting CEO of a French listed biotechnology company in plastics recycling. As CEO of Truffle Capital, he was instrumental in founding Abivax and developing obefazimod, the company's lead drug candidate currently in Phase 3 clinical trials for ulcerative colitis. The Board will initiate a search for a new director to support Abivax's late-stage pipeline development in IBD.
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