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ABIVAX Société Anonyme (ABVX) to Present Phase 3 UC Data at UEG Congress, Investor Call Scheduled
Yahoo Finance· 2025-09-30 16:47
Core Insights - ABIVAX Société Anonyme is recognized as one of the 12 best performing healthcare stocks currently available for investment [1] - The company is focused on developing therapies for chronic inflammatory diseases, with its lead candidate, obefazimod, in advanced clinical trials [1] Group 1: Clinical Development - ABIVAX is a clinical-stage biotechnology company developing obefazimod, an oral miR-124 enhancer, which is currently in Phase 3 trials for ulcerative colitis (UC) and Phase 2b trials for Crohn's disease [1] - In July 2025, ABIVAX reported positive topline data from two Phase 3 induction trials in moderate to severe UC, showing a pooled clinical remission rate 16.4% higher than placebo, with the 50 mg dose achieving a 19.3% placebo-adjusted remission rate [3] - The company plans to submit U.S. and European regulatory applications in the second half of 2026 based on ongoing maintenance studies [3] Group 2: Upcoming Events - ABIVAX announced it will present late-breaking data from the ABTECT Phase 3 induction trials at the United European Gastroenterology (UEG) Congress in Berlin on October 6, 2025 [2] - The presentation will focus on eight-week efficacy results of obefazimod, including outcomes in patients who previously did not respond to advanced therapies [2] - An investor call and symposium on new treatment mechanisms for UC will be hosted alongside the congress [2] Group 3: Financial Position - To support its late-stage programs, ABIVAX strengthened its financial position with a $650 million (€554 million) public offering in July 2025 [4] - This funding extends the company's cash runway into the fourth quarter of 2027, enhancing investor confidence as it advances obefazimod toward potential approval and commercialization [4]
Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting
Globenewswire· 2025-09-29 20:05
Core Insights - Abivax announced the acceptance of an additional late-breaking abstract for its lead drug candidate, obefazimod, to be presented at the 2025 United European Gastroenterology Congress, highlighting its significance in treating moderately to severely active ulcerative colitis [1][2] Group 1: Presentation Details - The late-breaking abstract titled "EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" will be presented on October 5, 2025, at 5 PM CEST [1] - The presentation will include results from two Phase 3 randomized, double-blind, placebo-controlled, 8-week induction trials (ABTECT-1 & 2) [1][3] Group 2: Clinical Significance - The results from the ABTECT Phase 3 induction trials demonstrate statistically significant and clinically meaningful activity, along with an impressive safety and tolerability profile for obefazimod [2] - These findings are seen as crucial steps towards providing a novel, first-in-class oral treatment option for patients with ulcerative colitis [2] Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapies that stabilize the immune response in patients with 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 Announces Presentation of Late-Breaking Abstract for Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting
Globenewswire· 2025-09-23 20:05
Core Insights - Abivax announced the presentation of a late-breaking abstract for its lead drug candidate, obefazimod, at the United European Gastroenterology Congress, highlighting its potential as a new treatment for moderately to severely active ulcerative colitis [2][3] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing innovative therapies for chronic inflammatory diseases, with obefazimod (ABX464) currently in Phase 3 clinical trials for ulcerative colitis [10] Upcoming Events - The late-breaking abstract titled "EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES" will be presented on October 6, 2025, at 10 AM CET [7] - Abivax management will hold an analyst and investor call on October 6 at 3 PM CET to discuss the data [8] - A symposium titled "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" will take place on October 6 from 5:30 PM to 6:30 PM CET [8]
Abivax to Join CAC Mid 60 and SBF 120 Indices Following Euronext Paris Annual Review
Globenewswire· 2025-09-12 15:45
Core Viewpoint - Abivax has been admitted to the CAC Mid 60 and SBF 120 indices on Euronext Paris, enhancing its visibility and accessibility to institutional investors and index-linked funds [1][2][3]. Group 1: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the inflammatory response in patients with chronic inflammatory diseases [1][4]. - The company's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [4]. Group 2: Market Impact - Inclusion in the CAC Mid 60 and SBF 120 indices is expected to broaden Abivax's investor base and enhance its market presence [2]. - The decision to include Abivax in these indices reflects the financial markets' confidence in the company's strategic vision and execution capabilities [3].
Abivax Presents First Half 2025 Financial Results
Globenewswire· 2025-09-08 20:00
Core Viewpoint - Abivax SA reported a significant decline in total operating income and an increase in operating loss for the first half of 2025, highlighting challenges in its financial performance while continuing to advance its clinical programs [2][3][5]. Financial Highlights - Total operating income for the first half of 2025 was €2.1 million, down from €6.8 million in the same period of 2024, representing a decrease of €4.7 million [3][5]. - Total operating expenses increased, with research and development (R&D) costs rising to €77.9 million from €64.7 million, an increase of €13.2 million [3][5]. - The operating loss for the first half of 2025 was €93.7 million, compared to €80.0 million in the first half of 2024, reflecting an increase of €13.7 million [3][5]. Cash Position - As of June 30, 2025, the company's net financial position was €(20.2) million, a decrease of €73.6 million from €53.4 million at the end of 2024 [3][5]. - Available cash and cash equivalents decreased to €60.9 million from €144.2 million, a reduction of €83.3 million [3][5]. Recent Developments - On July 28, 2025, Abivax completed a public offering that raised approximately $747.5 million (about €637.5 million) before expenses, which is expected to support its financial needs [5][6]. - The company anticipates that its existing cash and the proceeds from the public offering will fund its operations into the fourth quarter of 2027 [7]. Clinical Programs - Abivax's lead drug candidate, obefazimod, is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis, indicating ongoing commitment to its therapeutic development [8].
Abivax Announces Closing of $747.5 Million Public Offering
GlobeNewswire News Room· 2025-07-28 20:15
Core Viewpoint - Abivax SA has successfully closed a public offering of 11,679,400 American Depositary Shares (ADSs), raising approximately $747.5 million, which will support its operations and clinical trials through 2027 [1][2]. Group 1: Offering Details - The public offering included the full exercise of the underwriters' option, resulting in gross proceeds of approximately $747.5 million, or €637.5 million, before expenses [1]. - Estimated net proceeds from the offering, after deducting underwriting commissions and expenses, are approximately $700.3 million, equivalent to €597.2 million [1]. - The offering was managed by Leerink Partners, Piper Sandler & Co., and Guggenheim Securities, with LifeSci Capital as the lead manager [3]. Group 2: Financial Outlook - The company anticipates that the net proceeds, along with existing cash and cash equivalents, will finance operations into the fourth quarter of 2027, providing a 12-month cash runway post-NDA submission for Ulcerative Colitis, contingent on positive Phase 3 trial results [2]. Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response for chronic inflammatory diseases, with its lead drug candidate, obefazimod (ABX464), currently in Phase 3 trials for ulcerative colitis [5].
Abivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $747.5M (€637.5M)
GlobeNewswire· 2025-07-25 06:00
Core Viewpoint - Abivax SA has successfully completed an offering of American Depositary Shares (ADSs), raising gross proceeds of approximately $747.5 million (€637.5 million) following the full exercise of the underwriters' option to purchase additional ADSs [1][2]. Group 1: Offering Details - The offering included a total of 11,679,400 ADSs, with gross proceeds of approximately $747.5 million (€637.5 million) and estimated net proceeds of around $700.3 million (€597.2 million) after deducting underwriting commissions and offering expenses [2]. - The offering price for the additional ADSs was set at $64.00 per ADS, which corresponds to €54.58 per ordinary share, reflecting a premium of 21.0% over the volume weighted average price of the ordinary shares in the preceding trading sessions [4]. Group 2: Use of Proceeds - The company intends to apply the net proceeds from the sale of the additional ADSs on a pro rata basis to the uses identified in the base offering [3]. Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in patients with chronic inflammatory diseases, with its lead drug candidate, obefazimod (ABX464), currently in Phase 3 clinical trials for ulcerative colitis [7].
Abivax: Positive Obefazimod Induction Data Leads To Next 44-Week Maintenance Trial Catalyst
Seeking Alpha· 2025-07-24 20:20
Core Insights - Abivax (NASDAQ: ABVX) shares experienced a significant increase of 500% on July 23, 2025, due to the company achieving positive data in its clinical trials [2]. Company Analysis - Abivax is involved in the biotechnology sector and has recently reported promising results that have led to a substantial rise in its stock price [2]. - The company is part of a broader analysis service that includes a library of over 600 biotech investing articles and a model portfolio focused on small and mid-cap stocks [2].
Abivax announces trading resumption of its ordinary shares on Euronext Paris
Globenewswire· 2025-07-24 12:40
Core Viewpoint - Abivax SA has resumed trading of its ordinary shares on Euronext Paris following a halt related to a public offering of American Depositary Shares [1][2]. Group 1: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in patients with chronic inflammatory diseases [3]. - The company's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for treating moderately to severely active ulcerative colitis [3]. Group 2: Trading Information - Trading of Abivax's ordinary shares was halted on July 24, 2025, at 9:00 a.m. CEST at the company's request to facilitate a public offering in the United States [2]. - The trading resumed at 3:30 p.m. CEST on the same day [1].
Abivax Announces Pricing of $650M (€554M) Public Offering of American Depositary Shares
Globenewswire· 2025-07-24 12:40
Core Viewpoint - Abivax SA has announced a public offering of American Depositary Shares (ADSs) priced at $64.00 per ADS, aiming to raise approximately $650 million to support its clinical development efforts [1][9][10]. Offering Details - The offering consists of 10,156,000 ADSs, each representing one ordinary share with a nominal value of €0.01 [1]. - The offering price reflects a 21.0% premium over the volume weighted average price of the ordinary shares on Euronext Paris over the last three trading sessions prior to pricing [2]. - The offering is managed by Leerink Partners, Piper Sandler & Co., and Guggenheim Securities, with LifeSci Capital as the lead manager [3]. Financial Proceeds - The gross proceeds from the offering are expected to be approximately $650 million, or €554 million, before deducting expenses [9]. - If the underwriters' option to purchase additional shares is fully exercised, total gross proceeds could reach approximately $747.5 million, or €637.5 million [10]. Use of Proceeds - The company plans to use the net proceeds to fund clinical development for its lead drug candidate, obefazimod, targeting ulcerative colitis and Crohn's disease, as well as for general corporate purposes [11][16]. - Specific allocations include approximately $140 million to $185 million for ulcerative colitis, and $30 million to $65 million for Crohn's disease [16]. Closing and Lock-up - The offering is expected to close on July 28, 2025, subject to customary conditions [6]. - Company board members and executive officers are subject to a 60-day lock-up period following the final prospectus supplement [13]. Dilution Impact - The issuance of ADSs will result in a dilution of approximately 16.0% of the company's share capital on a non-diluted basis, increasing to 18.4% if the underwriters' option is exercised [14]. Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in chronic inflammatory diseases, with its lead candidate currently in Phase 3 trials for ulcerative colitis [20].