Abivax S.A.

Abivax to Present Data on Obefazimod at United European Gastroenterology (UEG) Week 2026

Abivax announced seven accepted abstracts on obefazimod, including four oral presentations, at UEG Week 2026 in Barcelona, October 17-20. The data span the Phase 3 ABTECT Maintenance and Induction trials in ulcerative colitis, 3-year interim Phase 2 follow-up after dose de-escalation to 25 mg, and preclinical anti-fibrotic and anti-tumor findings. No new efficacy data are disclosed in this release; the presentations may incrementally support the obefazimod regulatory narrative ahead of potential approval.

•1mo ago

Abivax Presents Business Updates and First Half 2026 Financial Results 

Abivax reported first half 2026 results with €402.4 million in cash, cash equivalents and short-term investments at June 30, 2026, which combined with €767.1 million in net proceeds from the early-July underwritten offering provides a cash runway into Q4 2029. Chris Rabbat will succeed Fabio Cataldi as Chief Medical Officer when Cataldi departs in Q4 2026, and Tim Kelly joins as Chief Technical Officer to lead commercial CMC, Quality and IT ahead of potential obefazimod commercialization. The half-year net loss widened to €165.9 million from €100.8 million as R&D spending rose €29.9 million to €107.9 million, ahead of a planned NDA submission for obefazimod in ulcerative colitis by end of 2026. Abivax completed a $90 million repurchase of all outstanding royalty certificates in Q2 2026 ($45 million cash, $45 million equity), removing the royalty overhang while keeping the balance sheet debt-free.

•1mo ago

Abivax Announces Positive Pre-NDA Interaction with the FDA for Obefazimod

Abivax completed a positive pre-NDA interaction with the FDA for obefazimod, securing alignment on the submission strategy for its lead asset targeting ulcerative colitis. The company confirmed it remains on track to submit its first New Drug Application by the end of 2026, supported by positive Phase 3 data from the ABTECT program. This milestone de-risks the regulatory pathway for obefazimod, reinforcing the potential for a first-in-class therapy to stabilize immune response in chronic inflammatory diseases.

•3mo ago

Abivax Strengthens Commercial Capabilities With Strategic Leadership Appointments

Abivax expanded its Commercial Leadership Team with four strategic appointments to strengthen its organization ahead of the potential U.S. commercialization of obefazimod. The new hires bring decades of experience from major pharmaceutical companies like AbbVie, Takeda, and Amgen, specifically in the inflammatory bowel disease and immunology sectors. The company remains on track for a planned New Drug Application submission for obefazimod in the fourth quarter of 2026 for the treatment of ulcerative colitis.

•3mo ago

Abivax Announces Closing of $920 Million Public Offering

Abivax closed a public offering of 7,360,000 ADSs, raising aggregate gross proceeds of $920.0 million, which includes the full exercise of the underwriters' option. The estimated net proceeds of approximately $874.1 million, together with existing cash, will fund operations into the fourth quarter of 2029. This capital injection supports the clinical-stage development of lead drug candidate obefazimod for ulcerative colitis.

•3mo ago

Abivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $920M (€807M)

Abivax announced the full exercise of the underwriters' option to purchase 960,000 additional ADSs, increasing the total offering size to 7,360,000 ADSs and gross proceeds to approximately $920.0 million. The offering was priced at $125.00 per ADS, a 2.39% premium to the three-day volume-weighted average price, resulting in estimated net proceeds of roughly $874.1 million. The company intends to use the capital for the potential commercialization of obefazimod and to fund Phase 3 clinical trials for ulcerative colitis and Crohn's disease.

•4mo ago

Correction: Abivax Announces Pricing of Highly Oversubscribed and Upsized $800M (€702M) Public Offering of American Depositary Shares

Abivax priced an upsized $800M public offering at $125.00 per ADS, representing a 2.39% premium to the three-day VWAP. The offering size was increased from $600M due to oversubscription, with proceeds expected to extend the company's cash runway into Q2 2029. Funds will support the potential commercialization of obefazimod and clinical development for ulcerative colitis and Crohn's disease.

•4mo ago

Abivax Announces Pricing of Oversubscribed and Upsized $800M (€702M) Public Offering of American Depositary Shares

Abivax priced an upsized $800M public offering of 6.4 million American Depositary Shares at $125.00 per ADS, representing a 2.39% premium to the three-day VWAP. Net proceeds are expected to extend the company's cash runway into the second quarter of 2029, funding the potential commercialization of obefazimod and continued clinical development. The offering was oversubscribed, leading to an increase from the previously announced $600M size, and underwriters were granted a 15% option to purchase additional shares.

•4mo ago

Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database

Abivax reported positive topline results from the ABTECT Maintenance Part 2 trial, showing that 37.2% of induction non-responders achieved clinical remission with continued 50 mg obefazimod treatment. Integrated safety data across 1,704 patient-years indicated malignancy rates consistent with expected background rates for ulcerative colitis, with no new safety signals emerging in the expanded dataset. Management confirmed that the company remains on track to submit a New Drug Application for obefazimod in the fourth quarter of 2026.

•4mo ago

Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis

Abivax reported positive Phase 3 maintenance trial results for obefazimod in ulcerative colitis, with both 25 mg and 50 mg doses meeting the primary endpoint of clinical remission at Week 44. The 25 mg dose achieved a 50.8% remission rate and the 50 mg dose 51.3%, compared to 10.4% for placebo, with p-values <0.0001. Both doses also met all key secondary endpoints, including endoscopic improvement and remission. The drug demonstrated a favorable safety profile with no new safety signals. Abivax plans to submit a New Drug Application to the FDA in late Q4 2026.

•5mo ago

Abivax Announces Repurchase of Royalty Certificates and Pricing of $45M (€38.5M) Offering of American Depositary Shares

Abivax announced a $90 million repurchase of outstanding royalty certificates, funded by $45 million in cash and a $45 million registered direct offering to the certificate holders. The offering consists of 403,347 American Depositary Shares priced at $111.57, equal to the five-day volume-weighted average price, resulting in approximately 0.5% dilution. Management expects the transaction to eliminate the royalty overhang and simplify the capital structure while maintaining a cash runway into Q4 2027.

•5mo ago