Abivax SA filings document the formal U.S. disclosure record of a France-based foreign private issuer and clinical-stage biotechnology company. Form 6-K reports cover current-event disclosures, annual meeting materials, shareholder voting matters, financial results, clinical and regulatory updates for obefazimod, and material agreements tied to the company’s capital structure.
The filing record also includes annual reporting on Form 20-F and references to Form F-3 and Form S-8 registration statements. These documents disclose Abivax’s research-and-development business, ADS and ordinary-share structure, financing activity, governance matters, risk factors, and regulatory reporting obligations in the United States.
Sofinnova-affiliated investors have updated their stake in Abivax S.A. following a royalty buyback deal. As of May 11, 2026, Sofinnova Crossover I SLP directly holds 3,377,494 Ordinary Shares, representing about 4.3% of Abivax’s outstanding Ordinary Shares and 5,499,478 voting rights, or about 6.7% of voting rights.
On May 4, 2026, Abivax repurchased royalty certificates from Sofinnova and other holders for an aggregate $90.0 million, split between $45.0 million in cash and $45.0 million in shares through the issuance of 403,347 Ordinary Shares in a private placement. Sofinnova Crossover I SLP received 42,755 ADSs in this transaction, and Abivax agreed to register these ADSs for resale. The filing also notes that Kinam Hong is no longer on Abivax’s Board of Directors.
Abivax SA agreed to repurchase all of its outstanding royalty certificates for a total of $90 million, paying $45 million in cash and $45 million through issuing 403,347 new American Depositary Shares at $111.57 per ADS.
The royalty certificates will be cancelled, simplifying Abivax’s capital structure. The share issuance represents about 0.5% dilution; a 1% holder would move to roughly 0.99%. Abivax reported cash, cash equivalents and short-term investments of €530.4 million as of December 31 2025, supporting a projected cash runway into Q4 2027, which remains unchanged after this transaction. Abivax also filed a prospectus supplement to register potential resales of up to 403,347 ADSs held by the former royalty certificate holders.
Abivax SA is registering the offer and resale of up to 403,347 ADSs, each representing one ordinary share, for sale by the selling shareholders under a prospectus supplement. The ADSs were issued as part of a repurchase of royalty certificates for an aggregate consideration of $90.0 million, consisting of $45.0 million paid in cash and $45.0 million paid by issuance of 403,347 ordinary shares/ADSs. The company states it will not receive any proceeds from resale by the selling shareholders and has paid or will pay registration fees; selling shareholders will bear selling commissions and similar expenses. The registration reflects the selling shareholders’ registration rights under a Purchase Agreement and permits resale by those holders or their permitted transferees in various transaction types described in the Plan of Distribution.
Abivax SA has scheduled its annual ordinary and extraordinary general meeting for May 11, 2026, at 3:00 pm CEST in Paris. The company states that the agenda, draft resolutions and details on how to attend and vote were published in the French official legal bulletin on April 3, 2026. Preparatory documents required under French law are available to shareholders through the company’s website. This report and the attached press release are also incorporated by reference into Abivax’s existing Form F-3 and Form S-8 registration statements in the United States.
Abivax SA, a French clinical-stage biopharma listed via ADSs on the Nasdaq Global Market, reports continued heavy losses and remains pre-revenue. For the year ended December 31, 2025, net loss widened to €336.1 million, following losses of €176.2 million in 2024 and €147.7 million in 2023.
The company is highly dependent on its lead candidate obefazimod for inflammatory bowel diseases, with all other programs at earlier stages and no approved products. Abivax carried forward €912.9 million of tax losses as of December 31 2025 and booked a €3.1 million French R&D tax credit that year.
Material weaknesses in internal control over financial reporting identified in prior years persisted through 2025 across risk assessment, control activities, information and communication, monitoring and control environment, despite ongoing remediation. Potential dilution is significant: 8,857,084 potential new ordinary shares from equity instruments outstanding at December 31 2025, equal to a hypothetical 11.3% dilution, while equity incentive plans represented 9.2% of fully diluted share capital. Ordinary shares outstanding totaled 78,536,412 at year-end 2025.
Abivax reported audited full-year 2025 results, combining a large capital raise with heavier investment and losses as it advances obefazimod toward late-stage milestones. The company completed a U.S. underwritten public offering raising net proceeds of approximately $700.3 million, or about €597.2 million.
Cash, cash equivalents and short-term investments reached €530.4 million as of December 31, 2025, supporting a projected cash runway into Q4 2027. Abivax settled substantially all debt with Kreos, Claret and Heights, sharply reducing borrowings to €1.9 million while increasing royalty certificate liabilities to €30.2 million.
R&D expenses rose to €177.8 million, mainly from Phase 3 ulcerative colitis and Phase 2b Crohn’s disease trials for obefazimod and related CMC and new indication work. G&A expenses more than doubled to €67.7 million, driven largely by share-based compensation and related employer taxes. Net loss widened to €336.1 million.
A March 18, 2026 DSMB review of the ABTECT-UC Phase 3 maintenance trial reported no new safety signals, with nearly 90% of patients completing 44 weeks, and topline results remain expected in late Q2 2026. Abivax strengthened its leadership bench with a new Chief Commercial Officer and senior regulatory and research hires, while its Chief Scientific Officer departs after 17 years.
Abivax SA filed a Form 6-K summarizing extensive new data on its lead candidate obefazimod in inflammatory bowel disease, including 22 abstracts presented at ECCO 2026. Preclinical models showed first evidence of anti-fibrotic activity, with large reductions in fibrosis and inflammation markers under early and late treatment.
A pooled safety analysis from the Phase 3 ABTECT induction trials reported serious treatment emergent adverse event and discontinuation rates similar to placebo across 1,272 patients, with mostly mild, short-lived headaches. Clinical data showed symptomatic response from week 1 and symptomatic remission from week 2, alongside increased miR-124 expression and reduced IL-17A and IL-6 levels. The company highlighted upcoming Phase 3 maintenance trial results expected in Q2 2026 and Phase 2b ENHANCE-CD trial results expected in Q4 2026.
Abivax S.A. received an updated ownership report from Invus Public Equities and related entities, which together may be deemed to beneficially own 3,922,995 Ordinary Shares as of December 31, 2025. This stake represents 5.0% of Abivax’s ordinary shares, based on 77,830,067 shares outstanding as of September 30, 2025.
The filing explains the control chain: Invus Public Equities directly holds the shares, with Invus Public Equities Advisors, Invus Global Management, Siren, L.L.C., and individual Raymond Debbane each potentially deemed beneficial owners through their respective roles. The report notes that the CUSIP 00370M103 applies to Abivax American Depositary Shares, each representing one Ordinary Share.
The reporting persons certify that the securities were not acquired and are not held for the purpose of changing or influencing control of Abivax, but as a passive investment under the applicable SEC rules.
Abivax S.A. shareholder Sofinnova Crossover I SLP and affiliated reporting persons update their ownership after selling American depositary shares in the market. On January 12 and 13, 2026, Sofinnova Crossover I SLP sold multiple blocks of Abivax ADSs in open‑market transactions at weighted average prices ranging from $118.27 to $141.26 per ADS, plus a separate trade of 100 ADS at $142.00 per ADS.
As of January 14, 2026, Sofinnova Crossover I SLP holds 3,334,739 Ordinary Shares, representing about 4.3% of Abivax’s 78,398,795 Ordinary Shares outstanding as of November 30, 2025. These shares carry 6,399,478 voting rights, or 7.7% of the 82,688,932 voting rights outstanding. The management company Sofinnova Partners SAS and investment committee members may be deemed to share voting and investment control, although the individuals disclaim beneficial ownership except for their pecuniary interests.
ABVX shareholder Sofinnova Crossover I SLP has filed a notice of proposed sale under Rule 144 covering 1,000,000 ADS, to be sold through Leerink Partners on the NASDAQ. The filing lists an aggregate market value of 133700000.00 for these shares and an approximate sale date of 01/08/2026.
The ADS were originally acquired in a private placement from the issuer on 07/11/2019, with cash payment completed on 07/15/2019. The filing also notes that securities of the same issuer were sold in the prior three months: 590,877 ADS on 10/28/2025 for gross proceeds of 55638897.00, and 609,123 ADS on 10/29/2025 for gross proceeds of 57261354.00. Shares outstanding are shown as 77,800,000 ADS, providing context for the size of the planned sale.