Welcome to our dedicated page for Abivax S.A. SEC filings (Ticker: ABVX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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.
Abivax SA is reported to have significant ownership by TCG Crossover investment entities and Chen Yu through American Depositary Shares (ADSs), each representing one ordinary share. TCG Crossover Fund I, L.P. and its general partner TCG Crossover GP I, LLC report beneficial ownership of 4,924,377 ADSs, or 5.7% of Abivax’s ordinary shares outstanding. TCG Crossover Fund II, L.P. and TCG Crossover GP II, LLC report 1,083,457 ADSs, or 1.3%. Chen Yu, as sole managing member of both general partners, may be deemed to share voting and dispositive power over an aggregate 6,007,834 ADSs, representing 7.0% of the class, based on 86,094,535 shares outstanding as of July 2, 2026, following an underwritten offering. The reporting parties collectively disclaim group status and beneficial ownership beyond their pecuniary interests.
Abivax S.A. has a significant shareholder group led by Invus Public Equities, L.P. and affiliated entities, which collectively report beneficial ownership of approximately 6.0% of Abivax’s Ordinary Shares as of June 30, 2026. This ownership is held through a combination of Ordinary Shares and American Depositary Shares.
Invus Public Equities beneficially holds 4,790,187 Shares, represented by 4,249,759 Ordinary Shares and 540,428 ADSs, while Avicenna Life Sci Master Fund LP holds 35,572 ADSs, with each ADS representing one Ordinary Share. Based on 79,800,669 Shares outstanding as of June 26, 2026, each reporting person is shown with 6.0% beneficial ownership. The reporting group certifies that the securities are held without the purpose or effect of changing or influencing control of Abivax S.A.
Sofinnova Crossover I SLP and related parties filed Amendment No. 6 to their Schedule 13D on Abivax S.A. after a series of open‑market sales of American depositary shares (ADSs) and ordinary shares on NASDAQ and Euronext.
Between June 30 and July 6, 2026, Sofinnova sold blocks of ADSs and ordinary shares at weighted average prices mostly above $130 per share. Following these transactions, Sofinnova held 2,474,299 ordinary shares, representing about 3.1% of Abivax’s outstanding ordinary shares, and 3,535,843 voting rights, or about 4.3% of outstanding voting rights as of May 31, 2026.
The filing emphasizes that Sofinnova acquired its position for investment purposes but may buy or sell additional Abivax securities over time, and that individual investment committee members disclaim beneficial ownership beyond their economic interest.
Abivax entered into an underwriting agreement for a public offering of 6,400,000 American Depositary Shares, each representing one ordinary share, at $125.00 per ADS. The company expects net proceeds of about $759.8 million (€666.8 million) after underwriting discounts and estimated expenses. The offering is a takedown from Abivax's automatic shelf registration statement on Form F-3 and is expected to close on July 6, 2026, subject to customary closing conditions.
Abivax SA is conducting a public offering of 6,400,000 ADSs at $125.00 per ADS. The offering price implies gross proceeds of $800,000,000 before underwriting discounts; proceeds to the company before expenses are $762,000,000. The underwriters have a 30-day option to purchase up to 960,000 additional ADSs.
The company recently repurchased royalty certificates for aggregate consideration of $90.0 million, funded half in cash and half by issuing 403,347 ordinary shares (including ADSs). Abivax reported positive topline Phase 3 maintenance results for obefazimod in ulcerative colitis, with higher response and remission rates at the 50 mg dose in exploratory cohorts and safety findings summarized across treatment arms.
Abivax SA is offering up to $600,000,000 of American Depositary Shares (ADSs), each representing one ordinary share. The ADSs trade on Nasdaq under the symbol ABVX and the ordinary shares trade on Euronext Paris under ABVX. The prospectus supplement describes offering mechanics, underwriting arrangements and customary lock-ups, and registers resale of ADSs issued in a prior private placement in connection with a $90.0 million royalty certificate repurchase (403,347 ADSs issued).
The supplement also discloses positive topline results from Part 2 of the Phase 3 ABTECT 44‑week maintenance trial for obefazimod, including Week 44 clinical remission of 37.2% for the 50 mg arm (induction non-responders) and safety tables summarizing treatment-emergent adverse events and malignancy incidence metrics used for exposure‑adjusted comparisons.
Abivax SA filed a Post-Effective Amendment No. 1 to its Form F-3 to add debt securities under Rule 413(b) and replace its base prospectus. The amendment, dated June 30, 2026, becomes effective immediately upon filing and updates the prospectus to permit offerings of ordinary shares, ADSs, warrants and debt securities.
The prospectus states offerings may be made from time to time, either by the company or by selling security holders, in one or more transactions, and that specific terms will be provided in prospectus supplements. The document discloses recent market prices for ADSs and ordinary shares and summarizes governance, shareholder rights and distribution mechanics under French law.
Abivax reported positive topline results from ABTECT Maintenance Part 2, a Phase 3 trial of oral obefazimod in adults with moderately to severely active ulcerative colitis who were either induction non-responders or maintenance relapsers, a highly refractory population.
Among induction non-responders treated continuously with 50 mg obefazimod, Week 44 outcomes included clinical remission of 37.2%, clinical response of 61.5%, endoscopic improvement of 48.0%, Histologic-Endoscopic Mucosal Improvement of 44.6%, and endoscopic remission of 34.5%. In patients who relapsed during maintenance and were re-treated with 50 mg, clinical response rates reached 69.7% and 66.7%, with clinical remission around 45% in both retreatment groups.
Part 2 meaningfully expanded long-term safety exposure. Four non-melanoma skin cancer events and two other malignancies were observed, largely in patients with established risk factors, with malignancy and NMSC exposure-adjusted incidence rates across Phase 2 and 3 falling within published ulcerative colitis background ranges. Abivax states it remains on track to submit a U.S. New Drug Application for obefazimod in ulcerative colitis in the fourth quarter of 2026.
Abivax reported positive Phase 3 ABTECT 44-week maintenance results for obefazimod, its once-daily oral miR-124 enhancer, in moderately to severely active ulcerative colitis. Among 580 induction responders, clinical remission at Week 44 reached 50.8% on 25 mg and 51.3% on 50 mg, versus 10.4% on placebo, with placebo-adjusted differences of 39.3% and 40.3% (p<0.0001 for both doses).
Both doses met all key secondary endpoints, including endoscopic improvement, endoscopic remission, HEMI, corticosteroid-free clinical remission and sustained clinical remission. Safety was generally favorable, with no deaths and similar rates of serious treatment-emergent adverse events to placebo. Abivax intends to submit a New Drug Application for obefazimod in ulcerative colitis in late fourth quarter 2026, while the ENHANCE-CD Phase 2b Crohn’s induction trial continues with topline data expected mid-2027.
Abivax reported a net loss of €48.5 million for the three months ended March 31, 2026, narrower than the €52.4 million loss a year earlier. Operating loss widened to €56.2 million as research and development spending rose 26% to €49.5 million, mainly for obefazimod clinical programs.
Financial income swung to a €8.0 million gain driven by foreign exchange gains and returns on invested IPO proceeds. Cash, cash equivalents and other short-term investments totaled €491.6 million, which management expects to fund operations into the fourth quarter of 2027.
After quarter-end, Abivax agreed to repurchase all outstanding royalty certificates for $90 million (about €76.5 million), paid half in cash and half via 403,347 new ADSs at $111.57. The certificates were cancelled, and the transaction is expected to generate an expense of about €43.0 million in the second quarter of 2026, alongside derecognition of a €6.1 million deferred tax liability.