Abivax SA
ABVX evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for ABVX—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ABVX
Abivax SA is a clinical-stage biopharmaceutical company focused on developing obefazimod, a drug candidate for ulcerative colitis and Crohn's disease, with no approved products or historical product revenues [sec · filed 2026-03-23].
Key risk: No approved products or revenues
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Dec 31, 2025.
Tracking 17 clinical trials · 1 catalyst for Abivax SA.
Abivax SA is a clinical-stage biopharmaceutical company focused on developing obefazimod, a drug candidate for ulcerative colitis and Crohn's disease, with no approved products or historical product revenues [sec · filed 2026-03-23].
- Abivax is a clinical-stage company with no approved products and no historical product revenues, making its future prospects difficult to assess [sec · filed 2026-03-23].
- As of 2025-12-31, the company reported cash & equivalents of $38.1M, net income of -$82.0M, shareholders' equity of $196.0M, and total debt of $66.1M [sec].
- The company expects to fund its forecasted cash flow requirements into the fourth quarter of 2027, allowing 12 months of cash runway post planned NDA submission for UC, assuming positive Phase 3 results [sec · filed 2025-12-15].
- Abivax has incurred considerable losses historically and expects to continue incurring significant operating losses for the foreseeable future [sec · filed 2026-03-23].
What works
- The company has a clear development pathway for obefazimod in ulcerative colitis, with a planned NDA submission in the second half of 2026 [sec · filed 2025-12-15].
- Cash runway is projected into Q4 2027, providing a buffer to reach key milestones such as NDA submission [sec · filed 2025-12-15].
- Abivax has secured funding through multiple sources, including equity offerings, bank borrowings, and subsidies from Bpifrance [sec · filed 2025-06-02].
What to weigh
- The company has no approved products and no historical product revenues, making it entirely dependent on clinical success [sec · filed 2026-03-23].
- Abivax has incurred considerable losses historically and expects to continue incurring significant operating losses for the foreseeable future [sec · filed 2026-03-23].
- The company's ability to achieve profitability is contingent on obtaining regulatory approvals and commercializing obefazimod, which is uncertain [sec · filed 2026-03-23].
- Investment in biopharmaceutical product development is highly speculative, with substantial risk of failure at any stage [sec · filed 2026-03-23].
From the filings
Quoted directly from source documents.
The company is a clinical-stage company with no approved products and no historical product revenues.
“We are a clinical-stage company with a limited operating history and no approved products and no historical product revenues, which makes it difficult to assess our future prospects and financial results.”
SEC filings · March 23, 2026
The company expects to fund operations into Q4 2027, with 12 months of cash runway post NDA submission.
“Based on the Group's existing cash and cash equivalents of € 589.7 million as of September 30, 2025, the Group expects, as of the date of issuance of these financial statements, to be able to fund its forecasted cash flow requirements into the fourth quarter of 2027, allowing it to reach 12 months of expected cash runway following the planned NDA submission for UC in the second half of 2026, assuming positive results from its Phase 3 maintenance trial.”
SEC filings · December 15, 2025
The company has incurred considerable losses historically and expects to continue.
“We have incurred considerable losses historically, which we anticipate will continue”
SEC filings · March 23, 2026
Catalyst timeline
- 2030-05-01 · Phase3_Topline — Topline results from the Phase 3 maintenance trial of obefazimod in ulcerative colitis will be a key determinant for NDA submission and future funding.
Risks & what to watch (4)›
Key risks
- No approved products or revenues — The company has no approved products and no historical product revenues, making it entirely dependent on clinical success [sec · filed 2026-03-23].
- Continued operating losses — Abivax has incurred considerable losses historically and expects to continue incurring significant operating losses for the foreseeable future [sec · filed 2026-03-23].
- Clinical trial and regulatory risk — The company's drug candidate obefazimod may fail to demonstrate adequate efficacy or safety, or gain regulatory approval [sec · filed 2026-03-23].
- Dependence on additional capital — The company may need additional funding to complete development and commercialization, and such funding may not be available [sec · filed 2026-03-23].
What to watch
- Phase 3 topline data for obefazimod in ulcerative colitis, expected around 2030-05-01 [catalyst_timeline].
- Planned NDA submission for UC in the second half of 2026, contingent on positive Phase 3 results [sec · filed 2025-12-15].
- Cash runway updates, as the company expects to fund operations into Q4 2027 [sec · filed 2025-12-15].
Sources: SEC filings · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
24.8 months
D/E 0.28
No tracked pipeline phase
No tracked pipeline candidates
1 upcoming, next in ~1340d
No insider transactions in the last 180 days
Runway
Catalysts
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
247
Total value held
$4.04B
| Holder | Shares | Value |
|---|---|---|
| janus henderson group plc | 1,757,658 | $196.0M |
| morgan stanley | 1,704,958 | $189.8M |
| caligan partners lp | 1,461,924 | $162.8M |
| adar1 capital management, llc | 1,438,019 | $160.1M |
| citadel advisors llc | 1,339,038 | $149.1M |
| westfield capital management co lp | 1,322,938 | $147.3M |
| fmr llc | 1,286,373 | $143.2M |
| susquehanna international group, llp | 1,284,782 | $143.1M |
| eversept partners, lp | 934,423 | $104.0M |
| baker bros. advisors lp | 875,796 | $97.5M |
Showing top 10 of 247 institutional holders of Abivax SA. Open the full 13F history after sign-in.
Short Interest
as of Apr 24, 2026- % of float
- 4.2%
- Days to cover
- 3.0
- Shares short
- 3,266,931
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ABVX short interestGovernance
Frequently asked questions
What is the AI investment thesis for Abivax SA?
Abivax SA is a clinical-stage biopharmaceutical company focused on developing obefazimod, a drug candidate for ulcerative colitis and Crohn's disease, with no approved products or historical product revenues [sec · filed 2026-03-23].
What is Abivax SA's next catalyst?
Abivax SA's next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safet" — expected May 1, 2030.
Who is the CEO of Abivax SA?
Mr. Marc M. P. de Garidel M.B.A. is the chief executive officer of Abivax SA (ABVX).
Where is Abivax SA headquartered?
Abivax SA (ABVX) is headquartered in Paris, France.
What therapeutic areas does Abivax SA focus on?
Abivax SA develops therapies across Oncology, Immunology, Infectious Disease, Respiratory, Musculoskeletal.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.