Abivax SA
ABVX evidence brief
What we can confirm
- Market Cap:
- $9.91B
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 biotechnology company developing obefazimod, a first-in-class oral therapy for chronic inflammatory diseases, with positive Phase 3 results in ulcerative colitis and an NDA submission planned by end of 2026.
Key risk: Cash burn rate
Market Cap
$9.91B
Cash Runway
—
Lead Asset
—
Next Catalyst
—
Tracking 17 clinical trials for Abivax SA.
Abivax SA is a clinical-stage biotechnology company developing obefazimod, a first-in-class oral therapy for chronic inflammatory diseases, with positive Phase 3 results in ulcerative colitis and an NDA submission planned by end of 2026.
- Lead drug obefazimod delivered positive Phase 3 results in ulcerative colitis, meeting key secondary endpoints with a clean safety profile [news · 2026-02-04].
- Cash and cash equivalents were EUR 589.7 million as of September 30, 2025, with a cash runway into Q4 2027 [news · 2025-12-16].
- First-half 2026 operating cash use was €102.5 million, up from €66.6 million a year earlier; cash, equivalents and short-term investments totaled €402.4 million as of June 30, 2026 [news · 2026-09-26].
- Positive pre-NDA interaction with the FDA for obefazimod; NDA submission for ulcerative colitis remains on track by end of 2026 [news · 2026-07-30].
- Safety concerns regarding obefazimod have been largely addressed, with recent data easing cancer risk fears [news · 2026-09-23][news · 2026-06-30].
What works
- Positive Phase 3 results for obefazimod in ulcerative colitis, meeting key secondary endpoints with a clean safety profile [news · 2026-02-04].
- Extended funding runway through late 2027, providing capital to advance pivotal maintenance and Crohn’s trials without immediate new capital needs [news · 2026-02-04].
- Positive pre-NDA interaction with the FDA, keeping the company on track for an NDA submission by end of 2026 [news · 2026-07-30].
What to weigh
- Operating cash use increased 54% year-over-year to €102.5 million in first-half 2026, reflecting rising costs for advancing obefazimod and preparing for commercialization [news · 2026-09-26].
- Cash and cash equivalents declined from EUR 589.7 million (September 30, 2025) to €402.4 million (June 30, 2026), indicating significant cash burn [news · 2025-12-16][news · 2026-09-26].
- The company received a rating downgrade as it continues to develop obefazimod independently, without a partnership [news · 2026-03-25].
From the filings
Quoted directly from source documents.
Positive Phase 3 results for obefazimod in ulcerative colitis
“ABIVAX Société Anonyme recently reported that its lead drug candidate, obefazimod, delivered positive Phase 3 results in ulcerative colitis, meeting key secondary endpoints with a clean safety profile.”
News · February 4, 2026
Cash runway through late 2027
“Management also highlighted a solid funding runway through late 2027, giving the company room to advance pivotal maintenance and Crohn’s trials without immediate new capital needs.”
News · February 4, 2026
Cash and cash equivalents as of September 30, 2025
“Cash and cash equivalents of EUR 589.7 (as of September 30, 2025) with a cash runway into Q4 2027”
News · December 16, 2025
Positive pre-NDA interaction with FDA
“Company remains on track to submit its first New Drug Application for obefazimod for the treatment of moderately to severely active ulcerative colitis by the end of 2026”
News · July 30, 2026
Risks & what to watch (3)›
Key risks
- Cash burn rate — Operating cash use rose 54% to €102.5M in H1 2026; cash declined from €589.7M to €402.4M over nine months [news · 2026-09-26].
- Single-drug dependency — Abivax's pipeline is centered on obefazimod; any clinical or regulatory setback would severely impact the company [news · 2026-02-04].
- Independent commercialization — The company is advancing obefazimod alone, which increases financial and operational risk for launch [news · 2026-03-25].
What to watch
- NDA submission for obefazimod in ulcerative colitis by end of 2026 [news · 2026-07-30].
- Cash runway and burn rate updates, especially given the decline from EUR 589.7M to €402.4M [news · 2025-12-16][news · 2026-09-26].
- Pivotal maintenance and Crohn’s disease trial progress, which the current funding is intended to support [news · 2026-02-04].
- Any partnership or M&A developments, as the company is currently going it alone [news · 2026-03-25].
Sources: Catalysts · News · Generated October 12, 2026 · How we verify sources →
Run Abivax SA through your own thesis
Use the pipeline, catalyst, financial, FDA, and market facts on this page as inputs to a protocol you control.
Your protocol can:
- Turn available Abivax SA facts into screen rules or deeper checks
- Show cited findings, blockers, and unresolved evidence together
- Save the logic and rerun it as the company evidence changes
Evidence & data
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
252
Total value held
$5.38B
| Holder | Shares | Value |
|---|---|---|
| tcg crossover management, llc | 6,481,085 | $721.7M |
| ubs group ag | 4,547,406 | $506.4M |
| darwin global management, ltd. | 3,468,657 | $352.1M |
| morgan stanley | 1,704,958 | $189.8M |
| vestal point capital, lp | 1,500,000 | $167.0M |
| caligan partners lp | 1,461,924 | $162.8M |
| adar1 capital management, llc | 1,394,019 | $155.2M |
| westfield capital management co lp | 1,322,938 | $147.3M |
| fmr llc | 1,286,373 | $143.2M |
| helikon investments ltd | 1,013,324 | $112.8M |
Showing top 10 of 252 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 biotechnology company developing obefazimod, a first-in-class oral therapy for chronic inflammatory diseases, with positive Phase 3 results in ulcerative colitis and an NDA submission planned by end of 2026.
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.