Abivax Provides 2026 Corporate Outlook
Rhea-AI Summary
Abivax (NASDAQ:ABVX) provided its 2026 corporate outlook, highlighting progress for obefazimod in ulcerative colitis (UC) and Crohn’s disease (CD), market research projecting worldwide UC sales rising from $9.2B in 2025 to $21.2B by 2032, and DSMB safety review of ABTECT showing no new safety signals with >80% of participants completing the 44-week maintenance phase.
Topline ABTECT-UC maintenance results are expected late Q2 2026 with a planned US filing in late 2026. ENHANCE-CD induction results are expected late 2026. Cash runway is projected into Q4 2027 after full debt repayment in Q4 2025. Twenty-two abstracts will be presented at ECCO Feb 18-21, 2026.
Positive
- No new safety signals reported by DSMB with >80% completion of 44-week maintenance
- Topline ABTECT-UC maintenance results expected in late Q2 2026
- Planned US regulatory filing for obefazimod in late 2026
- Cash runway projected into Q4 2027 after debt repayment in Q4 2025
- ENHANCE-CD Phase 2b induction results expected in late 2026
Negative
- None.
News Market Reaction
On the day this news was published, ABVX gained 6.20%, reflecting a notable positive market reaction. Argus tracked a peak move of +4.5% during that session. Argus tracked a trough of -11.2% from its starting point during tracking. Our momentum scanner triggered 42 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $589M to the company's valuation, bringing the market cap to $10.08B at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ABVX fell 3.35% while close peers showed mixed moves (e.g., CYTK up 5.75%, LEGN up 3.3%, RYTM down 1.81%, AXSM down 0.65%). With no broad, same-direction move across peers and only one momentum peer (RVMD) down sharply, trading appears more company-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 18 | Index inclusion news | Positive | +2.5% | Nasdaq Biotechnology Index addition linked to successful ABTECT Phase 3 induction results. |
| Dec 17 | Conference abstracts | Positive | -0.1% | Announcement of 22 ECCO 2026 abstracts including anti‑fibrotic preclinical findings. |
| Dec 15 | Earnings and funding | Positive | -6.1% | Q3 2025 results with large July 2025 offering and cash runway into Q4 2027. |
| Nov 03 | Clinical PRO data | Positive | -3.5% | Phase 3 ABTECT induction PRO data showing improved quality of life measures. |
| Oct 06 | Clinical topline data | Positive | +3.3% | UEG presentation of pooled 8‑week ABTECT induction results with strong efficacy and safety. |
Positive clinical and corporate updates have produced mixed reactions, with several instances of share price declines following constructive news.
Over the past few months, Abivax has reported multiple clinical and corporate milestones tied to obefazimod. Inclusion in the Nasdaq Biotechnology Index on Dec 22, 2025 and late‑breaking Phase 3 ABTECT induction data both saw modest positive price reactions. However, earnings on Dec 15, 2025 and favorable patient‑reported outcomes on Nov 3, 2025 coincided with notable declines. Today’s 2026 outlook, emphasizing UC market expansion, Phase 3 maintenance progress, and cash runway into Q4 2027, fits into this pattern of fundamentally positive messaging against uneven short‑term price responses.
Market Pulse Summary
The stock moved +6.2% in the session following this news. A strong positive reaction aligns with the stock’s pre‑news uptrend, with ABVX trading above its $58.68 200‑day moving average and far above its $4.77 52‑week low. The outlook reinforces a sizeable UC market opportunity, advancing Phase 3 maintenance and Phase 2b Crohn’s programs, and a cash runway into Q4 2027. Investors have previously shown selective enthusiasm for positive updates, so sustainability would depend on delivering the expected late Q2 2026 maintenance topline and the planned late 2026 NDA filing.
Key Terms
phase 3 medical
phase 2b medical
dsmb medical
nda regulatory
induction trial medical
maintenance trial medical
pde-4 medical
il-23 medical
AI-generated analysis. Not financial advice.
Abivax Provides 2026 Corporate Outlook
- New market insights indicate significant future expansion of the ulcerative colitis (UC) market, with obefazimod well positioned to become a future market leader in the IBD space
- ABTECT Phase 3 Data Safety Monitoring Board (DSMB) meeting on December 18, 2025, found no new safety signals with over
80% of participants having completed the 44-week double blind maintenance trial - ABTECT-UC Phase 3 maintenance topline results expected late Q2 2026, with a subsequent US regulatory filing planned for late 2026
- ENHANCE-CD Phase 2b induction trial of obefazimod in moderate-to-severely active Crohn’s disease (CD) ongoing; induction results expected late 2026
- 22 abstracts accepted for upcoming February 2026 European Crohn’s and Colitis Organization (ECCO) conference including oral presentation of obefazimod impact on fibrosis in in-vitro and preclinical models
- Cash runway expected into Q4 2027, after full debt reimbursement in Q4 2025
PARIS, France – January 7, 2026 – 10:05 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced its 2026 corporate outlook, highlighting new market insights, progress in the ABTECT-UC and ENHANCE-CD trials, and advances in its therapeutic pipeline. Updates from the ABTECT Phase 3 maintenance trial evaluating obefazimod for the treatment of moderate-to-severely active UC reinforce the therapy’s safety profile and inform potential future combination strategies.
Marc de Garidel, MBA, Chief Executive Officer of Abivax, commented: “As I reflect on our advances in 2025, I am beyond thankful for the patients and physicians who have helped advance our trials and for the Abivax employees and investors who supported this progress. This past year was a monumental one for Abivax as we announced positive data from our ABTECT Phase 3 8-week induction trial demonstrating obefazimod’s safety and potential as a first-in-class oral therapy for UC, we shared updates at major international meetings, and we closed a successful significant fundraising round. In 2026, I look forward to continuing this momentum as we evaluate the ABTECT-UC Phase 3 maintenance and ENHANCE-CD Phase 2 induction data and identify new opportunities for advancement of our pipeline. The findings shared today from the updated market research and DSMB safety analyses demonstrate the significant opportunity we have for making a real impact for the millions of patients inadequately addressed by current treatment options.”
LOOKING AHEAD TO 2026:
Ulcerative Colitis Market Opportunity
Multiple third-party industry analyses forecast significant growth in the ulcerative colitis (UC) market over the coming years, driven by increased use of advanced therapies and the launch of innovative mechanisms of action (MOAs). In one recently published report, worldwide UC sales are expected to more than double, increasing from
In this context, market research following the announcement of the ABTECT Phase 3 induction results in July 2025 indicates that obefazimod may emerge as the future market leader in UC, potentially outperforming both currently approved therapies and anticipated future entrants, including TL1A inhibitors and oral IL-23 agents.
The research estimated that roughly 500K patients within the United States are currently on conventional therapies (5ASA’s/corticosteroids), with approximately
ABTECT Phase 3 DSMB Update, Maintenance Topline Results, and Expected US Filing Timing
The ABTECT Phase 3 DSMB meeting occurred on December 18, 2025, and reported no new safety signals with over
Topline results from the ongoing ABTECT Phase 3 maintenance trial are expected in late Q2 2026 which has the potential to further demonstrate the durability of obefazimod treatment in UC and extended duration of therapy versus the currently available treatment options.
Ongoing New Drug Application (NDA) preparation includes planned engagement with the FDA in anticipation of planned filing in late 2026.
Pipeline Advancement
Obefazimod has a first-in-class mechanism of action that targets the site of inflammation and, together with preclinical evidence of a clear anti-fibrotic effect in Crohn’s disease, underscores its potential as a differentiated treatment option for patients with the condition. Detailed results, including 22 abstracts, will be shared at the 2026 European Crohn’s and Colitis Organization (ECCO) Annual Meeting taking place in Stockholm, Sweden on February 18-21, 2026.
The ENHANCE-CD Phase 2b, designed to evaluate the safety and efficacy of obefazimod in patients with moderate-to-severely active Crohn’s disease (CD), is actively progressing. The 12-week induction trial results are anticipated in late 2026 and will help inform the design of subsequent registrational studies.
Throughout 2026, initial preclinical results from ongoing studies evaluating obefazimod in combination with other agents (currently targeted combination MOAs include IL-23, a4b7, PDE-4 and AhR) will be shared, with a lead combination candidate selected to advance into development by year-end.
The company is also continuing to evaluate follow-on miR-124 enhancers in various chronic inflammatory models to further extend the mechanistic framework established with obefazimod. In parallel, the team is evaluating potential in-licensing opportunities for innovative, mechanistically complementary assets in inflammatory bowel disease to strengthen its portfolio.
Marc de Garidel continued: “This past year we have worked diligently to advance obefazimod in both ulcerative colitis and Crohn’s disease, showcasing the immense opportunity we have in expanding the current market and the potential for movement into first- and second-line therapy options. With our recently secured funding poised to support us into Q4 2027, we are now focused on completing our ABTECT Phase 3 maintenance trial to support potential NDA filing by the end of the year, completing our Phase 2b Crohn’s disease trial, and evaluating additional opportunities for advancement across our pipeline. We look forward to sharing additional updates throughout the year as we aim to offer a safer, more effective and durable treatment option for those impacted by chronic inflammatory diseases like UC and Crohn’s.”
Abivax 2026 Financial Reporting Calendar
March 23, 2026: Fiscal Year 2025 Financial Results
June 1, 2026: Q1 2026 Financial Results
June 5, 2026: Annual General Meeting / Extraordinary General Meeting
September 14, 2026: H1 2026 Financial Results
December 14, 2026: Q3 2026 Financial Results
About Abivax
Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis.
| Contact: Patrick Malloy SVP, Investor Relations Abivax SA patrick.malloy@abivax.com +1 847 987 4878 | Media Contacts: LifeSci Communications Karissa Cross, Ph.D. Associate Director kcross@lifescicomms.com |
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s expectations for 2026, including the Company’s anticipated timing for topline results of its ABTECT Phase 3 maintenance and timing of the Company’s planned NDA filing, results of its ENHANCE-CD Phase 2 induction clinical trials, the potential therapeutic benefit and market opportunity of obefazimod, planned announcement of combination therapy, progress of the Company’s follow-on compound and expected cash runway. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.
FAQ
When will Abivax (ABVX) report ABTECT-UC Phase 3 maintenance topline results in 2026?
What did the ABTECT DSMB conclude about obefazimod safety for ABVX on December 18, 2025?
When does Abivax plan to file a US regulatory application for obefazimod (ABVX)?
What is Abivax’s (ABVX) cash runway and key financing milestones for 2026?
When will results from the ENHANCE-CD Phase 2b induction trial for ABVX be available?
Will Abivax (ABVX) present new data at ECCO 2026 and what will be shown?
