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Abivax to Present Data on Obefazimod at Digestive Disease Week®

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Abivax (NASDAQ:ABVX) will present nine scientific abstracts on obefazimod at Digestive Disease Week, May 2–5, 2026, highlighting Phase 3 ABTECT efficacy, safety, patient-reported outcomes and preclinical anti-fibrotic models. Presentations include one oral session and multiple posters covering histologic, endoscopic, biomarker, and quality-of-life data.

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News Market Reaction – ABVX

-2.58%
-2.58% Session close to close

In the Apr 23 session, ABVX declined 2.58%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement emphasizes the breadth of obefazimod data, with 9 abstracts at DDW 2026 spanning e...
Analysis

This announcement emphasizes the breadth of obefazimod data, with 9 abstracts at DDW 2026 spanning efficacy, safety, quality-of-life and mechanistic anti-fibrotic findings from the Phase 3 ABTECT program. Combined with earlier Phase 3 results showing statistically significant remission benefits and extensive analyses at ECCO 2026, the news highlights continuing validation in ulcerative colitis. Investors may watch for full DDW readouts and upcoming ABTECT maintenance topline results expected in late Q2 2026.

Key Figures

Phase 3 endpoint ABTECT-1: 19.3% placebo-adjusted remission Phase 3 endpoint ABTECT-2: 13.4% placebo-adjusted remission DDW abstracts: 9 abstracts +5 more
8 metrics
Phase 3 endpoint ABTECT-1 19.3% placebo-adjusted remission Week 8 clinical remission; p<0.0001 in ABTECT-1
Phase 3 endpoint ABTECT-2 13.4% placebo-adjusted remission Week 8 clinical remission; p=0.0001 in ABTECT-2
DDW abstracts 9 abstracts Obefazimod data accepted for presentation at DDW 2026
R&D expenses €77.9M Six months ended Jun 30, 2025; up 21% vs prior year
Cash and equivalents €60.9M Balance at Jun 30, 2025 before large equity raise
Gross offering proceeds €637.5M Offering completed Jul 28, 2025; ≈$747.5M gross
Net offering proceeds €597.2M Estimated net proceeds from Jul 28, 2025 offering
Shareholders' equity €-48.3M Negative equity as of Jun 30, 2025

Historical Context

5 past events · Latest: Apr 01 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 01 Regulatory filings Neutral +3.0% Filed Universal Registration Document and Form 20-F with regulators.
Mar 23 Earnings and updates Neutral -4.5% Reported 2025 results, large cash balance and net loss with program updates.
Feb 21 Clinical data update Positive +2.0% Presented 22 ECCO abstracts with new efficacy, safety and biomarker data.
Jan 07 Corporate outlook Positive -8.7% Outlined 2026 outlook, timelines for UC and CD and extended cash runway.
Dec 18 Index inclusion Positive +1.2% Announced addition to Nasdaq Biotechnology Index tied to Phase 3 progress.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news, especially positive obefazimod and corporate updates, has more often led to aligned price reactions, with only one notable divergence on a broadly positive outlook update.

Recent Company History

Over the last six months, Abivax has progressed obefazimod and its capital position. The company secured inclusion in the Nasdaq Biotechnology Index on Dec 22, 2025 and later issued a 2026 corporate outlook emphasizing UC and CD progress and a cash runway into Q4 2027. Subsequent ECCO 2026 data showcased anti-fibrotic signals and reinforced Phase 3 efficacy and safety. Financial filings on Mar 23 and Apr 1, 2026 formalized 2025 results and regulatory reporting. Today’s DDW-focused announcement extends that same obefazimod data narrative into another major GI venue.

Key Terms

double-blind, placebo-controlled, ulcerative colitis, anti-fibrotic, +4 more
8 terms
double-blind medical
"phase 3, double-blind, placebo-controlled induction trials"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlled medical
"phase 3, double-blind, placebo-controlled induction trials"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
ulcerative colitis medical
"for the treatment of moderately to severely active ulcerative colitis (UC)"
A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.
anti-fibrotic medical
"preclinical anti-fibrotic activity in two preclinical fibrosis models"
Anti-fibrotic describes a drug or therapy that slows, stops, or reverses fibrosis—the buildup of scar tissue in organs (such as lungs, liver, or heart) that stiffens tissue and reduces function. For investors, anti-fibrotic treatments matter because they address chronic conditions with large unmet needs and potential long-term markets; like repairing a clogged pipe before it bursts, successful therapies can preserve organ function, affect patient outcomes, and drive regulatory, clinical and commercial value.
patient-reported outcomes medical
"efficacy, safety, and patient-reported outcomes, along with preclinical"
Reports provided directly by patients about their symptoms, daily functioning, and quality of life—collected through surveys, apps, or interviews—reflecting how a treatment affects real people rather than lab measures. Investors care because these firsthand accounts help regulators, doctors and payers judge a product’s real-world value and can influence approval, pricing, adoption and long-term sales; think of them as customer reviews that show whether a medical product truly improves everyday life.
clinical remission medical
"met the FDA primary endpoint of clinical remission at Week 8"
A state in which a patient’s disease symptoms have largely disappeared or dropped to a level so low they no longer interfere with daily life, as judged by doctors or trial measurements. For investors, reaching clinical remission in a drug trial or treatment program is like flipping a switch that shows the therapy can work — it boosts the odds of regulatory approval, broader use, and future sales, while still not guaranteeing a permanent cure.
miR-124 medical
"upregulation of miR-124, lowered IL-17A/IL-6, and comparable"
mir-124 is a tiny piece of genetic material called a microRNA that helps turn genes up or down, especially in brain and nerve cells; think of it as a thermostat that adjusts how much a gene produces. Investors care because changes in mir-124 levels can signal disease, be used as a diagnostic marker, or become a drug target—factors that can influence clinical trial results, regulatory decisions, and the commercial value of therapies.
cytokines medical
"reduces the key inflammatory cytokines IL-17A and IL-6 in serum"
Small proteins produced by immune and other cells that act as on/off signals or “text messages,” telling cells to ramp up, calm down, grow, or move during infection, injury, or disease. Investors watch cytokines because they are common drug targets and biomarkers—changes in cytokine activity can make a therapy work, cause serious side effects, or determine clinical trial and regulatory outcomes, all of which affect a company’s value.

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Abivax to Present Data on Obefazimod at Digestive Disease Week®

Presentations Highlight Comprehensive Efficacy, Safety, and Patient-Reported Outcomes from the Phase 3 ABTECT Program and Preclinical Anti-Fibrotic Models in Inflammatory Bowel Disease

PARIS, France – April 22, 2026 – 10:05 pm CESTAbivax 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 that nine scientific abstracts on obefazimod, its lead drug candidate for the treatment of moderately to severely active ulcerative colitis (UC), will be presented at the 2026 Digestive Disease Week (DDW) taking place May 2-5, 2026 in Chicago, IL. These presentations will highlight data from the Phase 3 ABTECT program, including efficacy, safety, and patient-reported outcomes, along with preclinical anti-fibrotic activity in two preclinical fibrosis models.

Fabio Cataldi, MD, Chief Medical Officer of Abivax, said: “The data being presented at this conference reinforce our confidence in obefazimod as a meaningful advancement for patients living with ulcerative colitis. From histologic and endoscopic outcomes to patient-reported improvements in fatigue and quality of life, these abstracts paint a comprehensive picture of a therapy with potential to address what matters most to patients and clinicians alike. We continue to be encouraged by the findings across the spectrum of disease severity and line of therapy."

Marc de Garidel, MBA, Chief Executive Officer of Abivax, added: “Our presence at DDW with nine abstracts highlights the depth and growing strength of the obefazimod dataset we are building in inflammatory bowel disease. These findings contribute to a more comprehensive understanding of its potential and support our ongoing efforts to bring meaningful innovation to patients.”

Visit the publications page of our website to view the presentations after the conclusion of the meeting.

Obefazimod Data to be Presented:

Date & Time SessionAbstract #TitlePresenter
Oral Presentation
Mon, May 4
10:00-10:15
Controlled Clinical Trials 14470489Impact of obefazimod treatment on histologic and combined histologic-endoscopic outcomes in patients with moderately to severely active UC: results from the ABTECT-1 and ABTECT-2 phase 3, double-blind, placebo-controlled induction trialsProf. Fernando Magro, MD, PhD

Head of the Department of Clinical Pharmacology and Professor of Pharmacology and Therapeutics at University Hospital São João in Porto, Portugal
Poster Presentation
Mon, May 4
12:30-1:30
Controlled Clinical Trials of IBD Treatment

Mo1513

Early symptomatic improvement with obefazimod in patients with moderately to severely active UC: pooled results from the ABTECT-1 and ABTECT-2 phase 3, double-blind, placebo-controlled induction trials

Prof. Marla Dubinsky, MD

Professor of Pediatrics and Medicine, Chief, Division of Pediatric Gastroenterology and Nutrition

Mon, May 4
12:30-1:30
Controlled Clinical Trials of IBD Treatment

Mo1533Efficacy and safety of obefazimod in an elderly population with moderately to severely active UC: week 8 results from the ABTECT-1 and ABTECT-2 phase 3, double-blind, placebo-controlled induction trials

Andres J Yarur, MD

Associate Professor of Medicine, Cedars-Sinai Medical Center
Mon, May 4
12:30-1:30
Controlled Clinical Trials of IBD Treatment

Mo1522

Efficacy of obefazimod in patients with moderately to severely active ulcerative colitis: results in subgroups of prior inadequate response to advanced therapy (AT-IR) including or excluding patients with prior JAK-IR from ABTECT phase 3 induction trials

Prof. Bruce E Sands, MD, MS

Professor of Medicine, Icahn School of Medicine at Mount Sinai

Mon, May 4
12:30-1:30

Controlled Clinical Trials of IBD Treatment

Mo1525Integrated summary of safety of obefazimod in phase 3 ABTECT induction trials

Prof. Bruce E Sands, MD, MS

Professor of Medicine, Icahn School of Medicine at Mount Sinai

Mon, May 4
12:30-1:30

Quality of Life and Psychosocial OutcomesMo1677

Improvements in patient-reported fatigue among patients with moderately to severely active UC treated with obefazimod: pooled results from the 8-week ABTECT-1 and ABTECT-2 phase 3 double-blind, placebo-controlled induction trials

Prof. Marla Dubinsky, MD

Professor of Pediatrics and Medicine, Chief, Division of Pediatric Gastroenterology and Nutrition

Mon, May 4
12:30-1:30

Quality of Life and Psychosocial OutcomesMo1667

Improvements in patient-reported, disease-specific and overall quality-of-life among patients with moderately to severely active UC treated with obefazimod: pooled results from the 8-week ABTECT-1 and ABTECT-2 phase 3 induction trials

Prof. Bruce E Sands, MD, MS

Professor of Medicine, Icahn School of Medicine at Mount Sinai
Tue, May 5
12:30-1:30

Mechanisms of IBD Therapeutics

Tu1433

Obefazimod shows first evidence of dual anti-inflammatory and anti-fibrotic activity in murine in vivo and human in vitro models

Prof. Silvio Danese, MD, PhD

Director of Gastroenterology and Gastrointestinal Endoscopy Unit at IRCCS San. Raffaele Hospital

Tue, May 5
12:30-1:30

Mechanisms of IBD TherapeuticsTu1449Obefazimod enhances mir-124 expression in blood and colon tissue and reduces the key inflammatory cytokines IL-17A and
IL-6 in serum of patients with moderate-to-severely active UC: results from the phase 3 ABTECT induction trials
Parambir S Dulai, MD

Associate Professor, Feinberg School of Medicine at Northwestern University


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 Contact:
LifeSci Communications
Karissa Baltz, Ph.D.
Associate Director
LSC_ABIVAX@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,” “on track,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the potential therapeutic benefit of obefazimod and other statements that are not historical fact. 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 for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission on March 23, 2026 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.

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FAQ

What obefazimod data will Abivax (ABVX) present at DDW 2026?

Abivax will present nine abstracts covering Phase 3 ABTECT efficacy, safety, patient-reported outcomes, and preclinical anti-fibrotic models. According to the company, sessions include an oral presentation and multiple posters between May 4–5, 2026, spanning histologic, endoscopic, biomarker, and quality-of-life endpoints.

When and where is the oral presentation on obefazimod at DDW 2026?

The oral presentation is scheduled for May 4, 2026, 10:00–10:15 AM during the Controlled Clinical Trials 1 session. According to the company, Prof. Fernando Magro will present histologic and combined histologic-endoscopic outcomes from ABTECT-1 and ABTECT-2.

Which patient-reported outcomes for obefazimod are included in the ABTECT abstracts (ABVX)?

The abstracts include pooled results on patient-reported fatigue and disease-specific and overall quality-of-life from the 8-week ABTECT induction trials. According to the company, these posters report symptomatic and quality-of-life improvements alongside clinical and endoscopic measures.

Does Abivax (ABVX) present safety data for obefazimod at DDW 2026?

Yes, an integrated safety summary from the Phase 3 ABTECT induction trials is being presented as a poster. According to the company, that poster consolidates safety findings from ABTECT-1 and ABTECT-2 to inform tolerability in moderately to severely active ulcerative colitis.

What preclinical anti-fibrotic evidence for obefazimod will be shown at DDW 2026?

Presentations include evidence of dual anti-inflammatory and anti-fibrotic activity in murine in vivo and human in vitro models. According to the company, these preclinical abstracts describe activity in two fibrosis models and mechanistic biomarker changes linked to mir-124 and cytokine reduction.