Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis

Rhea-AI Summary

Abivax (Nasdaq:ABVX) reported topline Phase 3 ABTECT maintenance results for oral obefazimod in moderately to severely active ulcerative colitis.

At Week 44, clinical remission was 50.8% (25 mg) and 51.3% (50 mg) versus 10.4% placebo; all key secondary endpoints were met and safety was favorable. An NDA filing for UC is planned for Q4 2026, with Phase 2b Crohn’s induction topline data expected mid-2027.

Positive

• Week 44 clinical remission 50.8% and 51.3% vs 10.4% placebo
• All key secondary ulcerative colitis endpoints met at both doses
• Placebo-adjusted remission differences of 39.3% and 40.3%; p<0.0001
• No new safety signals over 44 weeks; no treatment-related deaths
• Sustained remission 67.1% and 65.6% vs 15.7% placebo subgroup
• NDA for ulcerative colitis planned in late Q4 2026

Negative

• Any TEAEs higher with 50 mg (71.8%) vs placebo (50.0%)
• Malignancies and non-melanoma skin cancers reported among treated patients
• Obefazimod remains investigational; regulatory approval not yet obtained

News Market Reaction – ABVX

-44.10% 10.1x vol

131 alerts

-44.10% Session close to close

+2.8% Peak Tracked

-60.6% Trough Tracked

$10.28B Market Cap

10.1x Rel. Volume

In the Jun 2 session, ABVX declined 44.10%, reflecting a significant negative market reaction. Argus tracked a peak move of +2.8% during that session. Argus tracked a trough of -60.6% from its starting point during tracking. Our momentum scanner triggered 131 alerts that day, indicating very high trading interest and price volatility. Trading volume was exceptionally heavy at 10.1x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -44.1% in the session following this news. A negative reaction despite robust Phas...

Analysis

The stock dropped -44.1% in the session following this news. A negative reaction despite robust Phase 3 maintenance efficacy would fit a pattern where some positive clinical updates, such as PRO data in Nov 2025, saw limited or negative moves. Past dilution and financing steps, including securities offerings, have also influenced trading separate from trial success. In that context, attention often turns to balance-sheet developments, future trial costs, and the timeline to the planned Q4 2026 NDA submission.

Key Figures

Clinical remission 25 mg: 98/193 (50.8%) Clinical remission 50 mg: 100/195 (51.3%) Placebo-adjusted remission: ∆39.3% (25 mg), ∆40.3% (50 mg) +5 more

8 metrics

Clinical remission 25 mg 98/193 (50.8%) Week 44 Phase 3 ABTECT maintenance; placebo 20/192 (10.4%)

Clinical remission 50 mg 100/195 (51.3%) Week 44 Phase 3 ABTECT maintenance; placebo 20/192 (10.4%)

Placebo-adjusted remission ∆39.3% (25 mg), ∆40.3% (50 mg) FDA primary endpoint at Week 44; p<0.0001 for both doses

Maintenance trial size N=580 Phase 3 ABTECT 44-week maintenance, responders re-randomized

Sustained remission 25 mg 49/73 (67.1%) Week 44 sustained clinical remission vs placebo 8/51 (15.7%)

Any TEAE 50.0% placebo, 58.0% (25 mg), 71.8% (50 mg) Treatment-emergent adverse events over 44 weeks

Serious TEAEs 4.2% placebo, 2.6% (25 mg), 5.6% (50 mg) Serious treatment-emergent adverse events; no deaths reported

NDA timing Late Q4 2026 Planned New Drug Application submission for UC to the FDA

Previous Clinical trial Reports

5 past events · Latest: Nov 03 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Nov 03	PRO data update	Positive	-0.2%	Phase 3 induction PRO results showing improved quality of life metrics.
Sep 29	Conference abstracts	Positive	+1.9%	Acceptance of additional late-breaking ABTECT induction abstracts at UEG 2025.
Sep 23	Upcoming presentation	Neutral	+0.7%	Announcement of upcoming late-breaking ABTECT Phase 3 induction presentation.
Jul 22	Phase 3 induction win	Positive	+586.0%	Positive Phase 3 ABTECT induction results with strong remission and safety.
Apr 29	Trial enrollment complete	Positive	+0.0%	Completion of Phase 3 ABTECT enrollment with slightly above-target patients.

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

Pattern Detected

Clinical trial news for obefazimod has often been a strong driver, with past Phase 3 induction results linked to a +586% move and an average same-tag move of 117.66%. More incremental clinical updates have seen muted or even slightly negative reactions, indicating the market distinguishes between major efficacy milestones and secondary or conference-related data.

Recent Company History

Over the past year, Abivax has progressed obefazimod through key Phase 3 milestones in ulcerative colitis. Enrollment completion in Apr 2025 led into positive 8-week induction results in Jul 2025, which drove a +586% move. Subsequent UEG late-breaking abstracts and PRO data in Sep–Nov 2025 provided supportive but more incremental validation with modest price impacts. Today’s 44-week maintenance data complete the Phase 3 efficacy story, aligning with the previously signaled plan to file an NDA in Q4 2026.

Key Terms

new drug application, fda, phase 3, randomized, double-blind, placebo-controlled, +3 more

7 terms

new drug application regulatory

"The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

fda regulatory

"submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

phase 3 medical

"announced positive topline results from the Phase 3 ABTECT maintenance trial evaluating obefazimod"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized, double-blind, placebo-controlled medical

"global 44-week multicenter, randomized, double-blind, placebo-controlled trial that evaluated"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

mantel-haenszel technical

"based on estimated common risk difference using the Mantel-Haenszel weights adjusting"

A Mantel–Haenszel method is a statistical way to combine results from several similar groups or studies while accounting for differences between them, producing a single adjusted measure of an effect (for example, how much a treatment changes outcomes). For investors, it matters because regulators and researchers often use this technique to judge whether a medical treatment or safety signal is truly consistent across patient groups — like averaging test results from several classrooms while correcting for different class sizes.

treatment-emergent adverse events medical

"TEAEs 2 , n (%) | Placebo (N=192) | 25 mg (N=193) | 50 mg (N=195) Any TEAE"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

opportunistic infections medical

"Serious/severe (grade≥3) infections and opportunistic infections 3 | 2 (1.0%)"

Infections that occur when bacteria, viruses, fungi or other microbes take advantage of a weakened immune system and cause illness that they normally would not in healthy people. Investors watch these because their appearance in clinical trials, patient populations or product use can signal safety risks, affect regulatory reviews, increase treatment costs or reduce market demand—like discovering mold in a house that lowers its value and increases repair bills.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis

• At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p<0.0001)
  
  
• Both 25 mg and 50 mg obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control
  
  
• Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals
  
  
• Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure
  
  
• The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Q4 2026
  
  
• Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027
  
  
• Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results
  
  

PARIS, France – June 1, 2026 – 10:05 pm CEST – 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 positive topline results from the Phase 3 ABTECT maintenance trial evaluating obefazimod, its investigational oral, first-in-class miR-124 enhancer, in adults with moderately to severely active ulcerative colitis (“UC”). The results demonstrate that both the 25 mg and 50 mg doses of obefazimod met the primary endpoint of clinical remission and all key secondary endpoints at Week 44.

Marc de Garidel, MBA, Chief Executive Officer of Abivax, said: “Today’s landmark Phase 3 results highlight the exceptional potential of obefazimod to redefine the treatment landscape for ulcerative colitis. With its compelling durable efficacy and favorable safety profile, combined with the convenience of a once-daily oral treatment, obefazimod has the potential to transform UC patient care.”

David T. Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, commented: “The 44-week maintenance data demonstrate obefazimod’s potential to deliver meaningful efficacy and durable disease control in ulcerative colitis. The novel mechanism, sustained clinical remission, and favorable long-term safety profile highlight its potential to address a significant unmet need in UC.”

Topline Results

The Phase 3 ABTECT maintenance trial is a global 44-week multicenter, randomized, double-blind, placebo-controlled trial that evaluated the long-term efficacy and safety of obefazimod at 25 mg and 50 mg administered orally once-daily in adults with moderately to severely active UC. Participants who were clinical responders after the 8-week ABTECT-1 and ABTECT-2 induction trials (N=580) were re-randomized to receive 25 mg obefazimod, 50 mg obefazimod, or placebo.

Results from the trial demonstrated that obefazimod met the FDA primary endpoint of placebo-adjusted clinical remission at Week 44 in the 25 mg (∆39.3%, p<0.0001) and 50 mg (∆40.3%, p<0.0001) once-daily dose regimens in the Phase 3 maintenance trial. The trial also recorded a 10.4% placebo clinical remission rate, the lowest reported to date in a Phase 3 UC maintenance responder re-randomization trial.

Both doses of obefazimod met all key secondary endpoints (endoscopic improvement, endoscopic remission, HEMI¹, corticosteroid free clinical remission, and sustained clinical remission), demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control.

Obefazimod demonstrated an overall favorable safety profile in the Phase 3 ABTECT maintenance trial with no new safety signals observed, and the treatment was generally well tolerated.

Abivax intends to submit an NDA to the FDA in late fourth quarter 2026.

	FDA Primary Endpoint and Key Secondary Endpoints
	ABTECT-Maintenance (Study 107)
	Placebo (N=192)	25 mg (N=193)	50 mg (N=195)
Clinical Remission
Week 44 - n (%)	20 (10.4%)	98 (50.8%)	100 (51.3%)
Placebo-Adjusted ∆		∆39.3%	∆40.3%
P value		<0.0001	<0.0001
Endoscopic Improvement
Week 44 - n (%)	24 (12.5%)	106 (54.9%)	125 (64.1%)
Placebo-Adjusted ∆		∆42.5%	∆51.0%
P value		<0.0001	<0.0001
Endoscopic Remission
Week 44 - n (%)	19 (9.9%)	80 (41.5%)	93 (47.7%)
Placebo-Adjusted ∆		∆31.4%	∆37.8%
P value		<0.0001	<0.0001
HEMI
Week 44 - n (%)	20 (10.4%)	97 (50.3%)	112 (57.4%)
Placebo-Adjusted ∆		∆39.4%	∆46.5%
P value		<0.0001	<0.0001
Corticosteroid Free Clinical Remission
Week 44 - n (%)	19 (9.9%)	87 (45.1%)	93 (47.7%)
Placebo-Adjusted ∆		∆35.1%	∆38.0%
P value		<0.0001	<0.0001
Sustained Clinical Remission
Week 44 – n/N (%)	8/51 (15.7%)	49/73 (67.1%)	40/61 (65.6%)
Placebo-Adjusted ∆		∆52.8%	∆49.1%
P value		<0.0001	<0.0001

% Difference is for obefazimod minus placebo and is based on estimated common risk difference using the Mantel-Haenszel weights adjusting for the randomization stratification factors: clinical remission at maintenance baseline (yes/no), induction treatment (25 mg/50 mg), and maintenance baseline oral corticosteroids usage (yes/no); Clinical remission is defined as SFS = 0 or 1, and RBS = 0 and MES = 0 or 1; Endoscopic improvement is defined as MES = 0 or 1; Endoscopic remission is defined as MES = 0; HEMI is defined as MES = 0 or 1 and Geboes Index score <3.1; Corticosteroid-free clinical remission is defined as clinical remission (SFS = 0 or 1 and RBS = 0 and MES = 0 or 1) at Week 44 and corticosteroid free for at least 12 weeks immediately prior to Week 44; Sustained clinical remission is defined as clinical remission at Week 44 in the sub-population of subjects in clinical remission at Week 8 of the induction trial

	Safety Results Summary
	ABTECT-Maintenance (Study 107)
TEAEs2, n (%)	Placebo (N=192)	25 mg (N=193)	50 mg (N=195)
Any TEAE	96 (50.0%)	112 (58.0%)	140 (71.8%)
TEAE leading to study drug discontinuation	13 (6.8%)	5 (2.6%)	9 (4.6%)
Serious TEAE	8 (4.2%)	5 (2.6%)	11 (5.6%)
Death	0	0	0
Serious/severe (grade≥3) infections and opportunistic infections3	2 (1.0%)	2 (1.0%)	1 (0.5%)
Acute Pancreatitis	0	0	0
Cardiac abnormalities suggestive of cardiac fibrosis	0	0	0
Malignancies other than Non-Melanoma Skin Cancers (Non-NMSC)
Prostate Cancer	0	0	1 (0.5%)
Breast Cancer	0	0	1 (0.5%)
Colonic Dysplasia	0	0	1 (0.5%)
Non-Melanoma Skin Cancers (NMSC)
Basal Cell Carcinoma	1 (0.5%)	0	2 (1.1%)
Squamous Cell Carcinoma	0	1 (0.5%)	2 (1.1%)
Non-NMSC: The prostate, breast, and colon cancer cases were considered unrelated to treatment by investigators, and no organ-specific clustering was observed NMSC: Two of the four 50 mg patients were deemed not/unlikely related to drug by investigators; of the remaining two cases, one had a medical history of skin cancer The mean age of observed NMSC cases was 62 years, compared with 42 years in the overall trial population, consistent with age-related NMSC risk

Fabio Cataldi, MD, Chief Medical Officer of Abivax, added, “Today’s ABTECT maintenance results represent an important milestone for the obefazimod program and we thank the patients, investigators, and site staff who made this trial possible. The totality of the data reinforces obefazimod’s potential to meaningfully change the treatment landscape for ulcerative colitis. We look forward to sharing additional results from this trial at upcoming medical congresses and remain on track for NDA filing for obefazimod in ulcerative colitis by year end.”

Anticipated Upcoming Key Milestones

• Half-year financial results on September 21, 2026
• NDA submission for obefazimod in UC in Q4 2026
• Topline results of Phase 2b induction trial for Crohn’s disease in mid-year 2027

Investor Conference Call and Webcast

Abivax management will host an investor and analyst conference call today at 4:30 p.m. EDT / 10:30 p.m. CEST to discuss the topline results. To participate, please use the following dial-in or webcast link: https://edge.media-server.com/mmc/p/j7jbwm5g/

About the ABTECT Ulcerative Colitis Program

The global obefazimod ulcerative colitis program is evaluating more than 1,200 patients with moderately to severely active ulcerative colitis across three pivotal trials. These studies include assessments of efficacy and safety of obefazimod. More information on these trials can be found at www.clinicaltrials.gov (NCT05507203, NCT05507216, NCT05535946).

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 obefazimod’s potential to transform UC patient care, the timing for sharing additional results from the Phase 3 ABTECT maintenance trial, the expected timing for completion of the Phase 2b ENHANCE-CD induction trial of obefazimod and the availability and timing of results therefrom, the timing of regulatory filings including an NDA submission for obefazimod in UC, the timing for reporting Abivax’s half year 2026 financial results, 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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1HEMI: Histologic-Endoscopic Mucosal Improvement
2 Treatment-Emergent Adverse Events
3 Serious/Severe Infections and Opportunistic Infections: Placebo = Anal abscess, bronchitis & gastroenteritis, 25 mg = 1 Lymph node tuberculosis, 1 tonsillitis, 50 mg = 1 Appendicitis, focal peritonitis

Attachment

• 20260601_Abivax_PR_ABTECT_Ph3 Maintenance Data

FAQ

What were Abivax (ABVX) Phase 3 ABTECT maintenance results for obefazimod in ulcerative colitis?

Obefazimod achieved higher Week 44 clinical remission rates than placebo in the Phase 3 ABTECT maintenance trial. According to Abivax, remission reached 50.8% with 25 mg and 51.3% with 50 mg, versus 10.4% with placebo, with placebo-adjusted differences of 39.3% and 40.3% (p<0.0001).

Did both obefazimod doses meet key secondary endpoints in the ABTECT maintenance trial for ABVX?

Yes, both 25 mg and 50 mg obefazimod met all key secondary endpoints at Week 44. According to Abivax, this included endoscopic improvement, endoscopic remission, HEMI, corticosteroid-free clinical remission, and sustained clinical remission, showing consistent efficacy across multiple disease control measures in responders from the induction trials.

What safety profile did obefazimod show in Abivax (ABVX) Phase 3 ABTECT maintenance study?

Obefazimod showed an overall favorable 44-week safety profile with no new safety signals. According to Abivax, any treatment-emergent adverse events occurred in 50.0% (placebo), 58.0% (25 mg), and 71.8% (50 mg), with low rates of serious infections, no acute pancreatitis, and no cardiac fibrosis reports.

When does Abivax (ABVX) plan to submit the NDA for obefazimod in ulcerative colitis?

Abivax plans to submit a New Drug Application for obefazimod in ulcerative colitis in late Q4 2026. According to Abivax, the Phase 3 maintenance data support this timeline, and the company expects to remain on track for filing by year-end 2026, pending ongoing regulatory preparations.

What are the upcoming clinical milestones for Abivax (ABVX), including Crohn’s disease data?

Key upcoming milestones include half-year 2026 financial results and further clinical readouts. According to Abivax, topline results from the Phase 2b induction trial of obefazimod in Crohn’s disease are expected mid-year 2027, alongside the planned Q4 2026 NDA submission for ulcerative colitis in the United States.

How many patients were included in the ABTECT Phase 3 maintenance trial for Abivax (ABVX)?

The Phase 3 ABTECT maintenance trial enrolled 580 adults with moderately to severely active ulcerative colitis who had responded to induction. According to Abivax, these responders were re-randomized to once-daily 25 mg obefazimod, 50 mg obefazimod, or placebo for 44 weeks, assessing long-term efficacy and safety.

What long-term data support obefazimod’s durability for Abivax (ABVX) in ulcerative colitis?

Open-label extension data suggest durable clinical remission with long-term obefazimod exposure in ulcerative colitis. According to Abivax, Phase 2a/2b Study 108 showed sustained clinical remission and a favorable safety profile for up to seven years, complementing the 44-week Phase 3 maintenance efficacy and safety results.