Why Is Abivax Stock Skyrocketing Tuesday?

Abivax SA (NASDAQ: ABVX ) on Monday shared additional Phase 3 maintenance data for investigational ulcerative colitis therapy obefazimod.

Following the announcement, the stock jumped nearly 36%.

Abivax Reports Strong Phase 3 Maintenance Results For Obefazimod The data showed continued clinical benefit in patients who initially failed induction therapy or relapsed during maintenance treatment.

The results also expanded the drug’s safety database as the company prepares a planned U.S. regulatory submission later this year.

The newly released topline findings come from ABTECT Maintenance Part 2, a supplemental portion of the company’s Phase 3 ulcerative colitis maintenance program.

The trial enrolled adults with moderately to severely active ulcerative colitis who either did not achieve a clinical response after induction treatment or experienced disease relapse during the randomized maintenance study.

According to the company, patients who continued receiving obefazimod despite failing to respond after eight weeks of induction achieved clinically meaningful outcomes by Week 44 across multiple efficacy measures.

Read Also: What's Going On With Abivax Stock On Thursday? Patients treated continuously with the 50 mg dose recorded a 37.2% clinical remission rate, a 61.5% clinical response rate, 48.0% endoscopic improvement, 44.6% histologic-endoscopic mucosal improvement and a 34.5% endoscopic remission rate.

The findings suggest some patients who do not respond early may benefit from extended treatment.

Re-Treatment Restored Disease Control After Relapse The company also reported positive results among patients who relapsed during Maintenance Part 1.

Patients who initially responded during induction but relapsed after switching to placebo achieved clinical response and remission rates of 69.7% and 45.0%, respectively, after receiving open-label 50 mg obefazimod.

Patients who relapsed while taking 25 mg and escalated to 50 mg posted corresponding response and remission rates of 66.7% and 45.5%.

Abivax said the results support the potential for obefazimod to regain disease control following relapse while providing flexibility in long-term maintenance treatment.

Safety Findings Support Planned FDA Submission The company said the overall safety profile in Maintenance Part 2 remained consistent with previous studies, with no new safety signals emerging despite additional patient exposure.

Four non-melanoma skin cancer events were reported during Part 2—two each in the 25 mg and 50 mg treatment groups—all occurring in patients with established risk factors.

Two additional non-skin cancer malignancies reported in the 50 mg arm were deemed unrelated to obefazimod by study investigators.

Abivax said the expanded Phase 3 maintenance dataset strengthens the integrated clinical package supporting its planned New Drug Application for obefazimod in ulcerative colitis.

The company remains on track to submit the application to the U.S.

Food and Drug Administration in the fourth quarter of 2026.

Looking ahead, Abivax anticipates topline results from its Phase 2b ENHANCE-CD induction trial in Crohn’s disease by mid-2027.

Abivax Price Action ABVX Stock Price Activity: Abivax shares were up 35.80% at $130.57 during premarket trading on Tuesday, according to Pro data.

Photo by MMD Creative via Shutterstock Read Also: Amazon Sued By Australia's Competition Watchdog Over Prime Video Ad Rollout