Abivax Jumps 34% on Obefazimod Safety Data as 37% Late Responders Reached Remission
Updated
Updated · CNBC · Jun 30
Abivax Jumps 34% on Obefazimod Safety Data as 37% Late Responders Reached Remission
3 articles · Updated · CNBC · Jun 30
Summary
Abivax shares surged 34% to 111.7 euros after new Phase 3 data said malignancy rates for obefazimod were in line with those normally seen in ulcerative colitis patients.
The update addressed a June 2 selloff, when the stock crashed about 44% after the company disclosed seven cancer cases in the study's highest-dose cohort.
More than 37% of patients who did not initially respond later achieved clinical remission on the 50 mg dose after about 10 months in the 44-week maintenance study.
Jefferies called the data supportive but warned cancer-risk concerns, limited near-term catalysts and cash needs could still deter generalist investors.
Abivax said it remains on track to file a U.S. FDA new drug application in the fourth quarter of 2026, with a Crohn's disease readout expected in mid-2027.
Can Abivax's drug overcome its initial cancer scare to truly become a blockbuster therapy for colitis patients?
With Merck’s new drug also showing promise, can obefazimod truly dominate the multi-billion dollar ulcerative colitis market?
Obefazimod’s Phase 3 Success in Ulcerative Colitis: Record Remission Rates, Cancer Concerns, and Regulatory Outlook
Overview
Obefazimod, an oral therapy for moderately to severely active ulcerative colitis, achieved a major milestone with its Phase 3 trial meeting all primary endpoints and showing strong efficacy across multiple disease control measures. The drug delivered impressive clinical, endoscopic, and histologic improvements, leading analysts to call it potentially 'best-in-disease' after posting the highest placebo-adjusted remission rates seen in long-term UC trials. These results, combined with a favorable safety profile and positive market reaction, highlight obefazimod's promise as a transformative treatment option and set the stage for its upcoming regulatory review and commercial launch.