Abivax inflammatory bowel drug shows benefit in relapsed and non-responding patients (updated)

Abivax SA

29/06/2026 23:17

 (Adds shares in paragraph 1, conference call comment in
paragraph 7)
    By Puyaan Singh
    June 29 (Reuters) - Abivax  ABVX.PA  said on Monday its
experimental ulcerative colitis drug helped harder-to-treat
groups of patients achieve remission, sending U.S.-listed shares
of the Paris-based company soaring 26.4% in extended trading.
    The company said 37.2% of patients who had not responded to
an initial induction treatment of obefazimod achieved clinical
remission after continued treatment at a 50 milligram dose at
week 44, while 34.5% achieved endoscopic remission.
    Separately, among patients who relapsed during the first
part of the maintenance phase, increasing the dose to 50 mg
recaptured clinical remission in 45.5%, Abivax said.
    The results follow June 1 data from the same trial where
50.8% of patients on the 25 mg dose and 51.3% on the 50 mg dose
achieved clinical remission, compared with 10.4% on placebo.
    Shares in Abivax sank after the June 1 readout as investors
focused on cancer cases reported in patients taking the higher
dose, though investigators considered the cases unrelated to
treatment.
    Abivax said the expanded safety dataset, covering 1,704
patient-years of drug exposure, showed that cancer rates were in
line with those normally seen in ulcerative colitis patients.
    Abivax's head of regulatory affairs, Keith Fournier, said
that "four independent former FDA senior leaders ... considered
it highly unlikely that (the FDA's strictest) boxed warning
would be required." The experts don't expect significant
additional testing or referral requirements, Fournier said.
    Obefazimod is an oral miR-124 enhancer designed to regulate
inflammatory responses. Abivax has said it plans to submit a
U.S. marketing application in late 2026.

 (Reporting by Puyaan Singh in Bengaluru; Editing by Vijay
Kishore and Sahal Muhammed)
 ((VijayKishore.Vaidyanathan@thomsonreuters.com;))