Abivax: phase 3 data delayed to Q2 2025
(CercleFinance.com) - Abivax announced on Tuesday that first results from its Phase 3 trial in ulcerative colitis (UC) are now expected at the beginning of Q2 2025, rather than in Q1 2025.
The biotech company reports that the study - which is evaluating its drug candidate Obefazimod in moderately to severely active UC - is progressing 'favorably' at this stage.
Patient enrolment is therefore expected to be completed early in Q1 2025, meaning that the first eight-week results should be available early in Q2 2025.
The 44-week maintenance data, on the other hand, are not expected to be released before Q1 2026.
In a reaction note, Oddo BHF analysts see this delay as a "marginal delay", and maintain their "outperform" rating on the stock.
In its press release, the biotech asserts that it still expects to be in a position to submit a marketing application to the FDA at the end of the 1st half of 2026.
As things stand, its cash position should enable it to carry out its activities until the 4th quarter of 2025.
Following these announcements, Abivax shares advanced by 0.9% on Tuesday morning on the Paris Bourse.
Copyright (c) 2024 CercleFinance.com. All rights reserved.