DGAP-News: ABIVAX / Key word(s): Study
13.01.2022 / 08:00
The issuer is solely responsible for the content of this announcement.
Abivax receives EMA Scientific Advice supportive of moving ABX464 into phase 3 clinical testing in ulcerative colitis
PARIS, France, January 13, 2022 – 8:00 pm (CET) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases and cancer, today announced that the European Medicines Agency (EMA) provided their feedback in the context of the scientific advice meeting that supports advancing ABX464 into phase 3 clinical testing for the treatment of ulcerative colitis and subsequent potential marketing authorization submission and commercialization.
In November 2021, Abivax received written responses from the US regulatory agency FDA in the context of the End-of-Phase-2 meeting. This feedback was recently complemented by a separate FDA CMC Type C meeting, focusing on manufacturing aspects, as well as the responses from EMA to a…
