Abivax: the EMA endorses the phase 3 clinical program


(CercleFinance.com) – Abivax shares climbed more than 7% on the Paris Stock Exchange on Thursday after a favorable opinion from the European Medicines Agency (EMA), which supports the advancement of the phase 3 clinical program in the hemorrhagic rectocolitis.

The health authority considered that the pivotal phase 3 program did not raise any questions on the clinical safety and considered that the doses of 25 mg and 50 mg (highest dose) of ABX464 were ‘adequate’ to carry out the studies. induction and maintenance.

Last November, biotech had already received a favorable response from the US regulatory agency (FDA).

Abivax recalls that it has recorded “very good results” in its phase 2a and 2b studies, particularly with regard to clinical remission data.

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