PRAX - Praxis Precision dips 11% as FDA recommended further inspection on PRAX-114 application

Praxis Precision Medicines (PRAX) drops 11% premarket in reaction to receiving comments from the FDA on the full clinical hold of its Investigational New Drug ((IND)) submission for PRAX-114 for the treatment of major depressive disorder. The IND for PRAX-114 was placed on clinical hold by the FDA pending the resolution of certain non-clinical pharmacology and toxicology matters.In its comment letter, the Agency proposed that the Company conduct further toxicological investigation of the effect of PRAX-114 and its metabolites on fertility, reproduction, and embryofetal development to support the planned trial.Praxis Precision believes that the results of its ongoing fertility and reproductive studies, expected to be completed in Q1 2021, together with the available toxicology package will satisfy the FDA request.The FDA also requested updates to the Investigator’s Brochure and to the requirements for contraception in the protocol. The Company now expects to initiate the randomized, placebo-controlled Phase 2/3 clinical trial for PRAX-114 in

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Praxis Precision dips 11% as FDA recommended further inspection on PRAX-114 application