FDA refuses troriluzole NDA for SCA; BHV-7000 EEG data positive

Biohaven Ltd.

FDA refused to file troriluzole NDA for SCA because primary endpoint not met; company may request Type A meeting within 30 days.
BHV-7000: preliminary EEG data shows target engagement with no somnolence/fatigue; pivotal studies in epilepsy/bipolar disorder planned for 2H2023.
BHV-8000 Phase 1: three dose cohorts dosed, well tolerated, achieved projected therapeutic concentrations; Phase 2 in Parkinson's planned for 2024.
BHV-1300 bispecific IgG degrader advancing to IND in 2H2023; competitive safety and manufacturing profile.
Once-daily extended-release formulation for BHV-7000 confirmed for Phase 2/3 programs.

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