- In its Q1 report, Biohaven Pharmaceutical (NYSE:BHVN) announces the following key future events for the year:
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CGRP receptor antagonist platform:
- Report initial results from a long-term safety study evaluating rimegepant in Q4 2018.
- Report top-line results from a Phase 3 rimegepant Zydis ODT trial in Q4 2018.
- Submit an IND and initiate a Phase 1 trial evaluating BHV-3500 for the acute treatment and prevention of migraine in 2018.
- Submit an NDA for rimegepant to the FDA in 2019, having previously announced positive topline data from its first two pivotal Phase 3 trials.
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Glutamate modulator platform:
- Complete enrollment in a Phase 2 trial evaluating trigriluzole in OCD in 2018.
- Report top-line results from a Phase 3 spinocerebellar ataxia long-term extension study in Q4 2018.
- Initiate a Phase 2 clinical trial evaluating trigriluzole in Alzheimer's disease in collaboration with the Alzheimer's Disease Cooperative Study Group in Q2 2018.
- Submit an NDA to the FDA via the 505(b)(2) pathway for BHV-0223 in patients with ALS in the second half of 2018.
- Complete a Phase 1 trial for BHV-5000 in 2018.