Biohaven Pharmaceutical Holding (NYSE:BHVN) has received a letter from FDA that it may proceed with its clinical investigation of BHV-3241, a novel myeloperoxidase inhibitor, developed for treatment of multiple system atrophy (MSA).
The FDA May Proceed Letter was received following Biohaven’s reactivation of IND application initially filed by AstraZeneca prior to licensing the compound to Biohaven.
The Company expects to start Phase 3 trial in Q3 2019.
BHV-3241 is an oral, brain-penetrant, irreversible inhibitor of MPO, an enzyme that acts as a key driver of pathological oxidative stress and inflammation in the brain.
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