Biohaven Pharmaceutical Holding Company Ltd BHVN is eyeing filing for approval in early 2022 for its experimental pain spray after new data showed it hit its primary endpoints in a Phase 3 trial.
- The drug, zavegepant, a small-molecule CGRP receptor that can work as a spray and an oral med, showed "ultra-rapid pain relief" at the earliest measured time point of 15 minutes and sustained efficacy through 48 hours after a single intranasal dose in acute migraine.
- It hit its co-primary endpoints, namely pain freedom and freedom from "most bothersome" symptoms at two hours.
- It also showed "broad efficacy" after showing statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures.
- The nearly 1,500-patient study found the drug was generally clean on safety, with most adverse events mild in intensity.
- It will hope to nab another FDA migraine approval after getting a recent green light for Nurtec for acute migraine earlier in the year.
- Read Next: Pfizer Gains Outside US Rights To Biohaven's Migraine Treatment For $500M.
- Alongside the data, the company announced Vlad Coric would also take on the chairman of the board position. It hired a new chief financial officer Matthew Buten, a former managing director of Foresite Capital.
- The move comes after the former chair of Declan Doogan, and CFO James Engelhart announced they were retiring from their positions.
- Price Action: BHVN shares are down 3.58% at $99.85 during the market session on the last check Monday.
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