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Thursday, June 1, 2023

Biohaven Details Clinical Progress, Regulatory Updates, and Pipeline Developments at R&D Day

 

  • Submitted a new drug application (NDA) for troriluzole in Spinocerebellar Ataxia Type 3 (SCA3) to U.S. FDA in 2Q2023, marking the team's fourth NDA in approximately 3 years

  • Released additional data from Kv7 platform, including Phase 1 safety data by dose groups for BHV-7000 that further validates differentiated profile

  • Projected Phase 3 Spinal Muscular Atrophy trial to complete enrollment in 2023

  • Initiated Phase 1 study of brain penetrant TYK2/JAK1 inhibitor, BHV-8000, and anticipate beginning Phase 2 trial in Parkinson's disease next year

  • Highlighted robust pipeline with multiple INDs planned to be filed within the next year, including pan IgG degrader for multiple immune-mediated diseases in 2023

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