regulatory
confidence high
sentiment positive
materiality 0.80
Biohaven submits NDA for troriluzole in SCA3; updates on Kv7, TYK2/JAK1, and SMA pipeline
Biohaven Ltd.
- Submitted NDA to FDA for troriluzole in SCA3, an ultra-rare disease affecting ~10,600 people in NA, EU, Japan.
- Phase 1 safety data for BHV-7000 (Kv7.2/3 activator) validates differentiated profile; pivotal studies in focal epilepsy and bipolar disorder planned in 2H2023.
- Initiated Phase 1 study for BHV-8000 (brain-penetrant TYK2/JAK1 inhibitor); Phase 2 in Parkinson's expected next year.
- Global Phase 3 trial of taldefgrobep alfa in SMA enrollment of ~225 patients expected to complete in 2023.
- IND for novel IgG degrader BHV-1300 on track for submission in 2023; multiple new INDs planned within next year.