BHV-7000

May 12, 2025: Biohaven Ltd. (NYSE: BHVN) reported Q1 2025 results and provided regulatory/clinical catalysts across its pipeline. The company completed an FDA mid-cycle review meeting and FDA inspections for the troriluzole NDA in spinocerebellar ataxia (SCA, all genotypes); Biohaven said review continuity and timelines remain maintained, FDA has not conveyed intent to hold an Advisory Committee, and the application has Priority Review with a PDUFA action date expected in 3Q 2025. Biohaven is preparing for a potential SCA commercial launch in 2025.

Financing: In April 2025 Biohaven signed up to a $600M non-dilutive note purchase agreement with Oberland Capital; $250M was funded at close (April 30, 2025). A second tranche up to $150M is contingent on FDA approval of troriluzole; a third tranche up to $200M is by mutual agreement for strategic acquisitions. Oberland is entitled to milestone/royalty economics tied to regulatory approval and global net sales of troriluzole (capped at a multiple).

Other expected 2025–2026 milestones cited: pivotal topline data for troriluzole in two Phase 3 OCD trials (1H 2025 and 2H 2025); BHV-7000 (Kv7 activator) pivotal MDD topline (2H 2025) and focal epilepsy topline (1H 2026); BHV-2100 acute migraine proof-of-concept data (1H 2025); BHV-8000 Phase 2/3 initiation in Parkinson’s disease (1H 2025); MoDE degrader Phase 1 completions (BHV-1300/1400/1600) in 1H 2025 with BHV-1300 Phase 1b in Graves’ disease mid-2025; oncology ADC updates including preliminary Phase 1 data for BHV-1510 in 2025 and Phase 1 initiation for BHV-1530 in 1H 2025; taldefgrobep alfa FDA interaction on SMA path and Phase 2 obesity study initiation (both 1H 2025).