Biohaven: Opakalim Seizure Control and Biomarker Wins

Biohaven's Opakalim Seizure Control and Biomarker Wins

Biohaven reported prolonged seizure control with opakalim and deep biomarker reductions with BHV-1300 and BHV-1400 ahead of mid-2026 pivotal starts.

Opakalim Seizure Control

Opakalim 75 mg once-daily tripled median time to second generalized tonic-clonic seizure (141 days vs. 47 days placebo). In focal epilepsy open-label extension, 54% of patients achieved ≥50% seizure reduction over six months.

Safety Profile

Opakalim was well tolerated across studies (1,000+ subjects) with low CNS adverse event rates (no somnolence, dizziness, fatigue, or memory impairment).

BHV-1300 and BHV-1400 Biomarker Wins

BHV-1300 (MoDE) reduced pathogenic TSHR-IgG1 >80% by week 12 and normalized T4 and T3 in Graves' patients. BHV-1400 (TRAP) cut Gd-IgA1 >60% within 48 hours and ~70% by one month, with early eGFR, UPCR, and hematuria improvements. Both programs are set to start Phase 3 in mid-2026.