Biohaven Ltd. BHVN
Biohaven Ltd. (NYSE: BHVN) is a CNS/neurology/psychiatry drug developer. Its lead program, Opakalim (BHV-7000), is in Phase 3 for Refractory focal epilepsy (adults). Its next catalyst on record is Opakalim (BHV-7000): RISE 3 topline results (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Opakalim (BHV-7000) — RISE 3 topline results (H2 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Opakalim (BHV-7000) | Refractory focal epilepsy (pivotal Phase 2/3 program RISE 2 and RISE 3; RISE 3 enrollment complete June 2026; OLE ongoing) | small molecule | Phase 3 |
| BHV-1300 (MoDE IgG degrader) | Graves' disease (pivotal randomized trial, ~300 adults, underway) | protein/peptide | Phase 3 |
| Troriluzole | Spinocerebellar ataxia and OCD (Phase 2/3 program referenced; current NDA status not stated in the extract) | small molecule | Phase 3 |
| Taldefgrobep alfa (BHV-2000) | Obesity (Phase 2 proof-of-concept, ~150 pts, enrollment complete) | protein/peptide | Phase 2 |
| BHV-1400 (TRAP Gd-IgA1 degrader) | IgA nephropathy (Phase 1b expansion in patients; pivotal study planned) | protein/peptide | Phase 1 |
| BHV-1530 (ADC) | FGFR3-altered advanced solid tumors (Phase 1 dose escalation) | antibody | Phase 1 |
| BHV-8100 (PKM2 activator) | Neurodegenerative, ophthalmic and immunologic disorders (Phase 1 SAD in healthy volunteers) | small molecule | Phase 1 |
Recent results and decisions
- Oct 22, 2026accepted FDA accepts NDA resubmission for troriluzole in SCA with PDUFA goal date in Q1 2027 and plans advisory committee meeting.
The FDA has informed Biohaven that the company's new drug application resubmission for Vyglxia (troriluzole) in SCA has been accepted for review.
Filing - Oct 22, 2026adcomm positive FDA plans to convene advisory committee meeting for troriluzole in SCA, date to be announced.
The FDA plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee to obtain input from external stakeholders.
Filing - Sep 4, 2026clinical hold FDA issued a partial clinical hold on new patient enrollment across the BHV-7000 program pending nonclinical data on a rodent metabolite; dosing of >600 randomized patients continues.
FDA instructed the Company to pause new enrollment until additional clarifying nonclinical studies are completed, and issued a partial clinical hold letter on September 4, 2026 that pauses new patient enrollment pending the results of additional nonclinical data regarding the metabolite.
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.