Biohaven Ltd. BHVN
Biohaven Ltd. (NYSE: BHVN) is an immunology/inflammation drug developer. Its lead program, BHV-1300 (MoDE pan-IgG degrader), is in Phase 3 for Graves' disease. Its next catalyst on record is Opakalim (BHV-7000): SK Biopharmaceuticals license closing (final closing conditions) (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Opakalim (BHV-7000) — SK Biopharmaceuticals license closing (final closing conditions) (Q4 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| BHV-1300 | Graves' disease | bispecific protein degrader | Phase 3 |
| Opakalim (BHV-7000) | Focal epilepsy | small molecule (Kv7 channel activator) | Phase 3 |
| Vyglxia (troriluzole) | Spinocerebellar ataxia | small molecule | Phase 3 |
| Taldefgrobep alfa (BHV-2000) | Obesity | protein/peptide (anti-myostatin adnectin) | Phase 2 |
| BHV-1400 (TRAP degrader) | IgA nephropathy | bispecific protein degrader | Phase 1 |
| BHV-1530 (ADC) | Advanced urothelial cancer, HNSCC, NSCLC | antibody drug conjugate | Phase 1 |
| BHV-8100 (PKM2 modulator) | Neurodegenerative diseases (Alzheimer's, MS, Parkinson's), retinal disorders, immunological disorders | small molecule | Phase 1 |
| BHV-1310 (next-gen MoDE pan IgG degrader) | Immunological diseases | bispecific protein degrader | Pre-clinical |
| BHV-1320 (next-gen MoDE pan IgG degrader) | Immunological diseases | bispecific protein degrader | Pre-clinical |
Recent results and decisions
- Oct 29, 2026accepted FDA accepted NDA resubmission for Vyglxia in spinocerebellar ataxia with user fee goal date in Q1 2027.
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, 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
11 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 immunology/inflammation companies
- Sanofi SNY
- Argenx SE ARGX
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Celldex Therapeutics, Inc. CLDX
- BioCryst Pharmaceuticals, Inc. BCRX
- Zenas BioPharma ZBIO
- Nektar Therapeutics NKTR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.