COMPANY

Biohaven

Biohaven is a biopharmaceutical company. From company website Source · Oct 12, 2026

Keywords: biopharmaceutical Focal Epilepsy Spinocerebellar Ataxias Obsessive-Compulsive Disorder Lou Gehrig Disease Graves Disease IgA Nephropathy Major Depressive Disorder Bipolar Disorder Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Parkinson Disease Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 Spinocerebellar Ataxia Type 7 Spinocerebellar Ataxia Type 8 Spinocerebellar Ataxia Type 10 Spinal Muscular Atrophy Neuromuscular Diseases SMA Familial Erythromelalgia Generalized Epilepsy Obesity Overweight Migraine Spinocerebellar Ataxia Genotype Type 1 Spinocerebellar Ataxia Genotype Type 2 Spinocerebellar Ataxia Genotype Type 3 Spinocerebellar Ataxia Genotype Type 6 Spinocerebellar Ataxia Genotype Type 7 Spinocerebellar Ataxia Genotype Type 8 Spinocerebellar Ataxia Genotype Type 10 Multiple Myeloma Generalized Anxiety Disorder Alzheimer Disease Multiple System Atrophy

Profile checked Oct 10, 2026

$600.0MRaised (2 yrs)34Trials (company is sponsor)

Trial and FDA signals

FDA complete response letter Received an FDA complete response letter (NDA 210862, letter dated Nov 4, 2025). FDA NDA 210862 (Nov 4, 2025)
Evidence (1 event)
- Nov 4, 2025 · FDA NDA 210862
  CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Biohaven Therapeutics, Ltd. c/o Biohaven Pharmaceuticals, Inc. Attention: Marianne Frost, MA Senior VP, Regulatory Affairs and Operations New Haven, CT (street omitted) Dear M

Job counts as of Oct 18, 2026. All trial and FDA signals

Timeline

Aug 26, 2026 Partnership Partnership / licensing: $400M (upfront, as published); deal value up to $795M (kept separate from upfront), announced Aug 26, 2026. Source: SEC filing. source ↗
Jun 26, 2026 Trial start Phase 3: Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease source ↗
2026-06 Trial start Phase 3: A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy source ↗
Jan 15, 2026 Trial start 1: A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia source ↗
Nov 24, 2025 Trial start Phase 2: Taldefgrobep Alfa in Adults With Overweight and Obesity source ↗
Aug 21, 2025 Trial start Phase 1: Study of BHV-1300 in Graves' Disease source ↗
Jul 30, 2025 Trial start Phase 1: Study of BHV-1400 in IgA Nephropathy source ↗
May 28, 2025 Trial start Phase 2/Phase 3: A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease source ↗
Apr 28, 2025 Raise Private placement: $600M (up to, as announced), announced Apr 28, 2025. Source: SEC filing. source ↗
Mar 20, 2025 Trial start 1: A Phase 1 Study of BHV-1530 in Advanced Solid Tumors source ↗
Oct 10, 2024 Trial start Phase 2: Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine source ↗
Aug 1, 2024 Trial start Phase 2: Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD) source ↗
Jul 30, 2024 Trial start Phase 2: Long-term Safety and Tolerability of BHV-7000 source ↗
Jun 24, 2024 Trial start Phase 2: BHV-7000 Open-Label Extension Bipolar Mania Study source ↗
Jun 20, 2024 Trial start Phase 2/Phase 3: A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures source ↗
May 28, 2024 Trial start Phase 2: Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression source ↗
May 28, 2024 Trial start Phase 2/Phase 3: BHV-7000 Acute Treatment of Bipolar Mania source ↗
May 13, 2024 Trial start Phase 2/Phase 3: Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy source ↗
Apr 22, 2024 Trial start 1: A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors source ↗
Mar 14, 2024 Trial start Phase 2/Phase 3: A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy source ↗
Jul 6, 2022 Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy source ↗
Oct 21, 2021 Trial start Phase 1: Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients source ↗
Mar 30, 2021 Trial start Phase 3: Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder source ↗
Jan 29, 2021 Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder source ↗
Dec 22, 2020 Trial start Phase 3: Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder source ↗

Showing 25 of 33 dated events.

Upcoming milestones

2026-10 (ESTIMATED) · Phase 2/Phase 3 · Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy · NCT06309966
2026-11 (ESTIMATED) · 1 · A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia · NCT07262268
2026-12 (ESTIMATED) · Phase 2/Phase 3 · A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy · NCT06132893
2026-12 (ESTIMATED) · Phase 2 · Long-term Safety and Tolerability of BHV-7000 · NCT06443463
2027-07 (ESTIMATED) · Phase 1 · Study of BHV-1400 in IgA Nephropathy · NCT07054684
2027-08 (ESTIMATED) · Phase 2/Phase 3 · A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease · NCT06976268
2027-09 (ESTIMATED) · Phase 1 · Study of BHV-1300 in Graves' Disease · NCT06980649
2028-01 (ESTIMATED) · Phase 3 · Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease · NCT07661056

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $600.0M. Last 2 years.

Apr 28, 2025 Private placement: $600M (up to, as announced), announced Apr 28, 2025. Source: SEC filing. source ↗
Aug 26, 2026 Partnership / licensing: $400M (upfront, as published); deal value up to $795M (kept separate from upfront), announced Aug 26, 2026. Source: SEC filing. source ↗

Clinical trials (lead sponsor) 34

Record	Title	Phase	Status	Start	Primary completion
NCT07661056	Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease	Phase 3	Recruiting	Jun 26, 2026	2028-01 (estimated)
NCT06132893	A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy	Phase 2/Phase 3	Active, not recruiting	Mar 14, 2024	2026-12 (estimated)
NCT06384807	A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors	1	Recruiting	Apr 22, 2024	2028-02 (estimated)
NCT06976268	A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease	Phase 2/Phase 3	Recruiting	May 28, 2025	2027-08 (estimated)
NCT06309966	Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy	Phase 2/Phase 3	Active, not recruiting	May 13, 2024	2026-10 (estimated)
NCT06980649	Study of BHV-1300 in Graves' Disease	Phase 1	Recruiting	Aug 21, 2025	2027-09 (estimated)
NCT06874335	A Phase 1 Study of BHV-1530 in Advanced Solid Tumors	1	Recruiting	Mar 20, 2025	2029-03 (estimated)
NCT03701399	Troriluzole in Adult Participants With Spinocerebellar Ataxia	Phase 3	Active, not recruiting	Mar 8, 2019	Feb 18, 2022 (actual)
NCT07054684	Study of BHV-1400 in IgA Nephropathy	Phase 1	Recruiting	Jul 30, 2025	2027-07 (estimated)
NCT07642050	A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy	Phase 3	Not yet recruiting	2026-06	2028-09 (estimated)
NCT06529146	Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control	Not listed	Active, not recruiting	Mar 18, 2019	Sep 6, 2024 (actual)
NCT05337553	A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy	Phase 3	Active, not recruiting	Jul 6, 2022	Sep 25, 2024 (actual)
NCT04693351	A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder	Phase 3	Completed	Jan 29, 2021	Apr 29, 2025 (actual)
NCT06443463	Long-term Safety and Tolerability of BHV-7000	Phase 2	Enrolling by invitation	Jul 30, 2024	2026-12 (estimated)
NCT07262268	A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia	1	Enrolling by invitation	Jan 15, 2026	2026-11 (estimated)
NCT06423781	Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)	Phase 2	Completed	Aug 1, 2024	Mar 18, 2026 (actual)
NCT06425159	A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures	Phase 2/Phase 3	Terminated	Jun 20, 2024	Mar 12, 2026 (actual)
NCT07281495	Taldefgrobep Alfa in Adults With Overweight and Obesity	Phase 2	Active, not recruiting	Nov 24, 2025	2026-09 (estimated)
NCT06603623	Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine	Phase 2	Completed	Oct 10, 2024	Mar 24, 2025 (actual)
NCT04708834	Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder	Phase 3	Terminated	Mar 30, 2021	Feb 13, 2026 (actual)
NCT03299166	Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder	Phase 2/Phase 3	Completed	Dec 19, 2017	Jun 2, 2020 (actual)
NCT06034886	Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)	Not listed	Available	Not listed	Not listed
NCT04641143	Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder	Phase 3	Completed	Dec 22, 2020	Oct 27, 2025 (actual)
NCT06419608	Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression	Phase 2	Completed	May 28, 2024	Nov 7, 2025 (actual)
NCT06419582	BHV-7000 Acute Treatment of Bipolar Mania	Phase 2/Phase 3	Completed	May 28, 2024	Jan 15, 2025 (actual)
NCT06423794	BHV-7000 Open-Label Extension Bipolar Mania Study	Phase 2	Terminated	Jun 24, 2024	Apr 25, 2025 (actual)
NCT02960893	Trial in Adult Participants With Spinocerebellar Ataxia (SCA)	Phase 2/Phase 3	Completed	Dec 15, 2016	Aug 18, 2017 (actual)
NCT04634435	Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients	Phase 1	Completed	Oct 21, 2021	Jan 10, 2025 (actual)
NCT03829241	Randomized Trial of Adult Participants With Generalized Anxiety Disorder	Phase 3	Completed	Feb 19, 2019	Jan 14, 2020 (actual)
NCT03605667	Study of BHV-4157 in Alzheimer's Disease	Phase 2	Completed	Jul 31, 2018	Dec 15, 2020 (actual)
NCT03952806	Study of BHV-3241 in Participants With Multiple System Atrophy	Phase 3	Completed	Jul 29, 2019	Jul 29, 2021 (actual)
NCT03520517	Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS	Phase 1	Completed	Feb 2, 2018	Oct 8, 2018 (actual)
NCT05086094	Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)	Not listed	No longer available	Not listed	Not listed
NCT03537807	Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)	Not listed	No longer available	Not listed	Not listed