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Biohaven (BHVN) FDA Events

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FDA Events for Biohaven (BHVN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Biohaven (BHVN). Over the past two years, Biohaven has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BHV-1300, BHV-1400, BHV-1510, BHV-2100, BHV4157-206-RWE, BHV-7000, and BHV-8000. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Biohaven's Drugs in FDA Review

BHV-1300 - FDA Regulatory Timeline and Events

BHV-1300 is a drug developed by Biohaven for the following indication: For the potential treatment of autoimmune disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BHV-1400 - FDA Regulatory Timeline and Events

BHV-1400 is a drug developed by Biohaven for the following indication: For IgA nephropathy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BHV-1510 - FDA Regulatory Timeline and Events

BHV-1510 is a drug developed by Biohaven for the following indication: In Advanced or Metastatic Epithelial Tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BHV-2100 - FDA Regulatory Timeline and Events

BHV-2100 is a drug developed by Biohaven for the following indication: In the acute treatment of migraine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BHV4157-206-RWE - FDA Regulatory Timeline and Events

BHV4157-206-RWE is a drug developed by Biohaven for the following indication: To assess the effectiveness of troriluzole in Spinocerebellar Ataxia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BHV-7000 - FDA Regulatory Timeline and Events

BHV-7000 is a drug developed by Biohaven for the following indication: For the treatment of epilepsy and mood disorders. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BHV-8000 - FDA Regulatory Timeline and Events

BHV-8000 is a drug developed by Biohaven for the following indication: For Neuroinflammatory and Neurodegenerative Diseases. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Troriluzole (SCA) - FDA Regulatory Timeline and Events

Troriluzole (SCA) is a drug developed by Biohaven for the following indication: Spinocerebellar Ataxia (SCA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Biohaven FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Biohaven (BHVN) has reported FDA regulatory activity for the following drugs: Troriluzole (SCA), BHV-8000, BHV-1400, BHV-1510, BHV-7000, BHV-1300, BHV-2100 and BHV4157-206-RWE.

The most recent FDA-related event for Biohaven occurred on May 29, 2025, involving BHV-8000. The update was categorized as "Study Initiation," with the company reporting: "Biohaven Ltd that it has initiated a global Phase 2/3 study of the first-in-clinic, orally-administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, BHV-8000, for the treatment of early Parkinson's disease (PD)."

Current therapies from Biohaven in review with the FDA target conditions such as:

  • Spinocerebellar Ataxia (SCA) - Troriluzole (SCA)
  • For Neuroinflammatory and Neurodegenerative Diseases - BHV-8000
  • For IgA nephropathy - BHV-1400
  • In Advanced or Metastatic Epithelial Tumors - BHV-1510
  • For the treatment of epilepsy and mood disorders - BHV-7000
  • For the potential treatment of autoimmune disease. - BHV-1300
  • In the acute treatment of migraine. - BHV-2100
  • To assess the effectiveness of troriluzole in Spinocerebellar Ataxia. - BHV4157-206-RWE

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:BHVN) was last updated on 7/10/2025 by MarketBeat.com Staff
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