---
schema_version: "secwatch.filing_event.v1"
accession: "0001935979-26-000077"
form_type: "8-K"
ticker: "BHVN"
cik: "0001935979"
company_name: "Biohaven Ltd."
filed_at: "2026-09-10T01:55:18+00:00"
generated_at: "2026-09-10T10:05:23.956742+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA partial clinical hold on BHV-7000 pauses new enrollment; dosing continues

## Summary
- FDA issued partial clinical hold letter Sept 4, 2026, pausing new patient enrollment pending nonclinical metabolite data.
- Dosing continues for >600 already randomized patients; BHV7000-303 fully enrolled, topline on track for H2 2026.
- BHV7000-302 new enrollment paused; open-label extension continues dosing; global sites voluntarily paused outside U.S.
- Over 1,200 participants dosed to date; metabolite findings may be rodent-specific and of uncertain human relevance.
- Aug 26, 2026 license agreement with SK Biopharmaceuticals for Kv7 platform incl. BHV-7000; HSR submission pending.

## SEC filing metadata
- accession: 0001935979-26-000077
- form_type: 8-K
- ticker: BHVN
- cik: 0001935979
- company_name: Biohaven Ltd.
- filed_at: 2026-09-10T01:55:18+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/0001935979-26-000077-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/bhvn-20260904.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001935979-26-000077
- JSON: https://secwatch.observer/filing/0001935979-26-000077.json
- Plain text: https://secwatch.observer/filing/0001935979-26-000077.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.