8-K
filed May 27, 2026, 5:13 PM ET
ticker BHVN
CIK 0001935979
other material
confidence high
sentiment positive
materiality 0.95
Biohaven reports positive clinical data for opakalim in epilepsy and BHV-1300/BHV-1400 in autoimmune diseases at R&D Day
Biohaven Ltd.
- Opakalim 75 mg prolonged median time to second seizure to 141 days vs 47 days for placebo in idiopathic generalized epilepsy trial.
- 54% of focal epilepsy patients on opakalim achieved ≥50% seizure reduction over six months in open-label extension.
- BHV-1300 reduced pathogenic TSHR-IgG1 >80% by week 12 and normalized thyroid hormones within weeks in Graves' disease patients.
- BHV-1400 reduced Gd-IgA1 >60% within hours and 70% within one month in IgA nephropathy, with early eGFR and UPCR improvements.
- Both degrader programs showed well-tolerated safety profiles with no serious adverse events; pivotal Phase 3 trials expected to initiate mid-2026.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0001935979-26-000048
- form_type
- 8-K
- ticker
- BHVN
- cik
- 0001935979
- company_name
- Biohaven Ltd.
- filed_at
- 2026-05-27T21:13:33+00:00
- discovered_at
- 2026-05-27T21:16:00.263705+00:00
- generated_at
- 2026-05-27T21:19:35.305862+00:00
- sec_items
- ["7.01", "9.01"]
- event_type
- other_material
- sentiment
- positive
- materiality_score
- 0.95
- calibrated_materiality_score
- 0.95
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001935979-26-000048
- json_url
- https://secwatch.observer/filing/0001935979-26-000048.json
- markdown_url
- https://secwatch.observer/filing/0001935979-26-000048.md
- text_url
- https://secwatch.observer/filing/0001935979-26-000048.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1935979/000193597926000048/0001935979-26-000048-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1935979/000193597926000048/bhvn-20260526.htm
- generated_by_model
- deepseek-v4-flash:cloud
- review_status
- machine_generated
- human_reviewed
- false
- corrected
- false
- correction_note
- null
- correction_timestamp
- null
- superseded_by
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