Welcome to our dedicated page for Biohaven news (Ticker: BHVN), a resource for investors and traders seeking the latest updates and insights on Biohaven stock.
Biohaven Ltd. develops clinical-stage biopharmaceutical programs across immunology, obesity, neuroscience and oncology. News about BHVN commonly centers on pipeline progress for Kv7 ion channel modulation in epilepsy, MoDE™ and TRAP™ extracellular protein degraders for immunological diseases, myostatin-activin pathway agents for neuromuscular and metabolic diseases, and antibody-drug conjugates in cancer.
Company updates also cover clinical trial enrollment and data presentations, scientific conference activity, regulatory interactions, quarterly financial results and capital-raising activity. Recurring program references include opakalim, taldefgrobep alfa, BHV-1300, BHV-1400, BHV-8000, BHV-1510 and BHV-1530.
Biohaven (NYSE:BHVN) began first-in-human dosing of BHV-8100, an oral, brain-penetrant PKM2 modulator targeting metabolic restoration and immunomodulation. The ongoing Phase 1 study in healthy participants shows preliminary pharmacokinetics consistent with convenient once-daily dosing and a well tolerated profile at projected therapeutic exposures.
Preclinical BrainEx data in ex-vivo human brains demonstrated excellent blood-brain barrier penetration, up to 3-fold improvement in cerebral glucose utilization and lactate production, and preferential metabolic rescue in Alzheimer's disease donor brains versus controls, supporting development across neurodegenerative, neuroinflammatory and retinal disease indications.
Biohaven (NYSE:BHVN) reported Phase 1b patient data for its extracellular degraders BHV-1300 in Graves' disease and BHV-1400 in IgA nephropathy.
BHV-1300 cut TSHR-IgG1 by >80% at 12 weeks with median T4/T3 normalization in 3/5 weeks. BHV-1400 reduced Gd-IgA1 >60% within 48 hours and 70% within one month, with associated eGFR, UPCR and hematuria improvements; both showed mild, self-resolving AEs and no serious events. Pivotal Phase 3 trials are planned by mid-2026 using autoinjectors.
Biohaven (NYSE:BHVN) reported new clinical data for opakalim, a selective Kv7.2/7.3 activator in epilepsy. In idiopathic generalized epilepsy, median time to second generalized tonic-clonic seizure was 141 days on opakalim vs 47 on placebo. In focal epilepsy, 54% achieved ≥50% seizure reduction over six months. Across >1000 subjects, opakalim showed low central nervous system adverse event rates and was well tolerated. A KCNQ2-DEE compassionate-use case showed clinical stability and 50% seizure-count reduction at six months. Top-line Phase 2/3 focal epilepsy results are expected in 2H 2026.
Biohaven (NYSE: BHVN) reported Q1 2026 results and program updates on May 4, 2026. Cash and equivalents totaled approximately $351.8M as of March 31, 2026. Q1 R&D expense was $103.8M and net loss was $130.5M ($0.88/share). Multiple pivotal trial initiations and topline readouts are expected in 2H 2026.
Key near-term milestones include pivotal starts for BHV-1400 (IgAN) and BHV-1300 (Graves') mid-year, and topline results for opakalim (epilepsy) and taldefgrobep alfa (obesity) in 2H 2026.
Biohaven (NYSE: BHVN) completed enrollment in a Phase 2 randomized, double-blind, placebo-controlled study of taldefgrobep alfa in adults with overweight and obesity, targeting ~150 randomized participants across 20 US sites. Topline data are expected in 2H 2026.
The 24-week double-blind period evaluates percent change in total body weight (primary) and body fat and lean mass (secondary); an additional 24-week open-label extension follows.
Biohaven (NYSE: BHVN) reported 4Q and full‑year 2025 results and highlighted clinical and corporate progress. Key clinical highlights include BHV-1300 IgG reductions up to 87%, BHV-1400 Gd‑IgA1 reductions up to 81%, and opakalim OLE seizure reductions ≥50% in most participants. Cash and equivalents totaled $322.0M at Dec 31, 2025, with an additional $178.9M raised via 17.2M shares sold in 2026. The company announced a restructuring to target a ~60% reduction in annual direct R&D spend while accelerating pivotal trials for degraders and opakalim in 2026.
Biohaven (NYSE: BHVN) highlighted early clinical progress across multiple programs at the 44th Annual J.P. Morgan Healthcare Conference on Jan 12, 2026. Key clinical observations include rapid, selective lowering of pathogenic Gd-IgA1 (>60% mean reduction within hours; max >80%) with BHV-1400 and associated hematuria resolution, >60% proteinuria reduction and a 24% eGFR increase in one patient. BHV-1300 produced up to an 87% IgG reduction and suppression of pathogenic TSHR antibodies with thyroid hormone normalization. Opakalim showed a 55% ≥50% responder rate at 75 mg in the OLE. Multiple pivotal studies and topline readouts are anticipated in 2026.
Biohaven (NYSE: BHVN) announced that Vlad Coric, M.D., Chairman and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 a.m. PST (11:15 a.m. EST). The presentation is scheduled for The Westin St. Francis Hotel in San Francisco, California.
Biohaven (NYSE: BHVN) reported results from a Phase 2 proof-of-concept study of BHV-7000 in major depressive disorder (MDD) on Dec. 24, 2025. The study did not meet its primary endpoint (change in MADRS over six weeks versus placebo). Trends favoring BHV-7000 were observed in some clinically relevant subgroups, including participants with more severe depression at screening and baseline. Overall safety was acceptable: adverse events were mostly mild or moderate and largely resolved, with headache (10.7% vs 9.9%) and nausea (4.2% vs 5.6%) as the only events >5% in any arm. Additional analyses are ongoing and Biohaven will present updates at the J.P. Morgan Healthcare Conference in Jan 2026. The company does not plan additional psychiatric trials in 2026 to prioritize immunology, obesity, and epilepsy programs.
Biohaven (NYSE: BHVN) presented Phase 1 data for BHV-1510, a next‑generation Trop2 antibody‑drug conjugate, in combination with Regeneron’s anti‑PD‑1 cemiplimab at ESMO IO (Dec 10–12, 2025).
At the 2.5 mg/kg Q3W BHV‑1510 dose, confirmed objective response rate (ORR) was 72.7% with confirmed responses including 3/5 NSCLC (60%), 4/4 endometrial cancer (100%, including a CR) and 1/2 urothelial (50%). Across 23 efficacy‑evaluable participants the confirmed ORR was 52.2%. Median time to response was 11.1 weeks. Safety showed low rates of payload‑related toxicities, no interstitial lung disease, no treatment discontinuations for AEs, and a favorable PK with unconjugated payload payload‑to‑ADC molar ratio <1%.