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First extracellular protein degraders in the clinic demonstrate rapid and robust pharmacodynamic effects and compelling safety in nearly 200 individuals dosed, Phase 3 trial underway Positive clinical biomarker and patient data presented from Biohaven's extracellular degrader platform demonstrated deep, rapid, selective lowering of disease-driving antibodies with BHV-1300 in Graves' disease and BHV-1400 IgA Nephropathy, supporting advancement toward multiple registrational programs. Initiated pivotal Phase 3 study for BHV-1300 in Graves' disease with plans to initiate pivotal Phase 3 study for BHV-1400 in IgAN in 2H 2026.
Biohaven also announces new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo®) Early clinical activity observed: Phase 1 dose-escalation data show early tumor reductions in patients with Fibroblast Growth Factor Receptor (FGFR)3-altered and wild-type overexpressing tumors. Signal activity including confirmed partial responses in heavily pretreated patients in multiple tumor types.
Biohaven's pipeline is now more focused after having to narrow down its R&D efforts to other assets. Today, I think opakalim's pivotal epilepsy readout is probably the most important near-term catalyst that could validate their pipeline. They also have interesting, albeit early, positive findings with BHV-1300 and BHV-1400 for their degrader platform.
BHV-1300 is the first MoDE™ extracellular protein degrader to enter a pivotal trial, pioneering a new class of precision immunology medicines that eliminate the disease-driving antibodies at the root of autoimmune disease. BHV-1300 targets the TSHR-IgG1 autoantibody that drives Graves' disease, not the thyroid gland itself.
Biohaven (BHVN) is upgraded from "Hold" to "Buy," driven by FDA regulatory shifts and strong biomarker data for its protein degrader pipeline. The company is set to initiate pivotal studies for BHV-1300 in Graves' Disease and BHV-1400 in IgA Nephropathy in mid-2026, targeting large unmet markets. Phase 1b data show over 80% reduction in pathogenic TSHR-IgG1 for BHV-1300 and over 60% Gd-IgA1 reduction for BHV-1400, with safety advantages over competitors.
BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls Exhibits robust beneficial effects across a spectrum of preclinical models of Alzheimer's, and multiple sclerosis: restores metabolic deficits, reduces inflammation and neurodegeneration, and enhances remyelination PKM2 modulation offers a potential new paradigm for treating large, underserved, and high-value indications in neurology, ophthalmology, and immunology NEW HAVEN, Conn., June 1, 2026 /PRNewswire/ -- Biohaven Ltd.
BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study. Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
Prioritizing three key, late-stage clinical programs including Molecular Degrader of Extracellular Proteins (MoDETM) and Targeted Removal of Aberrant Protein (TRAPTM) extracellular protein degradation for immunological diseases, Kv7 ion channel modulation for epilepsy; and myostatin-activin pathway targeting obesity: Inflammation and Immunology: Graves' Disease: First-in-patient clinical experience with IgG MoDE degrader BHV-1300 resulted in complete suppression of disease-causing TSH receptor-stimulating antibodies, normalization of previously elevated thyroid hormones within weeks after dosing a patient with Graves' disease. BHV-1300 has shown the potential for best-in-class reductions of IgG, with maximum reductions of up to an 87% decrease from baseline within weeks of dosing in a study conducted in healthy volunteers.