BHVN

Enrollment complete in pivotal Phase 2/3 study evaluating opakalim in focal epilepsy (RISE3); top-line results on track for 2H 2026 Emerging opakalim focal epilepsy and idiopathic generalized epilepsy data presented at recent R&D Day reinforce evidence of target engagement, potential for efficacy, and differentiated tolerability profile In the ongoing focal epilepsy open-label extension (OLE) study, 54% of participants on opakalim 75 mg once-daily achieved a ≥50% reduction in seizure frequency compared to pre-randomization baseline, with a markedly lower incidence of nervous system adverse events compared to approved and investigational ASMs High double-blind completion rates of ~95%, and high rollover rates into the OLE of ~95%, reflect favorable patient experience with opakalim NEW HAVEN, Conn., June 30, 2026 /PRNewswire/ -- Biohaven Ltd.

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.

Biohaven Ltd. shared an R&D presentation today in relation to its epilepsy asset and also updated on its degrader programs. BHVN - spun out of the original Biohaven after its acquisition by Pfizer - also has degrader assets focused on autoimmune diseases. Furthermore, there is a Parkinson's program and Obesity program, and some notable catalysts are arriving this year, e.g., pivotal epilepsy topline data.

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.

In a randomized, placebo-controlled, time-to-event trial in idiopathic generalized epilepsy (IGE), the median time to the second day with a generalized tonic-clonic seizure was 141 days in the opakalim 75 mg once-daily treatment group vs. 47 days in the placebo group, representing a 3-fold prolongation.

Biohaven Ltd. (BHVN) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects.

Biohaven to update clinical, regulatory, and operational progress at annual R&D Day at the upcoming Yale Innovation Summit on May 27, 2026. Advancement of high-value, late-stage priority programs: Pivotal epilepsy program with selective Kv7 ion channel activator, opakalim, with expected topline results in 2H 2026.

Biohaven Ltd. is downgraded from Strong Buy to Hold following the FDA's Complete Response Letter for troriluzole in Spinocerebellar Ataxia. BHVN pivots focus to three late-stage programs: MODE/TRAP degraders [BHV-1400, BHV-1300], Kv7 activator Opakalim, and myostatin-activin inhibitor taldefgrobep alfa for obesity. Taldefgrobep alfa targets obesity with a novel MOA aiming for fat loss, muscle gain, and improved safety versus GLP-1s; phase 2 POC data is expected in 2H 2026.