Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

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.

PRNewsWire • Jun 1, 2026

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Disease and IgA Nephropathy

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.

PRNewsWire • May 27, 2026

Biohaven: Despite Today's Gains, I Remain Skeptical

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.

Seeking Alpha • May 27, 2026

Biohaven Reports New Clinical Data in Epilepsy with Opakalim, a Selective Kv7.2/7.3 Activator, Highlighting Seizure Control and Markedly Differentiated Tolerability Profile

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.

PRNewsWire • May 26, 2026

Biohaven Ltd. (BHVN) Upgraded to Buy: Here's Why

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

Zacks Investment Research • May 5, 2026

Biohaven Reports Recent Business Developments and First Quarter 2026 Financial Results

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.

PRNewsWire • May 4, 2026

Biohaven: Downgrade To Hold On Troriluzole Setback And Obesity Data 2nd Half 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.

Seeking Alpha • Apr 15, 2026

Why Biohaven Stock Crushed it on Monday

That pundit flagged the stock as a buy. He also expects it to more than double in price.

The Motley Fool • Apr 13, 2026

Biohaven Stock Down 70% but One Fund's New $6 Million Bet Signals Turnaround Potential

Sarissa Capital Management added 513,184 shares in Biohaven during the fourth quarter. The quarter-end position value increased by $5.79 million as a result of the transaction.

The Motley Fool • Mar 23, 2026

This $8.9 Million Buy Targets a Stock Down 68% With $322 Million in Cash

DAFNA Capital Management bought 720,000 shares of Biohaven in the fourth quarter; the estimated trade size was $8.92 million, based on average prices in the fourth quarter of 2025. Meanwhile, the quarter-end value of the position rose by $7.25 million, reflecting both the share increase and stock price changes during the period.

The Motley Fool • Mar 21, 2026