BHVN Stock Recent News
BHVN LATEST HEADLINES
NEW YORK, NY / ACCESS Newswire / March 4, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Biohaven Ltd. ("Biohaven Ltd.
NEW YORK, NY / ACCESS Newswire / March 4, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Biohaven Ltd. ("Biohaven" or "the Company") (NYSE:BHVN).
On Monday, Biohaven Ltd. BHVN highlighted data from BHV-1300, showing rapid and deep reductions in total IgG for the potential treatment of autoimmune disease.
Optimized subcutaneous administration of BHV-1300 achieved rapid, deep and sustained lowering of IgG, differentiating Biohaven's new small molecule class of degraders from the monoclonal antibody FcRn-targeting competition. Up to 84% reduction of total IgG was observed with a median reduction of 80% after subcutaneous weekly 1000 mg dosing in the ongoing Phase 1 study.
Announced acceptance and Priority Review by the United States Food and Drug Administration (FDA) of the new drug application (NDA) for troriluzole in all-genotype spinocerebellar ataxia; expected Prescription Drug User Fee Act (PDUFA) date in 3Q 2025. Cash, cash equivalents, marketable securities and restricted cash as of December 31, 2024 totaled approximately $489 million.
Following Pfizer's acquisition, Biohaven's valuation surged from $300M at $7/share to over $4B at $42/share under Vlad Coric's leadership. Despite the significant valuation increase, substantial upside remains due to Biohaven's promising later-stage clinical assets with key catalysts expected in 2025. The investment thesis hinges on the potential success of these clinical assets, which could drive further valuation growth.
News of a big and important regulator's move was the electricity that powered Biohaven (BHVN 11.19%) stock to an 11%-plus gain on the second trading day of the week. Its leading investigational drug is now significantly closer to potential approval, and many are feeling bullish about the company.
Biohaven's NDA for Troriluzole in spinocerebellar ataxia was accepted by the FDA with Priority Review, potentially leading to approval in Q3 2025. BHV-7000, a selective Kv7 activator, is being studied for bipolar disorder and MDD, with data expected in 2025. The global major depressive disorder treatment market is expected to reach $14.96 billion by 2032.
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. Troriluzole demonstrated a 50-70% slowing of SCA disease progression on the primary and secondary outcome measures at the 3-year endpoint in a real-world evidence (RWE) study.
Presents progress and new anticipated milestones across portfolio of more than 10 assets and 6 therapeutic areas. Announces multiple advancements across the MoDETM (molecular degraders of extracellular proteins) platform and the next generation TRAPTM (targeted removal of aberrant protein) degraders, including: IgA Nephropathy (IgAN) program: First-in-human dosing with BHV-1400, a next generation TRAP degrader, achieved rapid, deep, and selective lowering of only aberrant galactose-deficient IgA1 (Gd-IgA1), the antibody causing IgA nephropathy, while sparing normal IgA.