BHVN - Biohaven Ltd.
Biohaven's Clinical Data on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload, Selected for Oral Presentation at the EORT
Oral presentation selected: Phase 1 findings from the ongoing BHV1530-101 study will be featured in an oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), a leading international forum for early-phase oncology drug development. First-in-class FGFR3 ADC: BHV-1530 is a first-in-class potential FGFR3-directed antibody-drug conjugate incorporating Biohaven's proprietary TopoIx payload, that has shown early clinical activity with a differentiated and tolerable safety profile.
Biohaven shares gave up nearly 15% in a single session on September 10, 2026 following the FDA's partial clinical hold on new-patient enrollment in the BHV-7000/opakalim epilepsy trials NEW YORK, Sept. 11, 2026 /PRNewswire/ -- Biohaven Ltd (NYSE: BHVN) dropped $2.21, or about 14.73%, on September 10, 2026 after the Company disclosed that the FDA placed a partial clinical hold on new-patient enrollment in the Company's BHV-7000/opakalim epilepsy trials.
Biohaven says regulators placed a partial hold on a clinical study for its epilepsy drug candidate, opakalim. One rival drugmaker stands to benefit.
Biohaven Ltd. (NYSE:BHVN) on Thursday announced a partial clinical hold issued by the U.S. Food and Drug Administration (FDA) on new patient enrollment for its BHV-7000 program, while maintaining timelines for its lead pivotal study in refractory focal epilepsy.
Biohaven said on Thursday the U.S. FDA had imposed a partial clinical hold, pausing new patient enrollment in trials of its experimental epilepsy drug after rodent findings, sending its shares down more than 13% in premarket trading.
BlackRock Inc. bought a new stake in shares of Biohaven Ltd. (NYSE: BHVN) during the undefined quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The institutional investor bought 13,210,585 shares of the company's stock, valued at approximately $196,574,000. BlackRock Inc. owned approximately 8.77% of
Its partner is South Korean peer SK Biopharmaceuticals. It also secured a victory in a lawsuit.
Biohaven Ltd. maintains a Buy rating, driven by pivotal trial progress in protein degraders and a key licensing deal for its Kv7 platform with SK Biopharmaceuticals. BHVN-1300's phase 3 for Graves' disease is underway; BHV-1400's phase 3 for IgA nephropathy is set to start in H2 2026. Opakalim [BHV-7000] for refractory focal epilepsy is fully enrolled in phase 2/3, with topline data expected in H2 2026 and a $350M upfront SK Biopharmaceuticals deal secured.
Biohaven secures a transformative $795M global licensing deal with SK Biopharmaceuticals for its Kv7 ion channel platform, notably opakalim. This agreement immediately strengthens BHVN's cash position, reduces R&D costs, and extends the funding runway, addressing prior liquidity concerns. I am upgrading BHVN to Buy, citing promising degrader pipeline assets targeting large autoimmune markets and pivotal trial initiations.
Biohaven stock rallies 18% on a $795M out-licensing deal granting SK Biopharmaceuticals global rights to its Kv7 epilepsy platform, led by opakalim.
Biohaven Ltd. (NYSE:BHVN) scored two major wins this week. The company signed a lucrative licensing agreement with SK Biopharmaceuticals Co. Ltd. and secured a legal victory alongside Yale University in a trade-secret dispute.
Biohaven and SK Biopharmaceuticals Enter into Strategic Global Licensing Agreement for Novel Kv7 Ion Channel Platform and Opakalim, Lead Candida
Biohaven has entered into a licensing agreement with South Korean drug maker SK Biopharmaceuticals for Biohaven's epilepsy drug platform, including Opakalim, for up to $795 million, the companies said in a statement on Wednesday.
SK Biopharmaceuticals to provide upfront and milestone payments related to the Kv7 platform up to $795 million, along with tiered royalties to Biohaven ranging from the mid-teens to low twenties on U.S. net sales of opakalim. Opakalim, the lead candidate from Biohaven's Kv7 platform, is a next-generation, selective Kv7.2/7.3 potassium channel activator currently in Phase 2/3 development for focal epilepsy, with topline results from the RISE3 trial expected in 2H 2026.
NEW HAVEN, Conn., Aug. 25, 2026 /PRNewswire/ -- Biohaven Ltd.
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.
Infinitum founder and Groq board director brings frontier AI and technology-investing expertise to Biohaven as the company advances AI-enabled approaches to drug development NEW HAVEN, Conn., Aug. 6, 2026 /PRNewswire/ -- Biohaven Ltd.
NEW HAVEN, Conn., July 27, 2026 /PRNewswire/ -- Biohaven Ltd.
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.