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... Read More

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 . Reported positive degrader data with multiple... Read More

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. Troriluzole has a... Read More

Presents progress and new anticipated milestones across portfolio of more than 10 assets and 6 therapeutic areas. Announces multiple advancements across the MoDE TM (molecular degraders of extracellular proteins) platform and the next generation TRAP TM (targeted removal of aberrant protein) degraders, including: IgA... Read More

NEW HAVEN, Conn. , Jan. 7, 2025 /PRNewswire/ -- Biohaven Ltd . (NYSE: BHVN) today announced that Vlad Coric, M.D., Chairman and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference at The Westin St. Francis Hotel in San Francisco, California , on Monday, January 13, 2025 , at 8:15 am (PT) . About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and... Read More

BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60% in the lowest subcutaneous dose tested in the MAD. Subcutaneous BHV-1300 achieved rapid and progressive lowering of IgG within hours of each weekly dose administration, and pharmacodynamic effects were sustained relative to baseline over the four-week... Read More

Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation being evaluated in ongoing Phase 2 and 3 clinical studies, demonstrating excellent tolerability at all doses evaluated without central nervous system (CNS) adverse effects typically associated with other anti-seizure medications (ASMs), such as somnolence and cognitive/mood... Read More

In the RESILIENT SMA study, taldefgrobep alpha showed clinically meaningful improvements in motor function at all timepoints on the Motor Function Measurement-32 scale (MFM-32), but the treatment arm did not statistically separate on the primary outcome at Week 48 compared to the placebo+standard of care (SOC) group. Efficacy... Read More

Cash, cash equivalents, marketable securities and restricted cash as of October 2, 2024 totaled approximately $642 million Achieved positive topline trial results from pivotal trial with troriluzole in spinocerebellar ataxia (SCA) Troriluzole 200 mg QD dosed orally in patients with SCA met the study's primary endpoint on the change from baseline on the modified functional Scale for the Assessment and Rating of Ataxia... Read More

NEW HAVEN, Conn. , Oct. 2, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the closing of its underwritten public offering of 6,052,631 of its common shares, which includes the full exercise of the underwriters' option to... Read More

NEW HAVEN, Conn. , Oct. 1, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN),a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the pricing of its underwritten public offering of 5,263,158 of its common shares at a price to the public of $47.50 per share. In addition,... Read More

NEW HAVEN, Conn. , Sept. 30, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that it has commenced an underwritten public offering of $250 million of its common shares. All of the common shares to be sold in the offering... Read More

Biohaven initiated a pivotal Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine BHV-2100 is a potential first-in-class, potent, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist— a novel, highly selective, and non-opioid investigational treatment being developed for migraine and... Read More

Troriluzole 200 mg dosed orally, once daily, in patients with SCA met the study's primary endpoint on the change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes. Troriluzole also showed statistically significant superiority after both... Read More

Conference call and webcast to be held Monday, September 23 , at 8:30am ET NEW HAVEN, Conn. , Sept. 20, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), today announced that it will host a conference call to discuss topline data from Study BHV4157-206-RWE (NCT06529146), a study designed in discussion with the US Food and Drug Administration (FDA), to assess the effectiveness of troriluzole in Spinocerebellar... Read More

Cash, cash equivalents, marketable securities and restricted cash totaled approximately $440 million on June 30, 2024 Biohaven's Molecular Degrader of Extracellular Proteins (MoDE™) platform advancing multiple new targets and reported positive interim data from its lead investigational drug in an ongoing Phase 1 study of BHV-1300: The Company reported dose-dependent and rapid IgG reductions in its ongoing Phase 1 trial with... Read More

Reports new positive interim data from the ongoing Phase 1 study of BHV-1300, Biohaven's lead investigational drug from its Molecular Degrader of Extracellular Proteins (MoDE™) platform BHV-1300 demonstrates dose-dependent and rapid IgG reductions within hours of administration No SAEs, no severe AEs, most AEs were mild,... Read More

BHV-1510 is a novel trophoblast cell surface antigen-2 (Trop-2) directed antibody drug conjugate (ADC) that has demonstrated a highly differentiated preclinical monotherapy efficacy profile, the potential for broader therapeutic margin than other Trop-2 ADCs currently in development, and synergistic affects when combined with... Read More

Cash, cash equivalents, marketable securities and restricted cash totaled approximately $287.6 million on March 31, 2024 , which excludes the net proceeds of approximately $247.8 million from Biohaven's public offering completed on April 22, 2024 Completed public offering of 6,451,220 Biohaven Ltd. common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the... Read More

NEW HAVEN, Conn. , April 22, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology, today announced the closing of its underwritten public offering of 6,451,220 of its common shares, which includes the full exercise of the underwriters'... Read More

NEW HAVEN, Conn. , April 18, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology, today announced the pricing of its underwritten public offering of 5,609,757 of its common shares at a price to the public of $41.00 per share. In addition,... Read More

NEW HAVEN, Conn. , April 17, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience and oncology, today announced that it has commenced an underwritten public offering of $200 million of its common shares. All of the common shares to be sold in the offering... Read More

Biohaven's first-in-class Molecular Degrader of Extracellular Proteins (MoDE™) technology targeting IgG removal, BHV-1300, was selected for an oral presentation at AAN highlighting its novel mechanism of action and the latest preclinical data demonstrating rapid, robust, and selective target removal Biohaven announces it will present safety and IgG lowering data from its ongoing single ascending dose (SAD) study of BHV-1300... Read More

Driving clinical, regulatory, and operational excellence across five innovative platforms focused on immunology, neuroscience, and oncology: Portfolio targeting large indications including obesity, epilepsy, bipolar disorder, depression, obsessive-compulsive disorder (OCD), migraine, pain, Alzheimer's disease, Parkinson's disease, multiple sclerosis, rheumatoid arthritis, and cancer. Also advancing potential novel treatments... Read More

Five proprietary platforms fueling multiple clinical programs Targeting large indications including epilepsy, bipolar disorder, depression, obsessive-compulsive disorder, migraine, pain, obesity, Alzheimer's disease, Parkinson's disease, multiple sclerosis, rheumatoid arthritis, and cancer. Plus, rare autoimmune and... Read More

NEW HAVEN, Conn. , Jan. 2, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) today announced that Vlad Coric, M.D., Chairman and Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference at The Westin St. Francis Hotel in San Francisco, California , on Monday, January 8, 2024 at 8:15 am (PT). A slide deck of the presentation will be available on the Investors section of the Biohaven website at... Read More

Biohaven reported full results from the BHV-7000 Phase 1 study examining doses up to 120 mg daily, demonstrating BHV-7000 was well-tolerated at all doses studied without the typical central nervous system (CNS) adverse effects associated with other anti-seizure medications (ASMs), such as somnolence and cognitive/mood disturbances. In a Phase 1 electroencephalogram (EEG) biomarker study, BHV-7000 demonstrated dose-dependent... Read More

Cash, cash equivalents, marketable securities and restricted cash totaled approximately $495 million on October 5, 2023 , which included net proceeds of $242 million from completed public offering on October 5, 2023 Completed public offering of 11,761,363 Biohaven Ltd. common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of $22.00 per share... Read More

Taldefgrobep is a novel myostatin inhibitor with the potential to be an important therapy for neuromuscular disorders and metabolic diseases including obesity. Taldefgrobep monotherapy significantly reduced fat and increased lean muscle mass in an obese mouse model; potential body composition changes relevant to individuals... Read More

NEW HAVEN, Conn. , Oct. 5, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the closing of its underwritten public offering of 11,761,363 of its common shares, which includes the full exercise of the underwriters' option to... Read More

NEW HAVEN, Conn. , Oct. 2, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the pricing of its underwritten public offering of 10,227,273 of its common shares at a price to the public of $22.00 per share. In addition,... Read More

NEW HAVEN, Conn. , Oct. 2, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that it has commenced an underwritten public offering of $200 million of its common shares. All of the common shares to be sold in the offering... Read More

Taldefgrobep alfa is the only myostatin inhibitor in clinical development that targets both myostatin and activin A signaling, two key regulators of muscle mass and adipose tissue RESILIENT, the pivotal clinical trial in spinal muscular atrophy, was designed to test the efficacy and safety of taldefgrobep alfa as adjunctive therapy to increase muscle in SMA patients treated with standard of care nusinersen, risdiplam or... Read More

Examination of EEG in healthy subjects administered single doses of BHV-7000 confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications. EEG results demonstrated dose-dependent and time-dependent effects of BHV-7000 on CNS target engagement in study subjects: At the... Read More

Taldefgrobep alfa, in Phase 3 global clinical development for Spinal Muscular Atrophy, granted EU Orphan Drug Designation in addition to previously receiving Fast Track and Orphan Drug Designation in the US NEW HAVEN, Conn. , July 31, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN; "Biohaven") announced today that it received orphan medicinal product designation from the European Commission (EC) for taldefgrobep alfa, a... Read More

Cash, cash equivalents, and marketable securities totaled $349.0 million as of June 30, 2023 Announced positive interim data from BHV-7000 EEG biomarker study demonstrating evidence of central nervous system (CNS) target engagement, confirming previously reported preclinical and clinical data, and highlighting the paradigm-changing potential of BHV-7000 in the treatment of epilepsy and mood disorders Brain penetrant... Read More

NEW HAVEN, Conn. , July 27, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced multiple updates on key programs including: preliminary EEG data from its lead investigational agent, BHV-7000, from... Read More

Submitted a new drug application (NDA) for troriluzole in Spinocerebellar Ataxia Type 3 (SCA3) to U.S. FDA in 2Q2023, marking the team's fourth NDA in approximately 3 years Released additional data from Kv7 platform, including Phase 1 safety data by dose groups for BHV-7000 that further validates differentiated profile Projected Phase 3 Spinal Muscular Atrophy trial to complete enrollment in 2023 Initiated Phase 1 study of... Read More

NEW HAVEN, Conn. , May 25, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating diseases, including ultra-rare disorders, will provide an overview of its platforms and pipeline at an in-person Research and Development (R&D) Day taking place on May 31 in... Read More

Acquired exclusive license for oral, brain-penetrant, dual TYK2/JAK1 inhibitor for immune-mediated brain disorders in March 2023 covering global rights (excluding China ) Appointed Nick Kozauer, M.D. as SVP of Clinical Development and Regulatory Strategy following his tenure as Director of the Division of Neurology 2 in the Office of New Drugs of the U.S. Food and Drug Administration Taldefgrobep alfa granted Fast Track... Read More

NEW HAVEN, Conn. , April 17, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company, today announced that Nick Kozauer, M.D. has joined its executive leadership team as Senior Vice President for Clinical Development and Regulatory Strategy. Dr. Kozauer comes to Biohaven... Read More

Acquired exclusive license for oral, brain-penetrant, dual TYK2/JAK1 inhibitor for immune-mediated brain disorders in March 2023 covering global (ex- China ) rights; Phase 1 clinical trial initiation anticipated in 2023 Completed Phase 1 SAD/MAD study with BHV-7000 from our Kv7 ion channel activator platform and reported preliminary safety and tolerability data Commenced enrollment in pivotal Phase 3 study with our myostatin... Read More

Novel first-in-class, brain-penetrant, dual inhibitor of TYK2/JAK1 offers wide therapeutic index with TYK2 inhibition and high selectivity for JAK1 inhibition without the severely limiting adverse class effects of JAK2/JAK3 inhibitors Exclusive license covers global rights excluding China region Biohaven anticipates initiating Phase 1 clinical development in 2023 NEW HAVEN, Conn. , March 22, 2023 /PRNewswire/ -- Biohaven... Read More

BHV-7000 differs pharmacologically and structurally from other known Kv7 compounds in development BHV-7000 demonstrates potent anti-seizure activity without effects on neurobehavior in preclinical models BHV-7000 CNS side effect profile in Phase 1 compares favorably to anti-seizure medications currently approved and in clinical development NEW HAVEN, Conn. , March 14, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) announced... Read More

NEW HAVEN, Conn. , Jan. 6, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) today announced that Vlad Coric, M.D., Chairman and Chief Executive Officer, will present at the 41 st Annual J.P. Morgan Healthcare Conference at The Westin St. Francis Hotel in San Francisco, California , on Tuesday, January 10, 2023 at 7:30 am (PT) . A slide deck of the presentation will be available on the Investors section of the Biohaven website... Read More