Biohaven Ltd. develops clinical-stage biopharmaceutical programs across immunology, obesity, neuroscience and oncology. News about BHVN commonly centers on pipeline progress for Kv7 ion channel modulation in epilepsy, MoDE™ and TRAP™ extracellular protein degraders for immunological diseases, myostatin-activin pathway agents for neuromuscular and metabolic diseases, and antibody-drug conjugates in cancer.
Company updates also cover clinical trial enrollment and data presentations, scientific conference activity, regulatory interactions, quarterly financial results and capital-raising activity. Recurring program references include opakalim, taldefgrobep alfa, BHV-1300, BHV-1400, BHV-8000, BHV-1510 and BHV-1530.
Biohaven Pharmaceutical (NYSE: BHVN) has begun enrollment in a Phase 3 trial for taldefgrobep alfa, targeting Spinal Muscular Atrophy (SMA). The trial aims to assess the drug's efficacy and safety as an adjunctive therapy for patients currently on other SMA treatments. Taldefgrobep works by inhibiting myostatin, which limits muscle growth. Approximately 180 patients will be enrolled in this double-blind study. The company highlights a significant unmet need for effective treatments in SMA, despite existing therapies. For more details, visit SMATrials.com or ClinicalTrials.gov.
Biohaven Pharmaceutical (NYSE: BHVN) and Vigeo Therapeutics announced their entry into the GBM AGILE trial, an adaptive platform study for glioblastoma treatments. This trial, which began in July 2019, aims to rapidly identify effective interventions for patients suffering from this aggressive brain cancer. Troriluzole and VT1021 will be tested in newly diagnosed and recurrent glioblastoma patients, with enrollment starting at Henry Ford Health in Detroit, expanding across over 40 sites in the US and globally. Overall, the trial seeks to optimize treatment outcomes through simultaneous testing of multiple therapies.
Biohaven Pharmaceutical presented new findings at the American Headache Society's annual meeting, showcasing the efficacy and safety of Nurtec ODT and zavegepant for migraine treatment. Key results indicate over 80% of patients using Nurtec ODT reported a ≥50% reduction in migraine frequency, with nearly 50% achieving complete relief. The Phase 3 study of zavegepant nasal spray highlighted its rapid pain relief within 15 minutes, lasting up to 48 hours after administration. These findings reinforce Biohaven's commitment to enhancing migraine care.
Biohaven Pharmaceutical (NYSE: BHVN) presented significant findings at the 64th annual meeting of the American Headache Society (June 9-12, 2022). Highlights include 31 presentations emphasizing Nurtec ODT and zavegepant, showcasing robust efficacy and safety data. Key results indicate over 80% of patients treated with Nurtec ODT experienced a 50% reduction in monthly migraine days, with roughly half achieving complete cessation. The FDA is reviewing a new drug application for zavegepant, furthering Biohaven's position in migraine treatment.
Biohaven Pharmaceutical (NYSE: BHVN) announced the FDA's acceptance of its New Drug Application for zavegepant nasal spray, offering a potential acute migraine treatment option. This intranasal formulation, if approved, would deliver ultra-rapid relief in as little as 15 minutes and last for 48 hours. The application is based on two pivotal trials demonstrating zavegepant's efficacy, tolerability, and safety compared to placebo, with a PDUFA goal date set for 1Q2023. Zavegepant may serve as a critical alternative for those unable to take oral medications due to nausea.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) reported top-line results from a Phase 3 trial of troriluzole for spinocerebellar ataxia (SCA). The primary endpoint was not met, showing no significant change on the functional scale (p=0.76) in the overall population (N=213). However, post hoc analyses indicated a potential treatment effect in the SCA3 subgroup, with a nominal p-value of 0.053. Additionally, a 58% reduction in falls was observed in the treatment group (p=0.043). Biohaven plans to engage with the FDA regarding these findings.
Pfizer will acquire Biohaven Pharmaceutical, significantly impacting BHVN's market position. In Q1 2022, Biohaven reported a remarkable 182% revenue growth to $123.6 million driven by NURTEC® ODT sales. The company's net product sales guidance for 2022 is $825 - $900 million. NURTEC's EU approval enhances its market scope. However, costs for patient programs increased, affecting net revenue. A net loss of $209.1 million was recorded, lower than the previous year's loss. Biohaven's robust pipeline includes new trials and global expansion plans.
Pfizer has announced its acquisition of Biohaven, the maker of NURTEC® ODT, for approximately $11.6 billion. Shareholders will receive $148.50 per share in cash and shares in a new company retaining Biohaven's non-CGRP assets. The acquisition enhances Pfizer's Internal Medicine pipeline, focusing on migraine treatments with high market potential. NURTEC is already the leading migraine therapy in the U.S. The deal includes the purchase of Biohaven's CGRP programs and is expected to close by early 2023, pending approvals.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will hold its first quarter 2022 earnings call on May 11, 2022, at 8:30 a.m. ET. The call will discuss financial results for the quarter ending March 31, 2022, and review recent accomplishments and upcoming milestones. Earnings results will be issued on May 10, 2022, alongside a Form 10-Q filing. Biohaven focuses on innovative therapies for neurological and neuropsychiatric diseases, with FDA-approved Nurtec ODT (rimegepant) for migraine treatment and a robust pipeline across five mechanistic platforms.
Pfizer (NYSE: PFE) and Biohaven (NYSE: BHVN) announced the European Commission's marketing authorization for VYDURA® (rimegepant), the first medication approved for both acute and prophylactic treatment of migraines in adults. VYDURA® is an orally disintegrating tablet that targets a significant unmet need for migraine treatment in the EU, affecting around one in ten people. Clinical studies demonstrate its efficacy in reducing migraine symptoms and the frequency of attacks. The approval covers all 27 EU countries, with local reimbursement to follow.