Welcome to our dedicated page for Biohaven news (Ticker: BHVN), a resource for investors and traders seeking the latest updates and insights on Biohaven stock.
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 Holding Company (BHVN) has begun enrollment for a Phase 3 clinical trial to examine the safety and efficacy of troriluzole in patients with obsessive-compulsive disorder (OCD). The trial involves a 280 mg once-daily dose and aims to enroll approximately 600 patients across both the U.S. and Europe. Previous Phase 2 studies indicated a clinically meaningful effect, despite lacking statistical significance. This trial is crucial as no new OCD treatments have been approved in over two decades, and approximately one-third of OCD patients do not respond to current therapies.
Biohaven Pharmaceutical (NYSE: BHVN) announced positive results from a Phase 3 clinical trial of rimegepant for migraine prevention, published in The Lancet. Rimegepant significantly reduced monthly migraine days compared to placebo, with a noted reduction of −4.3 days over the treatment period. The FDA previously approved rimegepant for acute migraine treatment in February 2020. This represents a breakthrough as it demonstrates the efficacy of rimegepant for both acute and preventive migraine therapy. A supplemental New Drug Application for preventive use is under review with a PDUFA goal date in 2Q2021.
Biohaven Pharmaceuticals (NYSE:BHVN) has partnered with Rick Ware Racing for the 2021 NASCAR Cup Series, featuring Nurtec™ ODT as the primary sponsor for the No. 51 car. Approved by the FDA in February 2020 for acute migraine treatment, Nurtec ODT is the first orally disintegrating tablet in its category. This partnership aims to raise awareness about migraine relief among the nearly 40 million individuals affected in the U.S. The team will also participate in the Military Salutes Program, visiting 50 military bases to support troops who may suffer from migraines.
Biohaven Pharmaceutical (NYSE: BHVN) recently announced a value-based contract with Prime Therapeutics for its migraine treatment, NURTEC ODT (rimegepant), addressing the needs of the 55% of migraine patients who find current treatments inadequate. The contract aims to protect health plans financially from high usage while ensuring that the medication's price aligns with its value. NURTEC ODT, FDA-approved in February 2020, offers quick relief, with effects felt within an hour, catering to a significant unmet need among nearly 40 million U.S. migraine sufferers.
Biohaven Pharmaceutical (BHVN) has announced a new investigator-led clinical trial for a CGRP-receptor antagonist aimed at treating plaque psoriasis, led by Dr. Richard Granstein from Weill Cornell Medicine. This study will measure disease severity and quality of life after 16 weeks of treatment compared to placebo. The trial highlights Biohaven's commitment to exploring CGRP's role in dermatological conditions, enhancing their neuroinnovation portfolio, which includes FDA-approved Nurtec for migraines. The trial's commencement signifies potential expansion into dermatological therapies.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced its partnership with the National Ataxia Foundation (NAF) on November 11, 2020, becoming the first industry member to support the NAF Drug Development Collaborative. This initiative aims to enhance the development of treatments for Ataxia, a group of neurodegenerative diseases without current FDA-approved therapies. Biohaven is actively enrolling participants in a Phase 3 clinical trial for its drug, troriluzole, targeting Spinocerebellar Ataxia.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) reported third-quarter 2020 financial results, highlighting net revenues of $17.7 million for NURTEC ODT, significantly surpassing expectations amid pandemic challenges. The drug has garnered over 220,000 prescriptions in just six months, indicating strong market uptake. The company anticipates NURTEC's annual US market potential to reach $4B to $5B. Recent milestones include FDA acceptance of an sNDA for NURTEC's preventive use, and $60 million raised for BioShin to expand their clinical portfolio in the Asia-Pacific region.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will report its third quarter 2020 financial results on November 9, 2020, at 8:30 a.m. ET. The earnings call will cover results for the quarter ending September 30, 2020, alongside recent accomplishments and future milestones. Participants can join via telephone or the company's website. Biohaven specializes in innovative therapies for neurological and neuropsychiatric diseases, including the FDA-approved NURTEC™ ODT for migraine treatment, with a pipeline targeting various crucial disorders.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for migraine prevention. The PDUFA goal date for the FDA's review is set for 2Q2021. NURTEC ODT, launched in March 2020, is the first orally disintegrating tablet approved for acute migraine treatment and potentially addresses both acute and preventive needs. Clinical trials indicate a significant reduction in monthly migraine days for patients using rimegepant. The drug is expected to offer a convenient alternative to injectable therapies.
Biohaven Pharmaceutical (NYSE: BHVN) announced a successful $60M Series A funding for its Asia-Pacific subsidiary, BioShin Limited. The investment, led by OrbiMed, aims to advance Biohaven's clinical portfolio, including the upcoming Phase 3 study of NURTEC™ ODT for migraine treatment in China and Korea. BioShin also plans to enroll sites for a global trial of troriluzole in Spinocerebellar Ataxia. The funding allows BioShin to operate independently without relying on Biohaven's financial support. Biohaven retains majority ownership of BioShin.