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 reported preliminary net product revenue of $93 million for NURTEC ODT in Q2 2021, surpassing expectations. Over 750,000 prescriptions have been filled since launch, showing robust growth. NURTEC ODT, the first dual-therapy migraine medication, is approved for both acute and preventive treatment. CEO Vlad Coric emphasized the medication's significant impact on patient care, while CCO BJ Jones highlighted positive feedback from clinicians and patients. The company anticipates continued growth in the migraine treatment market, benefiting approximately 40 million U.S. migraine sufferers.
Sosei Group Corporation announced the dosing of the first healthy subject with HTL0022562 (BHV3100) in a Phase 1 trial. This double-blind, placebo-controlled study will assess the safety and pharmacokinetics of the drug in 88 participants in the UK, expected to complete in 2022. This milestone marks the 10th drug candidate from Sosei's SBDD platform to enter clinical development. Under its collaboration with Biohaven, Sosei will receive milestone payments and funding for the trial while Biohaven leads future studies.
Biohaven Pharmaceutical (NYSE: BHVN) announces the appointment of Kishen Mehta to its Board of Directors. Mehta, a Portfolio Manager at Suvretta Capital, brings 15 years of experience in the financial industry and previously served as a strategic advisor to Biohaven. His expertise will support the company’s goal of becoming a leading biopharmaceutical entity. Biohaven continues to expand its CGRP migraine franchise and advance late-stage programs targeting neurological diseases. The company’s innovative portfolio includes FDA-approved NURTEC® ODT.
Biohaven Pharmaceuticals (NYSE: BHVN) celebrated the FDA approval of its migraine treatment by ringing the opening bell at the New York Stock Exchange on June 8, 2021. This event coincided with Migraine and Headache Awareness Month, highlighting the significance of their breakthrough medication, which is the first and only approved solution for treating and preventing migraines. The company aims to support the migraine community, reflecting its commitment to addressing this prevalent health issue.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) announced its participation in the 63rd Annual Scientific Meeting of the American Headache Society from June 3-6, 2021, showcasing 19 abstracts including a late-breaking presentation on Nurtec ODT (rimegepant). The FDA approved Nurtec ODT for preventive migraine treatment on May 27. Clinical data presented indicate a significant reduction in monthly migraine days and improved quality of life for patients, especially those who failed prior treatments. Additionally, a Phase 2/3 study of intranasal zavegepant demonstrated promising results for acute migraine treatment.
Biohaven Pharmaceutical announced the FDA approval of NURTEC® ODT (rimegepant 75 mg) for the preventive treatment of migraine, marking it as the first oral CGRP antagonist to receive such approval. This new label allows for up to 18 doses per month, offering both acute and preventive therapy. The approval significantly expands the market potential for NURTEC ODT, benefiting the approximately 95% of U.S. migraine patients with fewer than 15 headache days monthly. The medication's novel formulation provides flexible treatment options, covering a substantial unmet need in migraine care.
Biohaven Pharmaceuticals (NYSE:BHVN) announced that Nurtec® ODT (rimegepant) will be the primary partner for the Rick Ware Racing No. 51 NTT IndyCar Series program. This partnership aims to raise awareness for migraines, affecting nearly 40 million Americans. With Romain Grosjean as the driver, Nurtec ODT's branding will be showcased throughout the racing season. The company emphasizes the significance of addressing migraines, a debilitating condition, through strategic partnerships. Biohaven's commitment to innovation in migraine treatment is highlighted as they expand their outreach.
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Biohaven Pharmaceutical (BHVN) reported first-quarter 2021 results, achieving net revenues of $43.8 million from NURTEC ODT, exceeding expectations. This figure marks a substantial increase from $1.2 million in Q1 2020. Despite a net loss of $261 million, the company highlighted significant advancements in its product pipeline, including progress on verdiperstat and zavegepant. The company aims to maintain momentum in the commercial growth of NURTEC ODT while pursuing regulatory submissions for new treatments.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will hold its first quarter 2021 earnings call on May 10, 2021, at 8:30 a.m. ET. This call will detail financial results for the quarter ending March 31, 2021, and review recent achievements and upcoming milestones. Biohaven specializes in innovative therapies for neurological and neuropsychiatric diseases, boasting FDA-approved NURTEC® ODT for migraine treatment and a promising pipeline targeting multiple conditions.