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.
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.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) published research indicating a significant correlation between migraine-related disability and increased healthcare resource utilization among Americans with episodic migraines. The study revealed that over 25% of participants reported severe disability, leading to higher medical costs. These results, published in the March issue of Headache: The Journal of Head and Face Pain, suggest that targeting severely disabled patients with effective treatments could lower costs and improve patient care.
Biohaven Pharmaceutical (NYSE: BHVN) announced that insurance coverage for Nurtec ODT has reached 96% of commercial lives, totaling approximately 255 million individuals. This achievement, effective April 2022, aims to enhance access for migraine patients. Additionally, the FDA approved a label update for Nurtec ODT, including lactation data, which is significant for breastfeeding mothers. The updated data allows healthcare providers to consider Nurtec ODT as a treatment option for this demographic. Nurtec ODT is the first FDA-approved medication to both treat and prevent migraine attacks in adults.
Biohaven Pharmaceutical announced positive findings on Nurtec® ODT (rimegepant) at the American Association of Neurology 2022 Annual Meeting. A study involving 14,019 migraine patients showed that approximately 41% of opioid users had no opioid prescriptions nine months after starting Nurtec ODT. The study indicated a 40.5% opioid discontinuation rate and a 16.1% decrease in monthly opioid prescriptions. These results suggest Nurtec ODT significantly helps reduce opioid dependency among migraine patients, offering a safer treatment option for their condition.
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Biohaven Pharmaceutical (NYSE: BHVN) announced the publication of a Phase 1 study in Breastfeeding Medicine, evaluating rimegepant’s excretion in the milk of lactating women. The study involved 12 women receiving a 75 mg dose, finding that excretion into milk is 1% of the maternal dose, far below safety thresholds. Results show rimegepant is safe and tolerated, supporting its use for migraine treatment in breastfeeding mothers. This addresses concerns for over 30 million American women affected by migraines, especially post-childbirth.
Biohaven Pharmaceutical (BHVN) announced 13 abstracts at the 2022 AAN annual meeting, showcasing advancements in migraine treatment. Key findings include a significant reduction in opioid prescriptions post-Nurtec ODT treatment and positive Phase 1 results for intranasal zavegepant, indicating its safety at doses up to 40 mg. Additionally, systematic reviews confirmed rimegepant, atogepant, and monoclonal antibodies as effective migraine prevention options. These innovations underscore Biohaven's commitment to improving outcomes for patients with neurological conditions.