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 (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.
Biohaven Pharmaceutical (BHVN) announced its fourth-quarter and full-year 2021 financial results, revealing a transformative year with $463 million in net revenue from NURTEC ODT. The company signed a $1.2 billion global commercialization agreement with Pfizer for rimegepant and zavegepant, propelling NURTEC ODT to market leadership. Q4 revenue reached $190 million, marking a 441% increase year-over-year. Despite significant growth, Biohaven incurred a net loss of $199.2 million. The company anticipates continued momentum in 2022 with multiple product developments and market expansions.
Biohaven and Pfizer have received a positive opinion from the CHMP for rimegepant, a new treatment for migraines, recommending its 75 mg dose for both acute and preventive use in adults. This marks a significant advancement, as rimegepant is set to become the first oral CGRP receptor antagonist in the EU under the trade name VYDURA™, pending European Commission approval. The CHMP's recommendation was based on results from multiple Phase 3 studies that demonstrated rimegepant's safety and efficacy in treating migraines, addressing a crucial unmet need for patients.
Biohaven Pharmaceutical (NYSE: BHVN) announced its acquisition of Channel Biosciences, enhancing its neuroscience portfolio with the Kv7 channel targeting platform. The lead asset, BHV-7000, aims to address epilepsy, a condition affecting over 3.5 million Americans. The deal involves an upfront payment of $65 million in shares and $35 million in cash, along with potential earnouts up to $1.2 billion based on developmental and sales milestones. This strategic move aims to leverage Biohaven's commercial capabilities and deliver innovative treatment options for patients with epilepsy.
Biohaven Pharmaceutical announced a worldwide licensing agreement with Bristol Myers Squibb for the development of taldefgrobep alfa, a Phase 3-ready anti-myostatin adnectin targeted at treating Spinal Muscular Atrophy (SMA). This is Biohaven's third license from Bristol Myers Squibb, with the trial expected to commence in 2022. Taldefgrobep aims to enhance muscle mass and strength in patients with neuromuscular diseases, representing a potential breakthrough in treatment strategies. The agreement includes milestone payments and sales-based royalties for Bristol Myers Squibb.