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. (NYSE: BHVN) is a clinical-stage biopharmaceutical company whose news flow centers on progress across its immunology, obesity, neuroscience and oncology pipelines. Company updates frequently cover clinical trial readouts, regulatory interactions, financing events and scientific presentations that shape the outlook for its drug development platforms.
Investors and followers of BHVN news can expect detailed announcements on Biohaven’s Kv7 ion channel modulation programs, including opakalim in refractory focal epilepsy and major depressive disorder, as well as updates on the MoDE™ and TRAP™ extracellular degrader platforms targeting immune-mediated diseases such as IgA nephropathy and Graves’ disease. News releases also highlight the advancement of taldefgrobep alfa, a myostatin-activin pathway inhibitor in obesity and SMA, and BHV-8000, a brain-penetrant TYK2/JAK1 inhibitor in pivotal studies for early Parkinson’s disease.
Biohaven’s oncology news often focuses on early clinical data from its next-generation antibody-drug conjugates, including BHV-1510, a Trop2-directed ADC, and BHV-1530, an FGFR3-directed ADC, with reports of tumor responses, safety profiles and combination strategies with checkpoint inhibitors. Additional coverage includes regulatory milestones such as the FDA Complete Response Letter for VYGLXIA (troriluzole) in spinocerebellar ataxia and the company’s stated plans for further regulatory dialogue.
Capital markets and corporate updates—such as public offerings of common shares, at-the-market transactions, portfolio reprioritization and cost-optimization measures—also feature prominently in BHVN news. Readers who monitor this stream gain insight into Biohaven’s evolving clinical strategy, key upcoming milestones and how the company allocates resources across its late-stage programs.
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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.
Biohaven Pharmaceutical (NYSE: BHVN) has initiated a Phase 2/3 clinical trial to evaluate the safety and efficacy of Nurtec® ODT (rimegepant) 75 mg in treating chronic rhinosinusitis (CRS), impacting 5-12% of the population. The trial aims to enroll 200 patients across 25 U.S. sites and will assess changes in facial pain and safety measures. Nurtec ODT is already FDA-approved for migraine treatment. The trial represents a potential new therapeutic option for patients suffering from this condition, addressing a significant unmet medical need in CRS management.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will host its fourth quarter and year-end 2021 earnings call on February 25, 2022, at 8:30 a.m. ET. The call will provide financial results for the quarter ending December 31, 2021, alongside recent accomplishments and upcoming milestones. Biohaven is focusing on innovative therapies for neurological and neuropsychiatric diseases, including FDA-approved NURTEC ODT for migraine treatment and a wide pipeline targeting various conditions. For participation, call 877-407-9120 (domestic) or 412-902-1009 (international).
Biohaven Pharmaceutical and Pfizer announced successful Phase 3 trial results for rimegepant, aimed at treating migraines in 1,431 adults across the Asia-Pacific region. This trial, led by BioShin Limited, confirmed that a single 75 mg dose significantly alleviated migraine symptoms within two hours (p<0.0001) and showed sustained effectiveness for up to 48 hours. Following this success, rimegepant, currently marketed as Nurtec ODT in the U.S., has regulatory applications pending in Europe. The partnership aims to expand the drug's availability, particularly in regions where migraine remains prevalent.