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.
Biohaven Pharmaceutical (BHVN) announced that NURTEC ODT (rimegepant) 75 mg received approval from Israel's Ministry of Health for the preventive treatment of episodic migraine in adults. This marks the first global approval outside the U.S. for NURTEC ODT's preventive use. CEO Vlad Coric highlighted the significance of this approval in providing access to a novel, non-injectable treatment. Additionally, Biohaven entered a strategic collaboration with Pfizer for the global commercialization of rimegepant, enhancing its market reach.
Biohaven Pharmaceutical (NYSE: BHVN) announced positive results from its pivotal Phase 3 trial (NCT04571060) for its migraine treatment, intranasal zavegepant. The study met its co-primary endpoints: 24% pain freedom and 40% freedom from bothersome symptoms at 2 hours, showing significant efficacy compared to placebo across 15 measures. Zavegepant relieved pain as early as 15 minutes and enabled normal function by 30 minutes. Biohaven plans to submit a New Drug Application in 1Q 2022, potentially positioning zavegepant as the first intranasal CGRP receptor antagonist for migraines.
Biohaven Pharmaceutical (NYSE: BHVN) appointed Vlad Coric, MD as Chairman of the Board and Matthew Buten as Chief Financial Officer, effective immediately and December 20, 2021, respectively. The leadership transition follows the retirement of Declan Doogan and James Engelhart, who will serve as advisors. Buten, with over 20 years of healthcare investment experience, expressed enthusiasm for advancing Biohaven's portfolio, including the successful Nurtec ODT. The retirements were not due to disagreements regarding company operations.
Biohaven Pharmaceutical (BHVN) announced that its migraine treatment, NURTEC® ODT (rimegepant), was approved by the Kuwait Ministry of Health for acute treatment in adults. This marks a significant expansion, as NURTEC ODT is the first CGRP receptor antagonist available in a fast-acting orally disintegrating tablet form. The company aims to leverage a new strategic partnership with Pfizer to enhance global access to this medication, already approved in other Middle Eastern countries including Israel and the UAE. NURTEC ODT provides pain relief within an hour and lasts up to two days.
Biohaven Pharmaceutical (NYSE: BHVN) announced on November 15, 2021, that it has completed enrollment in the verdiperstat arm of the HEALEY ALS Platform Trial, the first-ever platform trial for Amyotrophic Lateral Sclerosis (ALS). The trial, which began in July 2020, aims to test multiple investigational treatments. About 160 adults with ALS were enrolled to receive either the treatment or a placebo for 24 weeks, with results expected in mid-2022. Verdiperstat is a potential disease-modifying therapy that could provide new treatment options for ALS patients.
Biohaven and Pfizer announced a strategic collaboration for the commercialization of rimegepant outside the U.S. Rimegepant, known as Nurtec® ODT in the U.S., is indicated for both acute and preventive migraine treatment. Pfizer will pay $500 million upfront, with $350 million in equity purchase at a 25% premium, and may provide up to $740 million in milestones. Biohaven will retain responsibility for further development while Pfizer will handle commercialization globally, excluding the U.S. This partnership aims to enhance access to innovative migraine treatments worldwide.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) reported impressive Q3 2021 results, with net product revenues of $135.7 million, a 46% increase from Q2, driven by strong demand for NURTEC ODT, exceeding expectations. With over 1.1 million prescriptions and a partnership with Pfizer for global commercialization, the company sees substantial growth potential in the migraine market, estimated at $4-5 billion annually in the US. However, R&D and SG&A expenses rose significantly, leading to a net loss of $171.8 million. Upcoming milestones include advancing NURTEC ODT and reporting key trial results in 2022.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will host its third quarter 2021 earnings call on November 9, 2021, at 8:00 a.m. ET, where it will report financial results for the quarter ending September 30, 2021. The call will highlight recent achievements and upcoming milestones. Investors can access the call via phone or through the company's website. Biohaven focuses on innovative treatments for neurological and neuropsychiatric conditions, with notable products including FDA-approved NURTEC ODT for migraine management.
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Biohaven Pharmaceutical (NYSE: BHVN) has commenced a Phase 1a/1b clinical trial for BHV-1100, targeting multiple myeloma in patients with minimal residual disease (MRD+). The trial aims to evaluate the safety and efficacy of BHV-1100 combined with autologous cytokine induced memory-like (CIML) natural killer (NK) cells. Enrollment is set for 25 patients prior to autologous stem cell transplant (ASCT). The ARM platform driving BHV-1100 offers potential advantages over traditional therapies, with expectations of significant tumor burden reduction in CD38-positive myeloma cases.