Welcome to our dedicated page for Biohaven Ltd. news (Ticker: BHVN), a resource for investors and traders seeking the latest updates and insights on Biohaven Ltd. stock.
Biohaven Ltd. (NYSE: BHVN) is a leading clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of transformative treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Leveraging multiple proprietary drug development platforms, Biohaven is advancing an impressive product pipeline that addresses a variety of diseases, ranging from neuromuscular and metabolic disorders to antibody-drug conjugates for cancer and obsessive-compulsive disorder.
Biohaven's notable product candidates include:
- Glutamate Modulation: Troriluzole, currently in Phase 3 trials for obsessive-compulsive disorder, offers hope for patients with inadequate responses to standard treatments.
- Myostatin Inhibition: Taldefgrobep alfa, in Phase 3 studies for spinal muscular atrophy and being evaluated for obesity treatment, targets muscle growth regulation pathways.
- Ion Channels: BHV-7000, a selective activator of Kv7.2/7.3 potassium channels, is in clinical development for epilepsy and mood disorders.
- Inflammation & Immunology: BHV-1300 and BHV-1310, from the innovative extracellular protein degradation platform, aim to treat autoimmune diseases by lowering IgG levels.
- Oncology: BHV-1510, a Trophoblast Cell Surface Antigen-2 (Trop-2) directed ADC, shows promise in treating select advanced epithelial tumors.
Recent milestones highlighted at the 42nd Annual J.P. Morgan Healthcare Conference and other events include significant progress in these areas and the initiation of pivotal human studies. CEO Dr. Vlad Coric emphasized the company's strong focus on neuroscience, immunology, and oncology, with near-term potential in these fields.
Financial updates reveal solid funding for future advancements, supported by a public offering that raised $230 million. Biohaven's robust clinical and preclinical pipelines are backed by an experienced leadership team and a strong financial foundation, underlining the company's capacity for rapid, efficient drug development.
The company’s leadership in neuroscience was underscored at the 2024 American Academy of Neurology Annual Meeting, featuring multiple presentations on Kv7 ion channel modulation, MoDEs, TRPM3 antagonism, and TYK2/JAK1 inhibition. Looking ahead, Biohaven is poised for a groundbreaking year, with multiple INDs planned and significant clinical data expected across its portfolio.
For more information, visit Biohaven's website.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) reported preliminary net product revenue of approximately $190 million for NURTEC ODT in Q4 2021, totaling $462 million for the full year. NURTEC ODT is the first medication approved for both acute and preventive migraine treatment, revolutionizing the therapy landscape. The CEO emphasized NURTEC ODT's role in improving patient outcomes and reducing migraine disability for the estimated 40 million migraine sufferers in the U.S. The results remain subject to final financial closing procedures.
Biohaven Pharmaceutical (BHVN) and Pfizer (PFE) have finalized a collaboration for the commercialization of migraine treatments rimegepant and zavegepant outside the U.S. The deal includes an upfront payment of $500 million to Biohaven, comprising $150 million in cash and $350 million in equity, giving Pfizer 3% ownership in the company. Biohaven is eligible for up to $740 million in future milestones and retains U.S. market rights. This partnership aims to expand the reach of these migraine therapies to millions globally as Biohaven leads ongoing research.
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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