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 Pharmaceuticals (NYSE:BHVN) has renewed its partnership with Rick Ware Racing for the 2022 NASCAR Cup Series and NTT INDYCAR Series, following a successful inaugural season. Nurtec® ODT (rimegepant), the only FDA-approved medication that treats and prevents migraine attacks, will be featured prominently. CEO Vlad Coric emphasized the partnership's goal to raise awareness about migraines, which affect nearly 40 million Americans. The collaboration also includes military outreach, having supported service members through various visits and initiatives.
Global Coalition for Adaptive Research announced the GBM AGILE trial has screened over 1000 patients, achieving enrollment rates 3 to 4 times higher than traditional studies. Biohaven’s troriluzole and Vigeo’s VT1021 will join the trial, assessing multiple therapies for glioblastoma. The trial's expansion includes sites in Europe and China, with IND approval received for Kazia’s paxalisib. The adaptive design aims for quicker identification of effective treatments and supports rapid drug development.
Biohaven Therapeutics, a subsidiary of Biohaven Pharmaceutical (NYSE: BHVN), has announced an exclusive global licensing agreement with KU Leuven for the development of TRPM3 antagonists aimed at chronic pain disorders. The lead candidate, BHV-2100, has shown promise in preclinical models for pain management without the adverse effects of current therapies. This collaboration enhances Biohaven's pipeline, complementing their existing migraine treatments. KU Leuven will receive upfront payments and royalties, signaling a strong investment in pain management therapies.
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.
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