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 top-line results from a Phase 3 trial of troriluzole for spinocerebellar ataxia (SCA). The primary endpoint was not met, showing no significant change on the functional scale (p=0.76) in the overall population (N=213). However, post hoc analyses indicated a potential treatment effect in the SCA3 subgroup, with a nominal p-value of 0.053. Additionally, a 58% reduction in falls was observed in the treatment group (p=0.043). Biohaven plans to engage with the FDA regarding these findings.
Pfizer will acquire Biohaven Pharmaceutical, significantly impacting BHVN's market position. In Q1 2022, Biohaven reported a remarkable 182% revenue growth to $123.6 million driven by NURTEC® ODT sales. The company's net product sales guidance for 2022 is $825 - $900 million. NURTEC's EU approval enhances its market scope. However, costs for patient programs increased, affecting net revenue. A net loss of $209.1 million was recorded, lower than the previous year's loss. Biohaven's robust pipeline includes new trials and global expansion plans.
Pfizer has announced its acquisition of Biohaven, the maker of NURTEC® ODT, for approximately
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will hold its first quarter 2022 earnings call on May 11, 2022, at 8:30 a.m. ET. The call will discuss financial results for the quarter ending March 31, 2022, and review recent accomplishments and upcoming milestones. Earnings results will be issued on May 10, 2022, alongside a Form 10-Q filing. Biohaven focuses on innovative therapies for neurological and neuropsychiatric diseases, with FDA-approved Nurtec ODT (rimegepant) for migraine treatment and a robust pipeline across five mechanistic platforms.
Pfizer (NYSE: PFE) and Biohaven (NYSE: BHVN) announced the European Commission's marketing authorization for VYDURA® (rimegepant), the first medication approved for both acute and prophylactic treatment of migraines in adults. VYDURA® is an orally disintegrating tablet that targets a significant unmet need for migraine treatment in the EU, affecting around one in ten people. Clinical studies demonstrate its efficacy in reducing migraine symptoms and the frequency of attacks. The approval covers all 27 EU countries, with local reimbursement to follow.
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.
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.
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