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 (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.
Biohaven Pharmaceutical announced preliminary net product revenue of $136 million for NURTEC ODT in Q3 2021, reflecting a 46% increase from Q2. Over 1 million prescriptions have been filled since launch, with approximately 46,000 unique prescribers. NURTEC ODT is the first medication approved for both acute and preventive migraine treatments, addressing a significant healthcare need for the 40 million migraine sufferers in the U.S. The company highlights its market-leading position with positive feedback from patients and healthcare providers.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced that its investigational drug, verdiperstat, failed to demonstrate efficacy in treating multiple system atrophy (MSA), lacking statistical significance against placebo on primary and secondary measures. Safety data were consistent with earlier trials. The company remains committed to addressing neurodegenerative diseases despite this setback, with ongoing trials for verdiperstat in amyotrophic lateral sclerosis (ALS) expected to complete enrollment by Q4 2021. Full study results will be shared at a scientific meeting.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) presented 17 abstracts at the 2021 International Headache Society – European Headache Federation Joint Congress from September 8-12, 2021. The presentations highlighted data on Nurtec® ODT (rimegepant) and intranasal zavegepant, two migraine treatments. Key findings included the efficacy of rimegepant in reducing monthly migraine days and strong patient preference for rimegepant over previous treatments. The data further demonstrated rimegepant's safety profile in patients with cardiovascular risks and zavegepant's effectiveness in acute migraine treatment.
Biohaven Pharmaceutical (NYSE: BHVN) reported second-quarter 2021 net product revenue of $92.9 million, a remarkable increase from $9.7 million in Q2 2020, attributed to strong demand for NURTEC ODT. This product is now FDA-approved for both acute and preventive migraine treatment, with over 875,000 prescriptions written to date. R&D expenses surged to $77.4 million, up from $42.4 million last year, primarily driven by product development. The net loss for Q2 was $210.6 million, or $3.23 per share. The company has a cash reserve of $368 million as of June 30, 2021, with promising pipeline milestones ahead.
On July 29, 2021, Biohaven Pharmaceuticals (NYSE:BHVN) announced that its medication, Nurtec® ODT (rimegepant), is the official migraine partner of the Big Machine Music City Grand Prix. The race will take place in Nashville on August 8, 2021, with Romain Grosjean driving the No. 51 IndyCar. Nurtec ODT is notable for being the first drug approved by the FDA to both treat and prevent migraine attacks. This partnership aims to raise awareness about migraines and highlight the benefits of Nurtec ODT, which affects nearly 40 million Americans.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will report its second quarter 2021 financial results on August 9, 2021, at 8:30 a.m. ET. The earnings call will provide insights into the quarter ended June 30, 2021, along with a review of recent achievements and future milestones. Biohaven specializes in innovative therapies for neurological and neuropsychiatric diseases, including the FDA-approved NURTEC ODT for migraine treatment. Investors can access the call via phone or webcast through Biohaven's website.
Biohaven Pharmaceutical reported preliminary net product revenue of $93 million for NURTEC ODT in Q2 2021, surpassing expectations. Over 750,000 prescriptions have been filled since launch, showing robust growth. NURTEC ODT, the first dual-therapy migraine medication, is approved for both acute and preventive treatment. CEO Vlad Coric emphasized the medication's significant impact on patient care, while CCO BJ Jones highlighted positive feedback from clinicians and patients. The company anticipates continued growth in the migraine treatment market, benefiting approximately 40 million U.S. migraine sufferers.
Sosei Group Corporation announced the dosing of the first healthy subject with HTL0022562 (BHV3100) in a Phase 1 trial. This double-blind, placebo-controlled study will assess the safety and pharmacokinetics of the drug in 88 participants in the UK, expected to complete in 2022. This milestone marks the 10th drug candidate from Sosei's SBDD platform to enter clinical development. Under its collaboration with Biohaven, Sosei will receive milestone payments and funding for the trial while Biohaven leads future studies.
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