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.
Rick Ware Racing has partnered with Biohaven's Nurtec® ODT and Nine Line Apparel to honor fallen service members during the Coca-Cola 600 at Charlotte Motor Speedway. This historic initiative sees one NASCAR team representing all four military branches. A commemorative t-shirt will be sold to raise funds for 22 Until None, a non-profit focused on preventing veteran suicides, which number over 8,000 annually. The program includes visits to military bases, offering service members interaction with the team and educational opportunities about migraine treatments.
Biohaven Pharmaceutical (NYSE: BHVN) announced that it has enrolled the first patient in a Phase 2/3 clinical trial for oral zavegepant, aimed at preventing migraines. This milestone has triggered a $100 million payment from Royalty Pharma, which previously funded $150 million for zavegepant's development. The study will involve around 2,900 participants to evaluate two doses of the drug. Biohaven aims to expand its CGRP product line, addressing the needs of those suffering from CGRP-related conditions.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) has priced its public offering of 2,686,409 common shares at $76.00 each, aiming for gross proceeds of approximately $200 million. The offering is expected to close on March 17, 2021, pending customary conditions. An underwriter option is included, allowing for an additional purchase of up to 402,961 shares. Goldman Sachs & Co. LLC acts as the book-running manager. The shares are issued under an effective shelf registration statement on Form S-3.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced a $200 million underwritten public offering of its common shares, with an additional $30 million option for the underwriter. The offering is aimed at enhancing its financial position as it targets neurological diseases with its product portfolio. The shares will be issued under an effective shelf registration statement on Form S-3, with Goldman Sachs & Co. LLC serving as the book-running manager. The offering is subject to market conditions and completion is not guaranteed.
On March 11, 2021, Biohaven announced approval from the UAE Ministry of Health for NURTEC® ODT (rimegepant) to treat acute migraines in adults. This medication is the first CGRP receptor antagonist offered as a fast-acting orally disintegrating tablet, providing relief within an hour and lasting up to two days. The partnership with Genpharm aims to expand access in the UAE, aligning with Biohaven's strategy for global growth. Notably, NURTEC ODT is not intended for migraine prevention. Common side effects include nausea, which occurred in 2% of patients.
Biohaven Pharmaceutical (BHVN) announced that over 50% of participants have been enrolled in the verdiperstat regimen of the HEALEY ALS Platform Trial, aimed at evaluating potential treatments for amyotrophic lateral sclerosis (ALS). Verdiperstat, a selective inhibitor of myeloperoxidase, is being developed for neurodegenerative diseases, including ALS. The trial involves approximately 160 adults, assessing efficacy based on changes in disease severity over 24 weeks. Despite the COVID-19 challenges, enrollment is proceeding efficiently, highlighting collaboration with the ALS research community.
Biohaven Pharmaceutical (NYSE: BHVN) announced that the Israeli Ministry of Health approved NURTEC® ODT (rimegepant) for the acute treatment of migraine in adults, marking its first regulatory approval outside the U.S. This fast-acting, orally disintegrating tablet offers pain relief within one hour and sustained efficacy lasting up to two days. The approval was achieved through a strategic partnership with Medison Pharma, enhancing access for migraine patients in Israel. NURTEC ODT is not indicated for preventive treatment or for patients with severe renal or hepatic impairment.
Biohaven Pharmaceutical (NYSE: BHVN) reported a strong Q4 2020, with net product revenues from NURTEC ODT reaching $35.1 million, a 98% increase from Q3. Full-year revenues totaled $63.6 million following the product's FDA approval in February 2020. Despite pandemic challenges, NURTEC ODT's market growth reflects unmet patient needs in migraine treatment. The company also submitted an EU marketing application for rimegepant for acute and preventive migraine treatment. Full-year net loss was $766.8 million, with R&D expenses of $229 million, while SG&A expenses surged to $462.3 million.
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will host a conference call on March 1, 2021, at 8:30 a.m. ET to discuss its fourth quarter and full year 2020 financial results and recent business developments. Investors can access the call via phone or through the company’s website. Biohaven specializes in innovative therapies for neurological and neuropsychiatric conditions, with an FDA-approved product, NURTEC® (rimegepant), and a promising pipeline targeting migraine, OCD, and more.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) announced promising results for BHV-1200, a hyperimmune globulin mimic developed using its MATE platform, demonstrating its ability to neutralize SARS-CoV-2 and variants B.1.1.7 and B.1.351. Preliminary tests showed significant reduction in viral entry into cells. The development of this COVID-19 treatment has garnered support from the Bill and Melinda Gates Foundation. The CEO expressed excitement about advancing BHV-1200 into clinical trials, highlighting its potential advantages over existing therapies.
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