Welcome to our dedicated page for Biohaven news (Ticker: BHVN), a resource for investors and traders seeking the latest updates and insights on Biohaven stock.
Biohaven Ltd (NYSE: BHVN) is a clinical-stage biopharmaceutical company pioneering innovative therapies in immunology, neuroscience, and oncology. This page provides real-time access to official press releases, financial disclosures, and progress updates on Biohaven’s cutting-edge platforms like the MoDE protein degradation technology and TRAP degraders.
Investors and industry professionals will find curated updates on clinical trial milestones, regulatory submissions, and strategic partnerships. Key content includes earnings reports, FDA communications, and advancements in autoimmune disease treatments, neurological disorder therapies, and oncology programs.
Bookmark this page for direct access to Biohaven’s verified announcements, ensuring you stay informed about developments impacting the company’s scientific and financial trajectory. Regular updates provide critical insights for evaluating Biohaven’s position in competitive therapeutic markets.
Biohaven Pharmaceutical Holding Company (NYSE: BHVN) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for migraine prevention. The PDUFA goal date for the FDA's review is set for 2Q2021. NURTEC ODT, launched in March 2020, is the first orally disintegrating tablet approved for acute migraine treatment and potentially addresses both acute and preventive needs. Clinical trials indicate a significant reduction in monthly migraine days for patients using rimegepant. The drug is expected to offer a convenient alternative to injectable therapies.
Biohaven Pharmaceutical (NYSE: BHVN) announced a successful $60M Series A funding for its Asia-Pacific subsidiary, BioShin Limited. The investment, led by OrbiMed, aims to advance Biohaven's clinical portfolio, including the upcoming Phase 3 study of NURTEC™ ODT for migraine treatment in China and Korea. BioShin also plans to enroll sites for a global trial of troriluzole in Spinocerebellar Ataxia. The funding allows BioShin to operate independently without relying on Biohaven's financial support. Biohaven retains majority ownership of BioShin.
Biohaven Pharmaceutical (BHVN) announced FDA authorization to initiate clinical trials for oral zavegepant (BHV-3500) and achieved first-in-human dosing in a Phase 1 trial. The company secured up to $250 million in funding to advance its CGRP receptor antagonist program, which includes both intranasal and oral formulations for migraine and non-migraine indications. Intranasal zavegepant showed superior efficacy over placebo in earlier trials for migraine treatment. This advances Biohaven's portfolio aimed at neurological disorders.
Biohaven Pharmaceutical (NYSE: BHVN) reported a net loss of $180.9 million for Q2 2020, equating to $3.08 per share, a slight improvement from the previous year's loss of $211.1 million. The company achieved net product revenues of $9.7 million from NURTEC ODT, showing strong prescription growth driven by effective virtual engagement strategies during the COVID-19 pandemic. Biohaven secured a $500 million non-dilutive credit facility and announced a $450 million funding agreement with Royalty Pharma to support its pipeline developments while maintaining a robust cash position of $263.9 million.
Biohaven Pharmaceutical (NYSE: BHVN) has secured a $500 million non-dilutive term loan from Sixth Street to support the commercialization of NURTEC ODT and for general corporate purposes. The terms allow for $375 million to be accessed immediately, with an additional $125 million contingent on achieving $45 million in net sales of NURTEC ODT in early 2021. CEO Vlad Coric emphasized the confidence in their growth following the launch of NURTEC ODT, while Sixth Street noted the shifting landscape of CGRP-targeting migraine therapies.
Biohaven Pharmaceutical (NYSE: BHVN) will report its second quarter 2020 financial results on August 10, 2020, at 8:00 a.m. ET. The earnings call will review the company's recent accomplishments and anticipated milestones, including its innovative therapies targeting neurological and neuropsychiatric diseases. Biohaven is known for its FDA-approved treatment, NURTEC™ ODT, for migraines and has a broad pipeline focused on various conditions. Interested parties can access the call via phone or through the company's website.
Biohaven Pharmaceutical announced the enrollment of the first patients in the HEALEY ALS Platform Trial, aimed at evaluating the efficacy of three treatments, including verdiperstat, for amyotrophic lateral sclerosis (ALS). Verdiperstat is a potential first-in-class inhibitor of myeloperoxidase, targeting neurodegenerative diseases. The trial involves around 160 ALS patients, with a primary focus on the change in disease severity over 24 weeks. Biohaven's ongoing development of verdiperstat addresses the urgent need for effective ALS treatments.
Biohaven Pharmaceutical (BHVN) has announced the completion of enrollment in its Phase 3 M-STAR study, evaluating the safety and efficacy of verdiperstat for multiple system atrophy (MSA). The trial aims to include approximately 300 patients across 50 sites in the US and Europe, assessing disease progression over 48 weeks. Verdiperstat, which has received Orphan Drug and Fast Track designations from the FDA, is positioned as a potential first-in-class treatment targeting neuroinflammation. Topline data is expected by the end of 2021.
Khloé Kardashian partners with Biohaven Pharmaceuticals to launch the Take Back Today campaign aimed at empowering migraine sufferers to share their experiences and learn about effective management options. Having battled migraines for over 20 years, Khloé highlights her personal struggles and use of NURTEC™ ODT, a fast-acting treatment. The campaign seeks to raise awareness about the debilitating nature of migraines, affecting nearly 40 million people, and encourage community support. CEO Vlad Coric emphasizes the commitment to improving patients' lives through innovative therapies like NURTEC ODT.
On June 16, 2020, Biohaven Pharmaceuticals (NYSE: BHVN) presented 25 abstracts on the efficacy, safety, and economic benefits of NURTEC™ (rimegepant) at the AHS Virtual Annual Scientific Meeting. This data underscores NURTEC’s rapid efficacy and safety, particularly for patients with cardiovascular risks. NURTEC ODT is the first CGRP receptor antagonist in an orally disintegrating tablet approved for acute migraine treatment. The presentation included significant findings from Phase 3 trials, emphasizing its tolerability and low rescue medication usage.