Biohaven Stock Price, News & Analysis

Biohaven Pharmaceutical (NYSE: BHVN) announced the FDA's acceptance of its New Drug Application for zavegepant nasal spray, offering a potential acute migraine treatment option. This intranasal formulation, if approved, would deliver ultra-rapid relief in as little as 15 minutes and last for 48 hours. The application is based on two pivotal trials demonstrating zavegepant's efficacy, tolerability, and safety compared to placebo, with a PDUFA goal date set for 1Q2023. Zavegepant may serve as a critical alternative for those unable to take oral medications due to nausea.

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 $11.6 billion. Shareholders will receive $148.50 per share in cash and shares in a new company retaining Biohaven's non-CGRP assets. The acquisition enhances Pfizer's Internal Medicine pipeline, focusing on migraine treatments with high market potential. NURTEC is already the leading migraine therapy in the U.S. The deal includes the purchase of Biohaven's CGRP programs and is expected to close by early 2023, pending approvals.

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.