Biohaven Stock Price, News & Analysis

On September 29, 2022, Biohaven Pharmaceutical (NYSE: BHVN) announced results from the HEALEY ALS Platform Trial investigating verdiperstat for amyotrophic lateral sclerosis (ALS). Unfortunately, verdiperstat failed to show statistically significant efficacy compared to placebo in key measures, including disease progression and survival over the 24-week study. Safety analysis was consistent with previous trial data. Biohaven remains dedicated to ALS treatment development despite the disappointing results, with complete findings expected at a future scientific meeting.

Biohaven Pharmaceutical (NYSE: BHVN) announced a record date of September 26, 2022 for the spin-off of its subsidiary, Biohaven Ltd. (SpinCo). The spin-off will encompass Kv7 ion channel activators and other platforms. Shareholders will receive one SpinCo share for every two common shares of Biohaven held. This distribution will take effect on the Distribution Date after shareholder approval on September 29, 2022. Common shares of SpinCo will trade on a "when-issued" basis under the symbol "BHVN WI" starting September 23, 2022.

Biohaven Pharmaceutical reports that nearly 49% of migraine patients discontinued barbiturate prescriptions within six months of starting Nurtec ODT. This study, based on 24,359 patients, indicates a significant reduction in mean monthly barbiturate prescriptions by 31.9% and a decrease in dispensed milligrams by 26.2%. Despite the addiction potential and side effects associated with barbiturates, they remain a common first-line treatment. The findings underscore the potential of Nurtec ODT as an alternative therapy for migraine management.

Biohaven Pharmaceutical, under ticker BHVN, reported Q2 2022 financial results showing a significant rebound in net product revenue from NURTEC ODT, totaling $194 million, a 57% sequential increase. The company faced a net loss of $441.4 million, or $6.21 per share, with adjustments revealing a non-GAAP loss of $271.4 million, or $3.82 per share. The FDA accepted the zavegepant NDA filing for acute migraine treatment, while the company completed antitrust approvals for its acquisition by Pfizer at a valuation of $11.6 billion.

Biohaven Pharmaceutical (NYSE: BHVN) has begun enrollment in a Phase 3 trial for taldefgrobep alfa, targeting Spinal Muscular Atrophy (SMA). The trial aims to assess the drug's efficacy and safety as an adjunctive therapy for patients currently on other SMA treatments. Taldefgrobep works by inhibiting myostatin, which limits muscle growth. Approximately 180 patients will be enrolled in this double-blind study. The company highlights a significant unmet need for effective treatments in SMA, despite existing therapies. For more details, visit SMATrials.com or ClinicalTrials.gov.

Biohaven Pharmaceutical (NYSE: BHVN) and Vigeo Therapeutics announced their entry into the GBM AGILE trial, an adaptive platform study for glioblastoma treatments. This trial, which began in July 2019, aims to rapidly identify effective interventions for patients suffering from this aggressive brain cancer. Troriluzole and VT1021 will be tested in newly diagnosed and recurrent glioblastoma patients, with enrollment starting at Henry Ford Health in Detroit, expanding across over 40 sites in the US and globally. Overall, the trial seeks to optimize treatment outcomes through simultaneous testing of multiple therapies.

Biohaven Pharmaceutical presented new findings at the American Headache Society's annual meeting, showcasing the efficacy and safety of Nurtec ODT and zavegepant for migraine treatment. Key results indicate over 80% of patients using Nurtec ODT reported a ≥50% reduction in migraine frequency, with nearly 50% achieving complete relief. The Phase 3 study of zavegepant nasal spray highlighted its rapid pain relief within 15 minutes, lasting up to 48 hours after administration. These findings reinforce Biohaven's commitment to enhancing migraine care.

Biohaven Pharmaceutical (NYSE: BHVN) presented significant findings at the 64th annual meeting of the American Headache Society (June 9-12, 2022). Highlights include 31 presentations emphasizing Nurtec ODT and zavegepant, showcasing robust efficacy and safety data. Key results indicate over 80% of patients treated with Nurtec ODT experienced a 50% reduction in monthly migraine days, with roughly half achieving complete cessation. The FDA is reviewing a new drug application for zavegepant, furthering Biohaven's position in migraine treatment.

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.