Biohaven Ltd. - BHVN STOCK NEWS

Biohaven presented expanded safety data for BHV-7000, their novel anti-seizure medication, at the American Epilepsy Society 2024 Annual Meeting. The Phase 1 multiple ascending dose studies demonstrated excellent tolerability of the once-daily extended-release formulation without typical CNS adverse effects associated with other anti-seizure medications.

The drug showed favorable safety at doses up to 120 mg daily for 15 days, exceeding the doses being evaluated in ongoing Phase 2/3 trials (up to 75 mg daily). Studies revealed low rates of CNS-related adverse events, with no somnolence or cognitive disturbances reported. Additional nonclinical data showed BHV-7000's effectiveness in reducing neuronal activity and rescuing current density in KCNQ2 variants.

Biohaven reported mixed results from its RESILIENT SMA study of taldefgrobep alfa. While the treatment showed clinically meaningful improvements in motor function, it did not achieve statistical significance at Week 48 compared to placebo. However, positive results were observed in specific subgroups, particularly among Caucasian patients (87% of study population) and those with measurable baseline myostatin levels. The drug demonstrated significant effects on body composition, including reduced fat mass (p=0.008) and increased lean muscle mass. Based on these results, Biohaven plans to advance taldefgrobep into a Phase 2 obesity study in Q4 2024. The treatment was well-tolerated with no serious adverse events.

Biohaven reported its Q3 2024 financial results and recent business developments. As of October 2, 2024, the company had $642 million in cash and equivalents. Key achievements include positive topline results from a pivotal trial of troriluzole in spinocerebellar ataxia (SCA) and the initiation of a Phase 2 trial for BHV-2100 in acute migraine. Troriluzole met primary and secondary endpoints, showing significant improvements in SCA patients over three years. The company plans to submit an NDA in Q4 2024. Recent public offering raised $269.9 million. R&D expenses increased to $157.6 million, partly due to advancing clinical trials, while net loss widened to $160.3 million. Upcoming milestones include Phase 3 data for taldefgrobep alfa in SMA and continued progress across various programs.

Biohaven (NYSE: BHVN) has successfully closed its underwritten public offering of 6,052,631 common shares, including the full exercise of the underwriters' option to purchase an additional 789,473 shares. The offering was priced at $47.50 per share, resulting in gross proceeds of approximately $287.5 million before deducting underwriting discounts, commissions, and offering expenses.

The company intends to use the net proceeds for general corporate purposes. The offering was managed by joint lead book-running managers J.P. Morgan, Morgan Stanley, Jefferies, and TD Cowen. The shares were issued under an effective shelf registration statement on Form S-3, and the offering was made through a prospectus supplement and accompanying prospectus.

Biohaven (NYSE: BHVN) has announced the pricing of its public offering of 5,263,158 common shares at $47.50 per share. The company expects to raise approximately $250 million in gross proceeds before deducting underwriting discounts and expenses. Biohaven has also granted underwriters a 30-day option to purchase up to an additional 789,473 shares at the public offering price. The offering is set to close on October 2, 2024, subject to customary conditions.

The company plans to use the net proceeds for general corporate purposes. J.P. Morgan, Morgan Stanley, Jefferies, and TD Cowen are acting as joint lead book-running managers for the offering. The shares will be issued under an effective shelf registration statement on Form S-3.

Biohaven (NYSE: BHVN), a global clinical-stage biopharmaceutical company, has announced a proposed public offering of $250 million of its common shares. The company plans to grant the underwriter a 30-day option to purchase up to an additional $37.5 million of common shares. J.P. Morgan and Morgan Stanley are acting as book-running managers for the offering.

Biohaven intends to use the net proceeds for general corporate purposes. The offering is subject to market conditions, and there is no assurance regarding its completion or terms. The shares will be issued under an effective shelf registration statement on Form S-3.

Biohaven (NYSE: BHVN) has initiated a pivotal Phase 2 trial evaluating BHV-2100 for the acute treatment of migraine. BHV-2100 is a potential first-in-class, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist, a novel and non-opioid investigational treatment for migraine and other pain disorders.

The trial is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of two doses (75 mg and 150 mg) of BHV-2100. It will enroll approximately 575 patients across 60 sites in the United States. The study aims to support registration with FDA-accepted coprimary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours.

BHV-2100 demonstrated excellent safety and tolerability in Phase 1 trials, with rapid absorption and sustained concentrations. Biohaven aims to address the unmet needs of migraine patients, including those who do not respond to existing therapies, estimated to be about one-third of the 40 million patients in the US.

Biohaven (NYSE: BHVN) announced positive topline results from a pivotal study of troriluzole in Spinocerebellar Ataxia (SCA). The study met its primary endpoint, showing significant improvement in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) after 3 years of treatment. Key findings include:

- 50-70% slowing of disease progression, representing a 1.5-2.2 year delay over 3 years
- Statistically significant superiority at 1, 2, and 3 years
- Achieved significance on 9 consecutive, prespecified primary and secondary endpoints

Biohaven plans to submit a New Drug Application (NDA) to the FDA in Q4 2024, with potential for priority review due to orphan drug and fast-track designations. If approved, Biohaven aims to commercialize troriluzole for SCA in the US by 2025.

Biohaven (NYSE: BHVN) has announced a conference call and webcast scheduled for Monday, September 23, 2024, at 8:30 a.m. Eastern Time. The purpose of this event is to discuss topline data from Study BHV4157-206-RWE (NCT06529146), which was designed in collaboration with the US Food and Drug Administration (FDA) to evaluate the effectiveness of troriluzole in Spinocerebellar Ataxia.

Interested parties can access the live event through the Investor Relations section of Biohaven's website. For those wishing to participate via telephone, registration is required, after which a dial-in number and unique PIN will be provided for conference call access.