Biohaven Ltd. - BHVN STOCK NEWS

Biohaven Pharmaceutical (BHVN) announced its fourth-quarter and full-year 2021 financial results, revealing a transformative year with $463 million in net revenue from NURTEC ODT. The company signed a $1.2 billion global commercialization agreement with Pfizer for rimegepant and zavegepant, propelling NURTEC ODT to market leadership. Q4 revenue reached $190 million, marking a 441% increase year-over-year. Despite significant growth, Biohaven incurred a net loss of $199.2 million. The company anticipates continued momentum in 2022 with multiple product developments and market expansions.

Biohaven and Pfizer have received a positive opinion from the CHMP for rimegepant, a new treatment for migraines, recommending its 75 mg dose for both acute and preventive use in adults. This marks a significant advancement, as rimegepant is set to become the first oral CGRP receptor antagonist in the EU under the trade name VYDURA™, pending European Commission approval. The CHMP's recommendation was based on results from multiple Phase 3 studies that demonstrated rimegepant's safety and efficacy in treating migraines, addressing a crucial unmet need for patients.

Biohaven Pharmaceutical (NYSE: BHVN) announced its acquisition of Channel Biosciences, enhancing its neuroscience portfolio with the Kv7 channel targeting platform. The lead asset, BHV-7000, aims to address epilepsy, a condition affecting over 3.5 million Americans. The deal involves an upfront payment of $65 million in shares and $35 million in cash, along with potential earnouts up to $1.2 billion based on developmental and sales milestones. This strategic move aims to leverage Biohaven's commercial capabilities and deliver innovative treatment options for patients with epilepsy.

Biohaven Pharmaceutical announced a worldwide licensing agreement with Bristol Myers Squibb for the development of taldefgrobep alfa, a Phase 3-ready anti-myostatin adnectin targeted at treating Spinal Muscular Atrophy (SMA). This is Biohaven's third license from Bristol Myers Squibb, with the trial expected to commence in 2022. Taldefgrobep aims to enhance muscle mass and strength in patients with neuromuscular diseases, representing a potential breakthrough in treatment strategies. The agreement includes milestone payments and sales-based royalties for Bristol Myers Squibb.

Biohaven Pharmaceutical (NYSE: BHVN) has initiated a Phase 2/3 clinical trial to evaluate the safety and efficacy of Nurtec® ODT (rimegepant) 75 mg in treating chronic rhinosinusitis (CRS), impacting 5-12% of the population. The trial aims to enroll 200 patients across 25 U.S. sites and will assess changes in facial pain and safety measures. Nurtec ODT is already FDA-approved for migraine treatment. The trial represents a potential new therapeutic option for patients suffering from this condition, addressing a significant unmet medical need in CRS management.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) will host its fourth quarter and year-end 2021 earnings call on February 25, 2022, at 8:30 a.m. ET. The call will provide financial results for the quarter ending December 31, 2021, alongside recent accomplishments and upcoming milestones. Biohaven is focusing on innovative therapies for neurological and neuropsychiatric diseases, including FDA-approved NURTEC ODT for migraine treatment and a wide pipeline targeting various conditions. For participation, call 877-407-9120 (domestic) or 412-902-1009 (international).

Biohaven Pharmaceutical and Pfizer announced successful Phase 3 trial results for rimegepant, aimed at treating migraines in 1,431 adults across the Asia-Pacific region. This trial, led by BioShin Limited, confirmed that a single 75 mg dose significantly alleviated migraine symptoms within two hours (p<0.0001) and showed sustained effectiveness for up to 48 hours. Following this success, rimegepant, currently marketed as Nurtec ODT in the U.S., has regulatory applications pending in Europe. The partnership aims to expand the drug's availability, particularly in regions where migraine remains prevalent.

Biohaven Pharmaceuticals partners with Hardware LDN at New York Fashion Week to raise awareness about migraines, affecting nearly 40 million Americans. Designer Jessica Horwell showcases a new collection featuring a classic bomber jacket promoting the word "Fearless," while four models living with migraine walk the runway. Biohaven highlights its migraine treatment, Nurtec ODT, effective in managing symptoms. The collaboration aims to empower women to advocate for better treatment options and supports public awareness regarding the impact of migraines.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) published findings in Cephalalgia Reports indicating that the long-term treatment of migraines with rimegepant 75 mg significantly reduced migraine frequency. The study involved 1,044 patients undergoing a 52-week Open Label Safety Study (BHV3000-201). Results showed a greater reduction in monthly migraine days (MMD) as patients continued with treatment, particularly in those with lower baseline MMD. The acute treatment, first FDA-approved in February 2020, highlights rimegepant's potential both for immediate relief and long-term therapeutic benefits.