Biohaven Ltd. - BHVN STOCK NEWS

Biohaven Ltd. (NYSE: BHVN) announced the appointment of Nick Kozauer, M.D. as Senior Vice President for Clinical Development and Regulatory Strategy. Dr. Kozauer, formerly at the FDA, directed the Division of Neurology 2, overseeing drug applications for various neurological conditions. His extensive experience includes the approval of over 15 drugs, enhancing Biohaven's potential to advance its pipeline targeting diseases with significant unmet needs. CEO Vlad Coric emphasized that Dr. Kozauer's expertise will strengthen Biohaven’s ability to innovate in neuroscience therapeutics. Biohaven's portfolio includes therapies for rare and debilitating neurological disorders, leveraging advanced drug development capabilities. This executive addition signifies Biohaven's commitment to enhancing its operational strength and advancing treatments for patients.

Biohaven Ltd. (NYSE: BHVN) has made significant strides in its clinical development, launching a pivotal Phase 3 study for its myostatin-targeting agent for spinal muscular atrophy. The company initiated a Phase 1 clinical trial for a new TYK2/JAK1 inhibitor, BHV-8000, and reported promising Phase 1 safety data for BHV-7000, which targets epilepsy and mood disorders. The 2022 financial results showed a net loss of $570.3 million, driven by increased R&D expenses. With $465 million in cash, Biohaven is well-positioned for future growth, anticipating major milestones in 2023, including multiple IND submissions and further advancements in their extensive neuroscience pipeline.

Biohaven (NYSE: BHVN) announced the acquisition of global rights, excluding China, for BHV-8000, a novel dual inhibitor targeting TYK2 and JAK1 to treat brain disorders. This first-in-class agent is expected to advance into Phase 1 clinical development in 2023. The agreement with Hangzhou Highlightll Pharmaceutical includes an upfront payment of $10 million in cash and $10 million in Biohaven equity, plus potential milestone payments amounting to up to $950 million. The unique mechanism of BHV-8000 aims to modulate neuroinflammation linked to neurodegenerative disorders, positioning Biohaven for significant advancements in the neurology market.

Biohaven Ltd. (NYSE: BHVN) presented data on its novel compound BHV-7000 at the ASENT 2023 Annual Meeting, focusing on its efficacy and safety in treating epilepsy. BHV-7000, a Kv7.2/7.3 potassium channel activator, shows potent anti-seizure capabilities without negatively impacting neurobehavior. The Phase 1 trial indicated good tolerability at doses up to 100 mg, with no severe adverse events observed. Leading researchers emphasized the potential for BHV-7000 to deliver efficacy without common CNS-related side effects seen in existing anti-seizure medications, marking a significant advancement in epilepsy treatment.

Biohaven has announced that its investigational drug, taldefgrobep alfa, for treating Spinal Muscular Atrophy (SMA), has received Fast Track designation from the U.S. FDA, enhancing its potential for expedited review and approval. This follows the drug's previous acquisition of Orphan Drug Designation. Taldefgrobep aims to increase muscle mass by inhibiting the activity of myostatin, a protein that limits muscle growth. A Phase 3 clinical trial, named RESILIENT, is currently underway. SMA is a rare and progressive neurodegenerative disease affecting approximately 1 in 11,000 newborns in the U.S., highlighting an urgent need for effective treatments.

Pfizer reported record revenues of $100.3 billion for full-year 2022, up 23% year-over-year, driven by operational growth of 30%. Fourth-quarter revenues reached $24.3 billion, marking 2% growth. Reported diluted EPS for 2022 was $5.47, up 42%, while adjusted diluted EPS rose 62% to $6.58. For 2023, Pfizer anticipates revenues of $67.0 to $71.0 billion, primarily due to a decline in COVID-19 product sales. However, excluding these products, operational growth of 7% to 9% is expected. The company aims to invest significantly in launches and R&D to drive long-term growth, including anticipated launches of new products.

Biohaven Ltd. (NYSE: BHVN) announced that CEO Vlad Coric will present at the 41^st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 7:30 am PT in San Francisco. A slide deck of the presentation will be available on Biohaven's website. The company focuses on developing therapies for neurological and neuropsychiatric diseases, leveraging advanced drug development capabilities. Biohaven's pipeline includes candidates for conditions with limited treatment options.

Wilson Sonsini Goodrich & Rosati announces Jon Soderstrom as the new Chief Licensing Advisor (East) in its New York office. Previously managing director at Yale University's Office of Cooperative Research, Soderstrom played a significant role in developing technology transfer initiatives and raising over $1 billion for more than 45 new ventures. His expertise in technology and pharmaceuticals is expected to enhance the firm's client relationships and contributions to the entrepreneurial community on the East Coast.