Biohaven Ltd. - BHVN STOCK NEWS

Biohaven Ltd. announces multiple updates on key programs, including positive preliminary EEG data for BHV-7000, Phase 1 update on BHV-8000, development update on BHV-1300, and regulatory update on troriluzole. BHV-7000 shows promising results in treating epilepsy and bipolar disorder. BHV-8000 achieves projected therapeutic concentrations and is well tolerated. BHV-1300 demonstrates a competitive profile. Troriluzole Phase 3 study enrollment to be completed soon. FDA refuses to review NDA for troriluzole in SCA3, Biohaven requests Type A meeting.

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.