BHV-8000 is a first-in-clinic, brain-penetrant, and selective inhibitor of TYK2 and JAK1 kinases — a novel investigational therapy with the potential to treat the neuroinflammation and immune dysregulation that drives disease progression in Parkinson's disease (PD) Currently, there are no approved disease-modifying therapies for the more than 10 million people living with PD NEW HAVEN, Conn., May 29, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical com ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Biohaven Ltd. and its officers or directors [1] Group 1: Company Developments - On May 14, 2025, Biohaven announced that the FDA extended the PDUFA date for its new drug application for the treatment of spinocerebellar ataxia by three months to allow for a full review of recent submissions [3] - Following the FDA announcement, Biohaven's stock price dropped by $3.84 per share, or 19.53%, closing at $15.82 per share on May 15, 2025 [3] Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of Biohaven to investigate claims related to potential securities fraud [1] - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a history of recovering multimillion-dollar damages for victims of securities fraud [4]

Core Viewpoint - Biohaven's stock experienced significant volatility, dropping nearly 20% due to a regulatory delay regarding its promising drug, trotziluzole, despite a generally positive market day for other stocks [1][2]. Regulatory Update - The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for Biohaven's drug, troriluzole, by three months, with a new decision expected in the fourth quarter of this year [4]. - The extension is due to the FDA's need for additional time to review recent submissions from Biohaven [5]. Drug Potential - Troriluzole targets spinocerebellar ataxia (SCA), a rare brain disorder with no current treatment options, and has received fast-track, priority review, and orphan drug designation from the FDA [6]. - Investor sentiment remains optimistic about the drug's potential, although the delay has raised concerns about the future approval process [7].

Core Viewpoint - Biohaven Ltd. experienced a significant decline in share price following the FDA's unexpected three-month delay in the review of its rare-disease drug, troriluzole, for spinocerebellar ataxia (SCA) [1][6]. Group 1: Drug Information - Troriluzole, if approved, would be the first FDA-approved treatment for SCA, a neurodegenerative disorder affecting approximately 15,000 people in the U.S. and 24,000 in Europe and the UK [2]. - The drug has shown a favorable benefit-risk profile, with clinical data indicating it can slow disease progression by 50-70% and reduce the risk of falls [4]. Group 2: FDA Review Process - The FDA extended the PDUFA date for the new drug application (NDA) to the fourth quarter of 2025, up from the previously expected third quarter of 2025, to allow for a full review of recent submissions [1][4]. - The FDA did not raise any new concerns during the review process, and an advisory committee meeting is planned, although no date has been set [3][4]. Group 3: Financial and Market Impact - Biohaven has a non-dilutive capital agreement with Oberland Capital Management worth up to $600 million, with $250 million received to support SCA launch planning and ongoing operations [5]. - Following the news of the delay, Biohaven's shares fell by 14.3%, trading at $16.85 [8]. Group 4: Analyst Perspectives - Analysts at William Blair expressed surprise at the delay, noting the increased regulatory uncertainty but maintained an Outperform rating based on the likelihood of approval [6][7]. - They believe the FDA may exhibit more regulatory flexibility due to the rare-disease nature of SCA and the lack of treatment options [7].

Core Viewpoint - Troriluzole is a potential first and only FDA-approved treatment for Spinocerebellar Ataxia (SCA), a rare and life-threatening neurodegenerative disease, with the FDA extending the review period for its new drug application [2][3]. Group 1: Troriluzole and FDA Review - The FDA has extended the PDUFA date for the new drug application of Troriluzole by three months to allow for a full review of recent submissions [2]. - The FDA has not raised any new concerns regarding the application, and a meeting with an advisory committee is planned [2][4]. - Troriluzole has received Fast-Track, Orphan Drug Designation, and Priority Review from the FDA, indicating its potential to significantly improve treatment options for SCA [3][4]. Group 2: Impact of Troriluzole - Clinical data suggests that Troriluzole can slow disease progression by 50-70% as measured by the f-SARA scale and reduce the risk of falls [4]. - SCA affects approximately 15,000 people in the United States and 24,000 in Europe and the UK, leading to significant morbidity and no current approved therapies [5]. Group 3: Mechanism of Action - Troriluzole is a third-generation novel prodrug that modulates glutamate levels, addressing glutamate deregulation associated with neurodegeneration in SCA patients [6]. - The drug increases glutamate uptake from the synapse, enhancing the function of excitatory amino acid transporters on glial cells [6]. Group 4: Company Overview - Biohaven is focused on developing life-changing treatments in key therapeutic areas, including neuroscience, and has a diverse portfolio of drug candidates [7].

UNITED STATES OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-41477 Biohaven Ltd. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 (Exact name of registrant as specified in its charter) British Virgin Islands Not applicable (State or other jurisdiction of incorporation or o ...

Biohaven Reports First Quarter 2025 Financial Results and Recent Business Developments NEW HAVEN, Conn., May 12, 2025 /PRNewswire/ – Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life- changing therapies to treat a broad range of rare and common diseases, today reported financial results for the first quarter ended March 31, 2025, and provided a review of recent accomplishments and antici ...

Group 1 - Biohaven Ltd. (NYSE: BHVN) is a clinical-stage biopharmaceutical company focused on developing treatments for neurological, immunological, oncological, and metabolic conditions [1] - The company's lead asset, Troriluzole, is currently facing regulatory uncertainty in Europe and is awaiting a significant FDA decision in the US [1] - Recently, Biohaven raised $600 million, indicating a strong financial position to support its ongoing development efforts [1]

Core Insights - Biohaven's shares surged approximately 8% following the announcement of a $600 million non-dilutive financing deal with Oberland Capital [1][2] - The financing includes an immediate $250 million, with the remainder contingent on regulatory milestones and strategic acquisitions [2] - The funding aims to support clinical trials and prepare for potential FDA approval of Biohaven's lead candidate, troriluzole, for spinocerebellar ataxia (SCA) [2][3] Financial Details - The total financing deal is valued at up to $600 million, with $250 million available immediately [2] - Biohaven's market capitalization was around $3 billion prior to the financing announcement [4] - The non-dilutive nature of the deal means existing shareholders will not see their ownership percentage decrease [2][4] Product Development - Troriluzole is Biohaven's primary candidate targeting SCA, a rare neurological condition with no current approved therapies [3] - The funding provides Biohaven with significant resources to advance late-stage development of its drug pipeline, which also includes oncology and immunology treatments [3] - The potential FDA approval of troriluzole could significantly enhance Biohaven's valuation [4]

Core Viewpoint - Biohaven Ltd. has entered into a significant investment agreement with Oberland Capital Management for up to $600 million, aimed at supporting ongoing clinical trials and commercialization efforts for its product, troriluzole, targeting spinocerebellar ataxia (SCA) [1][2][3] Group 1: Investment Details - The agreement includes an initial funding of $250 million to be provided at closing on or before April 30, 2025 [1][6] - An additional $150 million is contingent upon FDA approval of troriluzole, with further funding of up to $200 million available for strategic acquisitions and related expenses [3][6] - The investment is structured as a Note Purchase Agreement (NPA) that is non-dilutive to existing shareholders [3][6] Group 2: Product and Market Potential - Troriluzole is a novel prodrug designed to modulate glutamate levels, which has potential applications in various diseases beyond SCA [5][8] - The investment will facilitate the advancement of Biohaven's pipeline, which includes five innovative platforms across immunology, neuroscience, and oncology [3][8] Group 3: Strategic Partnership - Oberland Capital expresses confidence in Biohaven's ability to address unmet needs in rare diseases and is committed to supporting the launch of troriluzole [3][9] - The partnership is expected to leverage Oberland's expertise in funding rare disease product launches, enhancing Biohaven's operational capabilities [3][9]