Core Points - A shareholder class action lawsuit has been filed against Biohaven Ltd. alleging materially false and misleading statements regarding the company's business and operations [1] - The lawsuit specifically claims that the regulatory prospects of troriluzole for treating spinocerebellar ataxia and the efficacy of BHV-7000 for bipolar disorder were overstated [1] - The lawsuit suggests that the revelation of these issues could significantly negatively impact Biohaven's business and financial condition [1] Legal Context - Shareholders who purchased Biohaven shares between March 24, 2023, and May 14, 2025, and experienced significant losses are encouraged to discuss their legal rights [2] - The deadline for shareholders to request to be appointed as lead plaintiff in the case is September 12, 2025 [3] - Holzer & Holzer, LLC is representing shareholders and has a history of recovering significant amounts for investors affected by corporate misconduct [3]

Core Viewpoint - A securities class action lawsuit has been filed against Biohaven Ltd. for allegedly making false and misleading statements regarding its drug candidates, which has negatively impacted its stock price and financial condition [1][2]. Group 1: Legal Action - A class action lawsuit has been initiated in the U.S. District Court for the District of Connecticut on behalf of individuals or entities that acquired Biohaven securities between March 24, 2023, and May 14, 2025 [1]. - The lawsuit claims that Biohaven overstated the regulatory prospects of its drug troriluzole and the efficacy of BHV-7000 for bipolar disorder, which were not disclosed accurately [2]. Group 2: Stock Price Impact - Following the FDA's rejection of the troriluzole NDA on July 27, 2023, Biohaven's stock price dropped by $5.38, or 22.61%, closing at $18.42 per share [3]. - On March 3, 2025, after disclosing disappointing results for BHV-7000, Biohaven's stock fell by $5.12, or 13.77%, closing at $32.06 per share [5]. Group 3: Company Developments - Biohaven resubmitted the troriluzole NDA to the FDA on December 16, 2024, citing additional positive efficacy data [4]. - The company reported that a late-stage study of BHV-7000 did not meet its primary outcome measure, raising concerns about its clinical prospects [5].

Pipeline Highlights - Troriluzole's NDA is under priority review for Spinocerebellar Ataxia (SCA), with a PDUFA date in 2H 2025[14, 118, 434], and if approved, commercial launch is expected in 2H 2025[434] The company estimates there are approximately 15,000 SCA patients in the US[441, 502] and troriluzole reduced SCA disease progression by 50% to 70% in RWE study[463, 468, 473, 501] - Kv7 activator BHV-7000 expects topline results for Major Depressive Disorder (MDD) in 2H 2025[14, 158, 161, 216] and Phase 3 focal epilepsy study topline results in 1H 2026[14, 158, 163] - Taldefgrobep Alfa has a planned FDA interaction in 1H 2025 regarding the Spinal Muscular Atrophy (SMA) registrational path[12, 396] and a Phase 2 obesity study is planned for 2H 2025[12, 342] - IgG Degrader BHV-1300 is expected to initiate a pivotal Graves' disease study in 2H 2025[10, 85, 90, 91, 40, 42] and Myasthenia Gravis study in 2026[10, 42, 93, 94] - Gd-IgA1 Degrader BHV-1400 completed Phase 1 and is expected to initiate a pivotal IgA Nephropathy (IgAN) study in 2026[10, 42, 47, 64] - β1AR AAb Degrader BHV-1600 expects to complete Phase 1 in 2H 2025 and initiate a pivotal Peripartum Cardiomyopathy (PPCM) study in 2026[10, 42, 114, 119] Immunology & Inflammation Platform - The company's MoDE and TRAP degraders have been dosed in 166 individuals[35] - BHV-1300 achieved median maximal reductions in total IgG of 83% by day 18[70, 73] - A single subcutaneous dose of BHV-1400 delivered rapid, selective, deep, and sustained reductions in Gd-IgA1 of up to 81% without suppression of healthy immunoglobulins[55] Oncology Platform - Trop2 ADC BHV-1510 is in Phase 1, with interim data expected in 2H 2025[12, 524, 581] Preliminary data shows tumor reduction in first 6 patients treated with BHV-1510 + cemiplimab combination[543, 546] - FGFR3 ADC BHV-1530 initiated Phase 1 in April 2025[12, 524, 576, 581] Financial Update - The company has approximately $518 million in cash[578, 579] - Potential royalties from Pfizer could reach up to $400 million per year, based on low- to mid-teens % of annual US net sales of rimegepant and zavegepant exceeding $525 billion[577, 578]

Core Insights - Bexorg, Inc. has announced a multi-program research collaboration with Biohaven Ltd. to advance next-generation therapies for central nervous system (CNS) disorders [1] - Bexorg's whole-brain discovery platform is unique in its ability to restore metabolic and molecular activity in isolated human and pig brains, enabling high-resolution insights into neurodegeneration [2][5] - The collaboration aims to provide insights into pharmacokinetics, pharmacodynamics, and mechanisms of action for Biohaven's therapeutics, potentially identifying novel biomarkers for clinical trials [3] Company Overview - Bexorg is a techbio company focused on CNS drug discovery, utilizing a proprietary platform called BrainEx to generate clinically predictive data from postmortem human brains [5][6] - Biohaven is a biopharmaceutical company developing treatments in areas such as immunology, neuroscience, and oncology, with a diverse portfolio including therapies for epilepsy, mood disorders, and cancer [4] Technological Advancements - Bexorg's whole-brain perfusion technology allows for the extraction of detailed transcriptomic, proteomic, and metabolic data, which is essential for machine learning and AI-driven drug discovery [2][6] - The platform addresses the limitations of traditional preclinical models by providing a more accurate representation of human brain structure and function, thus enhancing CNS drug development [3]

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 ...