Workflow
Biohaven .(BHVN)
icon
Search documents
BHVN Investors Have Opportunity to Lead Biohaven Ltd. Securities Fraud Lawsuit with the Schall Law Firm
Prnewswire· 2025-07-16 09:10
Core Viewpoint - A class action lawsuit has been filed against Biohaven Ltd. for alleged violations of securities laws, specifically related to misleading statements about its drug candidates [1][4]. Group 1: Lawsuit Details - The lawsuit is based on allegations that Biohaven made false and misleading statements regarding the regulatory prospects of its drug candidate, troriluzole, and the efficacy of BHV-7000 for bipolar disorder [4]. - The class period for the lawsuit is defined as March 24, 2023, to May 14, 2025, during which investors are encouraged to participate if they suffered losses [2]. Group 2: Investor Information - Investors who purchased Biohaven's securities during the class period are urged to contact the Schall Law Firm before September 12, 2025, to discuss their rights [2][3]. - The class has not yet been certified, meaning that until certification occurs, affected investors are not represented by an attorney [3].
Shareholder Alert: Robbins LLP Informs Investors of the Biohaven Ltd. Corporation Class Action
Prnewswire· 2025-07-16 04:56
Core Viewpoint - A class action lawsuit has been filed against Biohaven Ltd. for allegedly misleading investors regarding the viability of its drug candidates, particularly troriluzole and BHV-7000 [1][2]. Group 1: Company Overview - Biohaven Ltd. is a biopharmaceutical company focused on developing therapies in immunology, neuroscience, and oncology [1]. - The company is working on several product candidates, including troriluzole for spinocerebellar ataxia (SCA) and BHV-7000 for bipolar disorder [1]. Group 2: Allegations - The lawsuit claims that Biohaven overstated the regulatory prospects and data sufficiency for troriluzole as a treatment for SCA [2]. - It is also alleged that the efficacy and clinical prospects of BHV-7000 for bipolar disorder were similarly overstated [2]. - The revelations from the lawsuit are expected to have a significant negative impact on Biohaven's business and financial condition [2]. Group 3: Legal Proceedings - Shareholders interested in serving as lead plaintiffs must file their papers by September 12, 2025 [3]. - Participation in the case is not required to be eligible for recovery, allowing shareholders to remain absent class members if they choose [3].
BHVN INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Biohaven Ltd. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
GlobeNewswire News Room· 2025-07-15 20:00
Core Viewpoint - A class action lawsuit has been filed against Biohaven Ltd. for alleged violations of federal securities laws, claiming that the company made materially false and misleading statements regarding its business and operations [1][2]. Class Definition - The lawsuit seeks to recover damages for all individuals and entities that purchased Biohaven securities between March 24, 2023, and May 14, 2025, inclusive [2]. Case Details - The Complaint alleges that Defendants overstated the regulatory prospects of troriluzole as a treatment for SCA and the efficacy of BHV-7000 for bipolar disorder, which could significantly negatively impact Biohaven's business and financial condition [3]. Next Steps - Investors who suffered losses in Biohaven have until September 12, 2025, to request to be appointed as lead plaintiff in the case [4]. Cost Structure - The law firm represents investors on a contingency fee basis, meaning they will only seek reimbursement for expenses and fees if successful [5]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that has recovered hundreds of millions of dollars for investors in securities fraud class actions [6].
INVESTOR ALERT: Class Action Lawsuit Filed on Behalf of Biohaven Ltd. (BHVN) Investors – Holzer & Holzer, LLC Encourages Investors With Significant Losses to Contact the Firm
GlobeNewswire News Room· 2025-07-15 16:18
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]
Gainey McKenna & Egleston Announces a Class Action Lawsuit Has Been Filed Against Biohaven Ltd. (BHVN)
GlobeNewswire News Room· 2025-07-15 14:46
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].
Biohaven (BHVN) Earnings Call Presentation
2025-07-04 11:59
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]
Bexorg Announces Research Collaboration with Biohaven Leveraging Its Novel AI-Driven Whole-Brain Discovery Platform to Enhance CNS Drug Development
GlobeNewswire News Room· 2025-06-10 18:00
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]
Biohaven Enrolls First Patient into Phase 2/3 Trial in Early Parkinson's Disease, Targeting Neuroinflammation with Novel Brain-Penetrant TYK2/JAK1 Inhibitor
Prnewswire· 2025-05-29 11:01
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 ...
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biohaven Ltd. - BHVN
GlobeNewswire News Room· 2025-05-22 13:00
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]
Why Biohaven Stock Dove by Nearly 20% on Thursday
The Motley Fool· 2025-05-15 22:03
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].