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Biohaven (BHVN) Earnings Call Presentation
2025-07-04 11:59
Corporate Presentation June 2025 JENNIFER Living with SCA3 JENNIFER Living with SCA3 Participant in the Troriluzole Clinical Study © 2025 Biohaven, Ltd. All rights reserved. Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Biohaven Ltd. (the "Company") and our planned and ongoing trials for our troriluzole, taldefgrobep alfa, BHV-7000, BHV-2100, BHV-8000, BHV-1300, BHV-1400, ...
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].
Why Is Biohaven Stock Falling On Thursday?
Benzinga· 2025-05-15 17:22
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].
FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia
Prnewswire· 2025-05-14 22:43
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].
Biohaven .(BHVN) - 2025 Q1 - Quarterly Report
2025-05-12 20:17
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 .(BHVN) - 2025 Q1 - Quarterly Results
2025-05-12 20:08
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 ...
Why BioHaven Stock Is Soaring Today
The Motley Fool· 2025-04-28 17:16
Shares of Biohaven (BHVN 5.04%) are surging on Monday. The company's stock was up about 8% as of midday trading and had climbed as much as 10% earlier in the day. The move comes as the S&P 500 traded mixed and the Nasdaq Composite drifted slightly higher.Shares of the clinical-stage biopharmaceutical company were rising after Biohaven announced a $600 million non-dilutive financing deal with Oberland Capital.A big cash infusionBiohaven revealed it has secured up to $600 million from the investment firm Ober ...