Biohaven Pharmaceutical Hld

Biohaven Ltd. operates as a biopharmaceutical company that focuses on neurological and neuropsychiatric diseases. Its portfolio includes treatments for medical needs including focal epilepsy, obsessive compulsive disorder, spinocerebellar ataxia and spinal muscular atrophy. The company was founded on May 2, 2022 and is headquartered in New Haven, CT.

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Biohaven Ltd. is a global clinical stage biopharmaceutical company, which engages in the discovery, development, and commercialization of therapies for people with neurological and neuropsychiatric diseases. The company was founded on May 2, 2022 and is headquartered in New Haven, CT.

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NEW HAVEN, Conn. , April 18, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Announces Pricing of $230 Million Public Offering of Common Shares

Biohaven's first-in-class Molecular Degrader of Extracellular Proteins (MoDE™) technology targeting IgG removal, BHV-1300, was selected for an oral presentation at AAN highlighting its novel mechanism of action and the latest preclinical data demonstrating rapid, robust, and selective target removal Biohaven announces it will present safety and IgG lowering data from its ongoing single ascending dose (SAD) study of BHV-1300 at the company's annual R&D day at the Yale Innovation Summit in New Haven, Connecticut on May 29, 2024 Safety, tolerability, and target engagement data showing the differentiated profile of BHV-7000 as a potential best-in-class Kv7 activator will be presented as both oral and poster presentations; the Phase 2/3 focal epilepsy program is now enrolling patients AAN Abstract of Distinction awarded to BHV-2100, which demonstrated potent reversal of pain in preclinical models and favorable initial safety and pharmacokinetic data in Phase 1 studies, highlighting the potential for TRPM3 antagonism as a novel nonopioid target to treat pain and migraine Oral and poster presentations of troriluzole as a novel glutamate modulating agent with favorable pharmacokinetics, safety, and outcomes data in the potential treatment of neurologic and neuropsychiatric disorders Biohaven announces the Data Monitoring Committee for its Phase 3 trial in obsessive-compulsive disorder convened in the second quarter to review the interim analysis and informed the Company that the study may continue Additional efficacy and safety data regarding troriluzole in spinocerebellar ataxia will also be presented in both oral and poster format Poster presentation of RESILIENT Phase 3 study design with taldefgrobep alfa in spinal muscular atrophy; study completed enrollment and topline results anticipated in the second half of 2024 Biohaven announces the FDA granted "rare pediatric disease" designation for taldefgrobep alfa thereby providing the potential to receive a priority review voucher (PRV) if ultimately approved for the indication of spinal muscular atrophy Other presentations and posters include development of the PARCOMS, a new outcome measure for Parkinson's disease clinical trials, application of machine learning in video assessment of gait, and data demonstrating a reduced risk for Parkinson's disease in patients taking anti-inflammatory agents Three oral presentations and 6 poster presentations from the Biohaven Clinical and Health Outcomes group describe the development and validation of novel scales and natural history studies in support of troriluzole and BHV-8000 development programs, the impact of immune-modulating therapy in Parkinson's disease, the burden of illness in focal epilepsy and KCNQ2-DEE (BHV-7000), and the application of AI machine learning technology to quantify patient mobility with troriluzole in spinocerebellar ataxia DENVER, CO and NEW HAVEN, Conn. , April 13, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Showcases Innovative Neuroscience Portfolio with 20 Presentations at the 2024 American Academy of Neurology (AAN) Annual Meeting and Provides Other Business Updates

Driving clinical, regulatory, and operational excellence across five innovative platforms focused on immunology, neuroscience, and oncology: Portfolio targeting large indications including obesity, epilepsy, bipolar disorder, depression, obsessive-compulsive disorder (OCD), migraine, pain, Alzheimer's disease, Parkinson's disease, multiple sclerosis, rheumatoid arthritis, and cancer. Also advancing potential novel treatments for rare autoimmune and inflammatory diseases, including myasthenia gravis, cardiomyopathy, spinal muscular atrophy (SMA) and IgA nephropathy.

Biohaven Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Developments

Biohaven's stock rose 130% post "Sell" recommendation; overlooked assets like BHV-7000 suggest early growth stages remain. The company's pipeline, particularly their Kv7 activators and IgG degrader, show promise and have blockbuster potential in treating epilepsy and immune-mediated diseases. Financially, with a cash runway extended to 20.7 months post-offering, Biohaven shows robust short-term health.

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Five proprietary platforms fueling multiple clinical programs Targeting large indications including epilepsy, bipolar disorder, depression, obsessive-compulsive disorder, migraine, pain, obesity, Alzheimer's disease, Parkinson's disease, multiple sclerosis, rheumatoid arthritis, and cancer. Plus, rare autoimmune and inflammatory diseases, including myasthenia gravis, cardiomyopathy, spinal muscular atrophy and IgA nephropathy NEW HAVEN, Conn.

Biohaven Highlights Progress Across Innovative Portfolio and Outlines 2024 Anticipated Milestones at the 42nd Annual J.P. Morgan Healthcare Conference; Established Extensive Portfolio Across 20 Therapeutic Indications in Neuroscience, Immunology and Oncol

NEW HAVEN, Conn. , Jan. 2, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven to Present at the 42nd Annual J.P. Morgan Healthcare Conference

Biohaven reported full results from the BHV-7000 Phase 1 study examining doses up to 120 mg daily, demonstrating BHV-7000 was well-tolerated at all doses studied without the typical central nervous system (CNS) adverse effects associated with other anti-seizure medications (ASMs), such as somnolence and cognitive/mood disturbances. In a Phase 1 electroencephalogram (EEG) biomarker study, BHV-7000 demonstrated dose-dependent target engagement in the brain as measured by changes in EEG spectral power across all brain regions.

Biohaven Presents Expanded EEG and Safety Data for BHV-7000 at the American Epilepsy Society Annual Meeting

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Cash, cash equivalents, marketable securities and restricted cash totaled approximately $495 million on October 5, 2023, which included net proceeds of $242 million from completed public offering on October 5, 2023 Completed public offering of 11,761,363 Biohaven Ltd. common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of $22.00 per share Announced important updates on the Company's immunology and extracellular protein degradation platform: Immunoglobulin G (IgG) degrader BHV-1300 demonstrated IgG reductions of greater than 90% from baseline with repeat dosing in non-human primates BHV-1300 offers a mechanism of action that is differentiated from neonatal Fc receptor (FcRn) targeting agents with the potential for a faster onset of action, deeper reductions in IgG, no mechanistic effects on albumin or cholesterol, self-administered subcutaneous dosing, and ability to dose in conjunction with Fc-containing biologic therapeutic agents Data support Biohaven's strategy of advancing BHV-1300 in combination with standard-of-care treatments for rheumatoid arthritis Investigational New Drug (IND) submission for BHV-1300 remains on track for 2023 with Phase 1 initiation anticipated shortly thereafter BHV-1300 provides roadmap for accelerated development of future assets from Biohaven's targeted extracellular protein degradation platform; several targets using second and third generation technologies expected to yield sustainable pipeline with potential to add significant value across rare and common diseases IND submission for IgA degrader BHV-1400 for IgA nephropathy and a third undisclosed extracellular protein degrader target IND submission expected in 2024 Announced positive data from electroencephalogram (EEG) biomarker study of BHV-7000 confirming central nervous system (CNS) activity, and other important updates including: Dose-dependent and time-dependent effects on EEG across all brain regions and spectral frequencies Successfully completed development of extended-release (ER) formulation of BHV-7000 to enable once-daily dosing in clinical trials; established relative bioavailability of the ER to standard release formulation Differentiated safety profile from Phase 1 SAD/MAD study showing favorable CNS adverse event profile compared to other ASMs Phase 3 study in focal epilepsy on track to commence in 2023 and mood disorder study to begin shortly thereafter Announced continued progress with taldefgrobep alfa, the Company's anti-myostatin adnectin program Presented preclinical data demonstrating taldefgrobep alfa reduces fat and improves lean mass at ObesityWeek® Completed enrollment in pivotal Phase 3 study of taldefgrobep alfa for the treatment of spinal muscular atrophy (SMA) Taldefgrobep granted orphan drug designation (ODD) for SMA by the European Commission; taldefgrobep previously received FDA Fast-Track and ODD Announced successful completion of the SAD portion of the Phase 1 trial for BHV-8000, a brain penetrant TYK2/JAK1 inhibitor, and initiation of the MAD cohort to enable a Phase 2/3 clinical trial in 2024 European Medicines Agency (EMA) informed the Company that its Marketing Authorization Application (MAA) for troriluzole (Dazluma) in the treatment of spinocerebellar ataxia has been validated and is now under review by EMA's Committee for Medicinal Products for Human Use (CHMP) NEW HAVEN, Conn.

Biohaven Reports Third Quarter 2023 Financial Results and Recent Business Developments

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- Taldefgrobep is a novel myostatin inhibitor with the potential to be an important therapy for neuromuscular disorders and metabolic diseases including obesity. - Taldefgrobep monotherapy significantly reduced fat and increased lean muscle mass in an obese mouse model; potential body composition changes relevant to individuals living with overweight and obesity.

Biohaven Presents Preclinical Data Demonstrating Taldefgrobep alfa Reduces Fat and Improves Lean Mass at The Obesity Society's Annual Meeting, ObesityWeek®

NEW HAVEN, Conn. , Oct. 2, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Announces Pricing of $225 Million Public Offering of Common Shares

NEW HAVEN, Conn. , Oct. 2, 2023 /PRNewswire/ -- Biohaven Ltd.

BIOHAVEN ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON SHARES

Biohaven (BHVN) gains on preliminary data from a pre-clinical study on its pipeline candidate BHV-1300 targeting various autoimmune diseases.

Biohaven (BHVN) Up on Positive Data from Autoimmune Disease Drug

Biohaven could rival Argenx and Immunovant after unveiling results Wednesday for an autoimmune diseases drug. BHVN stock rocketed.

Biohaven, Yet Another Argenx Rival In Autoimmune Drugs, Just Rocketed 29%

Biohaven released a new investor presentation that featured encouraging information about drug candidate BHV-1300. The experimental drug showed promise in treating autoimmune diseases.

Why Biohaven Stock Is Skyrocketing Today

- Taldefgrobep alfa is the only myostatin inhibitor in clinical development that targets both myostatin and activin A signaling, two key regulators of muscle mass and adipose tissue - RESILIENT, the pivotal clinical trial in spinal muscular atrophy, was designed to test the efficacy and safety of taldefgrobep alfa as adjunctive therapy to increase muscle in SMA patients treated with standard of care nusinersen, risdiplam or onasemnogene abeparvovec-xioi NEW HAVEN, Conn. , Sept. 14, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Completes Enrollment in Pivotal Phase 3 Study of Taldefgrobep Alfa in Spinal Muscular Atrophy

Examination of EEG in healthy subjects administered single doses of BHV-7000 confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications. EEG results demonstrated dose-dependent and time-dependent effects of BHV-7000 on CNS target engagement in study subjects: At the lowest dose studied of 10 mg, subjects with targeted drug concentrations ≥ EC50 showed a mean increase in EEG spectral power in beta and gamma bands while there were no meaningful changes in spectral power in subjects with drug concentrations

Biohaven Announces Positive Data from its Exploratory Electroencephalogram (EEG) Biomarker Study of BHV-7000, Completion of Once-Daily Formulation Development, and Plan to Initiate Phase 3 Pivotal Studies

NEW YORK , Aug. 18, 2023 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Biohaven Ltd. ("Biohaven" or the "Company") (NYSE: BHVN).

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