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.

Taldefgrobep alfa, in Phase 3 global clinical development for Spinal Muscular Atrophy, granted EU Orphan Drug Designation in addition to previously receiving Fast Track and Orphan Drug Designation in the US NEW HAVEN, Conn. , July 31, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven's Taldefgrobep Alfa Receives EU Orphan Drug Designation for Spinal Muscular Atrophy

Cash, cash equivalents, and marketable securities totaled $349.0 million as of June 30, 2023 Announced positive interim data from BHV-7000 EEG biomarker study demonstrating evidence of central nervous system (CNS) target engagement, confirming previously reported preclinical and clinical data, and highlighting the paradigm-changing potential of BHV-7000 in the treatment of epilepsy and mood disorders Brain penetrant TYK2/JAK1 inhibitor, BHV-8000, advanced into Phase 1 with projected therapeutic concentrations achieved and well-tolerated profile observed to date Biohaven anticipates initiating a Phase 2 clinical trial in Parkinson's disease and potentially other neuroinflammatory diseases in 2024 Advanced targeted extracellular protein degradation platform with potential to support numerous clinical candidates across a broad range of high unmet need indications Investigational New Drug (IND) submission for pan-IgG degrader, BHV-1300, on track for the second half of 2023 with potential to treat multiple immune-mediated diseases IND submission with IgA degrader for IgA nephropathy expected in the first half of 2024 Orphan drug designation (ODD) granted by the European Commission for taldefgrobep alfa a novel anti-myostatin adnectin, for the treatment of spinal muscular atrophy (SMA) taldefgrobep previously received Fast-Track and ODD from the FDA taldefgrobep Phase 3 SMA trial expected to complete enrollment in the second half of 2023 Type A meeting planned with FDA regarding troriluzole program in Spinocerebellar Ataxia Type 3 (SCA3) and enrollment in Phase 3 obsessive compulsive disorder (OCD) trial expected to complete at end of 2023 NEW HAVEN, Conn. , July 31, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Reports Second Quarter 2023 Financial Results and Recent Business Developments

The FDA refused to review Biohaven's filing for approval of troriluzole in treating an ultrarare disease. Biohaven still hopes to convince the agency of the merits of its data on the experimental drug.

Why Biohaven Stock Is Crashing Today

NEW HAVEN, Conn. , July 27, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Provides Preliminary EEG Data Update for Kv7 Platform, Regulatory Update on Troriluzole and Other Corporate Updates

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BridgeBio stock collapsed when acoramidis failed a pivotal trial, but follow-up data on the way could allow the program, and the stock, to redeem itself. Biohaven shares could shoot higher if the U.S. Food and Drug Administration accepts the company's latest new drug application.

2 Growth Stocks With Major Incoming Catalysts

Biohaven offers a diverse portfolio of innovative drug development assets targeting various therapeutic areas, with a focus on neurodegenerative and neuroinflammatory conditions. The company's robust financials, diverse revenue streams, and recent performance results indicate a bright future and strong investment potential. Biohaven's innovative approaches and unique mechanisms of action set it apart from competitors, positioning the company as a compelling investment opportunity in the biopharmaceutical industry.

Biohaven: A Promising Investment In Innovative Neurological Therapies

Wednesday, Biohaven held a research and development day presentation for investors. With the company making progress on several fronts, investors appear to be optimistic about its post-buyout future.

Why Biohaven Stock Caught Fire This Week

At its R&D Day, Biohaven (BHVN) provides updates on its pipeline. It also announced submission of a regulatory filing seeking approval for troriluzole in SCA3, an ultra-rare disorder.

Biohaven (BHVN) Stock up 8% on Encouraging Pipeline Updates

Biohaven is coming "out of stealth mode," an analyst said Thursday as BHVN stock climbed for a fourth consecutive day.

How Biohaven Is Coming 'Out Of Stealth Mode' — And Bullishly Extending A 4-Day Run

Submitted a new drug application (NDA) for troriluzole in Spinocerebellar Ataxia Type 3 (SCA3) to U.S. FDA in 2Q2023, marking the team's fourth NDA in approximately 3 years Released additional data from Kv7 platform, including Phase 1 safety data by dose groups for BHV-7000 that further validates differentiated profile Projected Phase 3 Spinal Muscular Atrophy trial to complete enrollment in 2023 Initiated Phase 1 study of brain penetrant TYK2/JAK1 inhibitor, BHV-8000, and anticipate beginning Phase 2 trial in Parkinson's disease next year Highlighted robust pipeline with multiple INDs planned to be filed within the next year, including pan IgG degrader for multiple immune-mediated diseases in 2023 NEW HAVEN, Conn. , May 31, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Provides Overview of Clinical Progress, Regulatory Updates, and Pipeline Developments at R&D Day

NEW HAVEN, Conn. , May 25, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven to Present R&D Day at Yale School of Management

Acquired exclusive license for oral, brain-penetrant, dual TYK2/JAK1 inhibitor for immune-mediated brain disorders in March 2023 covering global rights (excluding China) Appointed Nick Kozauer, M.D. as SVP of Clinical Development and Regulatory Strategy following his tenure as Director of the Division of Neurology 2 in the Office of New Drugs of the U.S. Food and Drug Administration Taldefgrobep alfa granted Fast Track Designation in SMA Driving strong and consistent progress across six robust drug development platforms in 2023: in Kv7 activation, targeting Phase 2/3 study start in focal epilepsy and bipolar disorder in the second half of 2023; Phase 1 study initiation planned with potentially first-in-class TYK2/JAK1 brain-penetrant inhibitor in immune-mediated brain disorders; three Phase 3 studies gaining momentum with regulatory engagement and enrollment completion expected in programs spanning glutamate modulation in SCA and OCD, respectively, and enrollment ongoing in myostatin inhibition program in SMA; three IND submissions anticipated in 2023 spanning Kv7 activation, TRPM3 antagonism, and IgG degradation offer potential to drive long-term value creation beyond 2023 NEW HAVEN, Conn.

Biohaven Reports First Quarter 2023 Financial Results and Reports Recent Business Developments

NEW HAVEN, Conn. , April 17, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Expands Executive Leadership Team with Appointment of Nick Kozauer M.D. as Senior Vice President for Clinical Development and Regulatory Strategy

Here is how Biohaven Ltd. (BHVN) and Hologic (HOLX) have performed compared to their sector so far this year.

Is Biohaven Ltd. (BHVN) Stock Outpacing Its Medical Peers This Year?

Acquired exclusive license for oral, brain-penetrant, dual TYK2/JAK1 inhibitor for immune-mediated brain disorders in March 2023 covering global (ex-China) rights; Phase 1 clinical trial initiation anticipated in 2023 Completed Phase 1 SAD/MAD study with BHV-7000 from our Kv7 ion channel activator platform and reported preliminary safety and tolerability data Commenced enrollment in pivotal Phase 3 study with our myostatin targeting agent, adnectin taldefgrobep alfa, for spinal muscular atrophy Presented preclinical data from our IgG degrader, BHV-1300, showing robust reduction of IgG levels; observed depletion of IgG beginning within hours of dosing and reached 75% depletion of IgG from baseline within three days after a single dose As previously reported, Biohaven Ltd. launched post-closing of the Biohaven Pharmaceutical Holding Company Ltd.

Biohaven Reports Fourth Quarter and Full Year 2022 Financial Results and Reports Recent Business Developments

Biohaven (BHVN) has acquired an exclusive license for dual Inhibitor of TYK2/JAK1 for the pre-clinical study of immune-mediated brain disorders.

Biohaven (BHVN) Acquires Dual Inhibitor for Brain Disorders

Novel first-in-class, brain-penetrant, dual inhibitor of TYK2/JAK1 offers wide therapeutic index with TYK2 inhibition and high selectivity for JAK1 inhibition without the severely limiting adverse class effects of JAK2/JAK3 inhibitors Exclusive license covers global rights excluding China region Biohaven anticipates initiating Phase 1 clinical development in 2023 NEW HAVEN, Conn. , March 22, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders

BHV-7000 differs pharmacologically and structurally from other known Kv7 compounds in development BHV-7000 demonstrates potent anti-seizure activity without effects on neurobehavior in preclinical models BHV-7000 CNS side effect profile in Phase 1 compares favorably to anti-seizure medications currently approved and in clinical development    NEW HAVEN, Conn. , March 14, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven Announces Presentation at the American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting

Biohaven is on the far side of its spin cycle and faces the world as a much diminished company. Biohaven has upcoming catalysts, but they are either early stage or have serious question marks.

Biohaven: Spun And Done - Time To Exit

Biohaven (BHVN) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for Biohaven (BHVN)

-  Taldefgrobep alfa, a myostatin-targeting biologic investigational agent, in Phase 3 development to increase muscle mass for Spinal Muscular Atrophy patients now granted Fast Track in addition to previously receiving Orphan Drug Designation in the US NEW HAVEN, Conn. , Feb. 21, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven's Taldefgrobep Alfa Receives FDA Fast Track Designation for Spinal Muscular Atrophy

Biohaven is taking the same tact that led to a nearly $12 billion Pfizer buyout with the rest of its pipeline — and BHVN stock has soared. The post Here's What's Next For Biohaven After Its $12 Billion Pfizer Buyout, According To CEO Vlad Coric appeared first on Investor's Business Daily.

Here's What's Next For Biohaven After Its $12 Billion Pfizer Buyout, According To CEO Vlad Coric

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NEW HAVEN, Conn. , Jan. 6, 2023 /PRNewswire/ -- Biohaven Ltd.

Biohaven to Present at the 41st Annual J.P. Morgan Healthcare Conference

Biohaven Ltd. (BHVN) is technically in oversold territory now, so the heavy selling pressure might have exhausted.

News for Biohaven Pharmaceutical Hld Stock (BHVN)