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.

Biohaven stock crashed Wednesday after the company's experimental protein-degrading drug lagged investor expectations.

Biohaven Crashes After Protein-Degrading Drug Misses Expectations; Immunovant, Argenx Jump

Reports new positive interim data from the ongoing Phase 1 study of BHV-1300, Biohaven's lead investigational drug from its Molecular Degrader of Extracellular Proteins (MoDE™) platform BHV-1300 demonstrates dose-dependent and rapid IgG reductions within hours of administration No SAEs, no severe AEs,  most AEs were mild, deemed unrelated to study drug and resolved spontaneously No clinically significant changes in LFTs across any dose cohorts to date Highlights advances from novel ion channel program targeting Kv7 activation and TRPM3 antagonism across multiple neurological, pain and neuropsychiatric disease indications Recently initiated a total of 5 pivotal clinical trials with selective Kv7 activator, BHV-7000, targeting focal epilepsy, idiopathic generalized epilepsy, bipolar disorder and major depressive disorder Released positive Phase 1 data with TRPM3 antagonist BHV-2100 showing drug concentrations above EC90 target and well-tolerated profile across all doses in SAD/MAD study; advancing Phase 2 study in migraine Anticipates Myostatin program topline data for Phase 3 Spinal Muscular Atrophy (SMA) study in 2H2024 Reports new preclinical data highlighting potential for taldefgrobep alfa as monotherapy and in combination with GLP-1 agonists for weight loss: Taldefgrobep alfa in combination with GLP-1 in the diet-induced obesity preclinical model showed greater reductions in body weight and fat mass, and a larger increase in lean muscle mass, compared to GLP-1 alone Taldefgrobep alfa demonstrated direct effects on fat reduction as measured by changes in adipocytes independent of increasing muscle mass Releases positive Phase 1 data with BHV-8000, a brain-penetrant TYK2/JAK1 inhibitor, showing preliminary safety and achievement of target concentrations with reductions in inflammatory biomarkers in SAD/MAD study Key updates for BHV-8000 include favorable regulatory feedback enabling initiation of registrational programs for the prevention of ARIA associated with amyloid lowering drugs and Parkinson's disease As announced in an earlier press release today, first patient dosed with Biohaven's novel Trop-2 antibody drug conjugate (ADC), BHV-1510, in Phase 1/2 trial, as monotherapy and initiating combination with Regeneron's anti-PDL1 Libtayo®(cemiplimab-rwlc), in advanced or metastatic epithelial tumors NEW HAVEN, Conn. , May 29, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Showcases Broad Innovative Portfolio and Pipeline Updates Across Multiple Therapeutic Areas including Immunology, Neuroscience, Metabolic Disorders and Oncology at Annual Investor R&D Day

Regeneron Pharmaceuticals

-BHV-1510 is a novel trophoblast cell surface antigen-2 (Trop-2) directed antibody drug conjugate (ADC) that has demonstrated a highly differentiated preclinical monotherapy efficacy profile, the potential for broader therapeutic margin than other Trop-2 ADCs currently in development, and synergistic affects when combined with anti-PD1 therapy -Biohaven also entered into a clinical supply agreement with Regeneron to study the combination of BHV-1510 with Regeneron's anti-PD-1 Libtayo® (cemiplimab-rwlc) in the Phase 1/2 clinical trial -Malignancies of epithelial tissue account for the vast majority of all cancers and the advanced  or metastatic forms of these carcinomas represent an urgent unmet medical need NEW HAVEN, Conn. , May 29, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Doses First Patient with its Novel Trop-2 Directed Antibody Drug Conjugate (ADC) BHV-1510 in Advanced or Metastatic Epithelial Tumors

Biohaven Ltd. is a spinout of Biohaven Pharmaceutical, focusing on developing drugs in the life sciences field. BHVN has three Phase 3 drug candidates: troriluzole for OCD, taldefgrobep alfa for SMA, and BHV-7000 for epilepsy and bipolar disorder. Also, the company has a diverse pipeline of drugs in various stages, including those targeting neurology, immunology, and oncology.

Biohaven: Promising Pipeline With Troriluzole, Taldefgrobep Alfa, And BHV-7000 Leading The Charge

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

Down -24.55% in 4 Weeks, Here's Why Biohaven Ltd. (BHVN) Looks Ripe for a Turnaround

The heavy selling pressure might have exhausted for Biohaven Ltd. (BHVN) as it is technically in oversold territory now.

Down -32.76% in 4 Weeks, Here's Why Biohaven Ltd. (BHVN) Looks Ripe for a Turnaround

Cash, cash equivalents, marketable securities and restricted cash totaled approximately $287.6 million on March 31, 2024, which excludes the net proceeds of approximately $247.8 million from Biohaven's public offering completed on April 22, 2024 Completed public offering of 6,451,220 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 $41.00 per share Reported preliminary summary of data from ongoing single ascending dose (SAD) study with the lead asset from Biohaven's Molecular Degrader of Extracellular Proteins (MoDE™) platform, BHV-1300 FDA granted rare pediatric disease designation for the Company's anti-myostatin, taldefgrobep alfa, providing potential to receive priority review voucher (PRV) if ultimately approved for the indication of spinal muscular atrophy (SMA) Completed a "buy-back" of partial royalty and milestone considerations from Knopp for the BHV-7000 and other Kv7 pipeline programs, replacing up to low teens royalty obligations with a flat mid-single digit royalty along with certain reduced future milestones Phase 2 and 3 programs in epilepsy, major depressive disorder (MDD) and bipolar disorder initiated with selective Kv7 activator, BHV-7000 Phase 1 studies with brain-penetrant Tyrosine Kinase 2/Janus Kinase 1 (TYK2/JAK1) inhibitor, BHV-8000, and Transient Receptor Potential Melastatin 3 (TRPM3) antagonist, BHV-2100, programs advancing Total of three late stage, pivotal clinical trials ongoing with taldefgrobep alfa in SMA and troriluzole in OCD 20 abstracts, including 8 oral presentations and 12 posters, featured at the American Academy of Neurology (AAN) Annual Meeting, including recognition of BHV-2100 (TRPM3 antagonist) as AAN Abstract of Distinction in the pain category; breadth of presentations highlights Biohaven's leadership in neuroscience and immunoscience as well as extensive development programs evaluating novel therapies to treat neurological diseases, with abstracts covering programs including Kv7 ion channel modulation, MoDEs™, TYK2/JAK1 inhibition, glutamate modulation, myostatin inhibition, and TRPM3 antagonism NEW HAVEN, Conn.

Biohaven Reports First Quarter 2024 Financial Results and Recent Business Developments

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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.

Biohaven's Bounce Back: A Missed Call Turns Bullish (Rating Upgrade)

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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

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

Is Biohaven Ltd. (BHVN) Outperforming Other Medical Stocks This Year?

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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Biohaven Ltd. (BHVN) Is a Great Choice for 'Trend' Investors, Here's Why

Are Medical Stocks Lagging Biohaven Ltd. (BHVN) This Year?

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Here's Why Momentum in Biohaven Ltd. (BHVN) Should Keep going

- 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.

News for Biohaven Pharmaceutical Hld Stock (BHVN)