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.

Cash, cash equivalents, marketable securities and restricted cash as of October 2, 2024 totaled approximately $642 million Achieved positive topline trial results from pivotal trial with troriluzole in spinocerebellar ataxia (SCA) Troriluzole 200 mg QD dosed orally in patients with SCA met the study's primary endpoint on the change from baseline on the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes Statistically significant superiority achieved on 9 consecutive, prespecified primary and secondary endpoints Both the study protocol and statistical analysis plan were submitted to, and reviewed by, the U.S. Food and Drug Administration (FDA) prior to topline data analysis Study designed in discussion with the FDA and utilized Phase 3 data and an external control of matched, untreated SCA subjects from the U.S. Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) in accordance with the FDA's Guidance on Real-World Evidence (RWE) of effectiveness CRC-SCA external control included contemporaneous natural history data gathered from 2010-2024 Planned New Drug Application (NDA) re-submission in 4Q 2024 Completed clarification meeting with CHMP Rapporteurs in 4Q 2024 and MAA documents are being updated to include the new positive BHV4157-206-RWE study data with broader indication to include all SCA genotypes Taldefgrobep alfa, a myostatin-inhibitor, Phase 3 topline data in spinal muscular atrophy (SMA) in 4Q 2024 and Phase 2 trial protocol in obesity expected in 4Q 2024 Advancing extracellular Molecular Degrader of Extracellular Protein (MoDE) programs 3 additional investigational agents expected to enter Phase 1 studies in the next quarter Anticipate Phase 1 update for BHV-1300, including subcutaneous formulation, before year-end Broad progress with TRPM3 antagonist Initiated pivotal Phase 2 trial evaluating BHV-2100, a TRPM3 antagonist, in the acute treatment of migraine Initiated separate proof of concept study with BHV-2100 in neuropathic pain Patient enrollment continues across 5 Phase 2/3 trials with Kv7 activator, BHV-7000, in epilepsy and mood disorders (bipolar and major depressive disorder (MDD)) with potential for multiple data readouts in 2025 Continued progress with antibody drug conjugate (ADC) portfolio BHV-1510 currently dosing cancer patients in Phase 1/2 study, advancing towards combination dosing of BHV-1510 with Libtayo® in 4Q 2024 NEW HAVEN, Conn. , Nov. 12, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Reports Third Quarter 2024 Financial Results and Recent Business Developments

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

Biohaven Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares

NEW HAVEN, Conn. , Oct. 1, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Announces Pricing of $250 Million Public Offering of Common Shares

NEW HAVEN, Conn. , Sept. 30, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Announces Proposed Public Offering of Common Shares

Biohaven initiated a pivotal Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine BHV-2100 is a potential first-in-class, potent, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist— a novel, highly selective, and non-opioid investigational treatment being developed for migraine and other pain disorders Despite recent treatment advances, migraine remains a leading cause of disability and burden, impacting 40 million people in the US and 1 billion world-wide NEW HAVEN, Conn. , Sept. 30, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Initiates Pivotal Trial of Novel Investigational Drug for Treatment of Migraine

The pivotal BHV4157-206-RWE study evaluating Biohaven's pipeline candidate, troriluzole, for treating spinocerebellar ataxia meets its primary endpoint.

BHVN Stock Up as Rare Neurological Disease Study Meets Primary Goal

Biohaven Ltd. NYSE: BHVN has taken center stage in the biopharmaceutical sector after releasing positive results from its Phase 3 clinical trial for troriluzole, a drug being developed to treat spinocerebellar ataxia (SCA).

Biohaven Stock Soars on Drug Trial Results: Time to Jump In?

Biohaven Ltd. reported positive results from a pivotal study using troriluzole for the treatment of patients with spinocerebellar ataxia; the Drug achieved 50% to 70% of slowing of disease progression over 3 years. With positive data on hand from the phase 3 study using troriluzole for patients with spinocerebellar ataxia, an NDA submission is planned for Q4 of 2024. Troriluzole is also being explored for patients with obsessive compulsive disorder in two phase 3 studies; Data from these studies are expected before the end of 2024 and the 1st half of 2025.

Biohaven: Positive SCA Treatment Data Leads To Q4 2024 NDA Submission Catalyst

Biohaven (BHVN) shares soared 15% Monday after the biotech firm announced positive results from a study of its experimental treatment for a rare neurological condition.

Biohaven Stock Soars on Positive Results for Rare Neurological Disease Drug

Monday, Biohaven Ltd. BHVN released topline results from pivotal Study BHV4157-206-RWE demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after three years of treatment.

Biohaven Stock Spikes After Drug Candidate To Treat Rare Neurodegenerative Disease Shows Promise

Shares of Biohaven climbed 13% premarket on Monday after the biotech company said its treatment for a rare neurological disorder slowed progress of the condition in a clinical trial.

Biohaven's stock surges as treatment slows progress of neurological disorder

Biohaven stock jumped Monday after the company's experimental drug slowed progression in a rare disease with no approved treatments.

Biohaven Surges After Delaying Progression By Up To 70% In A Rare Disease

Biohaven has met the main goal in a study evaluating its drug in patients with an inherited disease that mainly affects the brain, the company said on Monday.

Biohaven's genetic disease drug meets main trial goal

Troriluzole 200 mg dosed orally, once daily, in patients with SCA met the study's primary endpoint on the change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes. Troriluzole also showed statistically significant superiority after both 1 and 2 years of treatment.

Biohaven Achieves Positive Topline Results in Pivotal Study of Troriluzole in Spinocerebellar Ataxia (SCA)

Conference call and webcast to be held Monday, September 23, at 8:30am ET  NEW HAVEN, Conn. , Sept. 20, 2024 /PRNewswire/ -- Biohaven Ltd.

Biohaven Announces Conference Call to Discuss Topline Pivotal Study Results in Spinocerebellar Ataxia

Cash, cash equivalents, marketable securities and restricted cash totaled approximately $440 million on June 30, 2024 Biohaven's Molecular Degrader of Extracellular Proteins (MoDE™) platform advancing multiple new targets and reported positive interim data from its lead investigational drug in an ongoing Phase 1 study of BHV-1300: The Company reported dose-dependent and rapid IgG reductions in its ongoing Phase 1 trial with its lead investigational degrader BHV-1300 No serious adverse events (SAEs) reported with BHV-1300 to date; most adverse events (AEs) were mild, deemed unrelated to study drug and resolved spontaneously Phase 1 study also completed an assessment of an optimized subcutaneous (SC) formulation of BHV-1300 that demonstrated approximately a 44% higher than expected exposure compared to the dose-equivalent intravenous formulation previously studied; this new human data further confirms feasibility of convenient self-administered SC auto-injector and the SC formulation was not associated with injection site reactions Degrader platform expected to deliver 3 INDs for new MoDE programs before year-end in addition to continued data from SAD/MAD with BHV-1300 Biohaven's beta-1 adrenergic receptor (β1AR) autoantibody targeting MoDE, BHV-1600, granted INTERACT meeting with FDA in 2H 2024 regarding development program for dilated cardiomyopathy Advancing novel ion channel program targeting Kv7 activation and TRPM3 antagonism across multiple neurological, pain and neuropsychiatric disease indications: 5 Phase 2/3 trials with BHV-7000 underway in epilepsy and mood disorders 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 acute migraine and proof-of-concept (POC) study in pain in 2H 2024 Taldefgrobep alfa, a myostatin-inhibitor, progressing on track with Phase 3 topline data in spinal muscular atrophy (SMA) and Phase 2 trial initiation in obesity expected in 2H 2024 Taldefgrobep alfa has demonstrated direct effects on reducing adipose tissue (including lipid storage and mitochondrial content) independent of increases in muscle mass In a MAD study, conducted in healthy adults, taldefgrobep alfa (45 mg SC QW) produced significant reductions in total body fat while increasing total body lean mass Preclinical data released at the 2024 American Diabetes Association conference demonstrated that taldefgrobep alfa, as a monotherapy or in combination with a GLP-1 agonist, demonstrated significant reductions in fat and total body weight. Taldefgrobep alfa-treated animals showed significant increases in lean muscle, despite co-administration with a GLP-1 receptor agonist Tyrosine Kinase 2/Janus Kinase 1 (TYK2/JAK1) selective inhibitor, BHV-8000, completed Phase 1 and confirmed biomarker target engagement with reductions in inflammatory markers and demonstrated central nervous system penetration with confirmed cerebrospinal fluid (CSF) target exposures in healthy subjects Advancing registrational programs for Parkinson's disease and prevention of Amyloid-Related Imaging Abnormalities (ARIA) following interactions with the FDA Expect interim data analysis from second ongoing Phase 3 OCD trial with troriluzole in 2H 2024; topline data from first Phase 3 OCD trial expected in 1H 2025 SCA interactions with troriluzole filing in Europe ongoing and constructive interactions in the US with the FDA New real-world evidence (RWE) protocol, incorporating feedback from the FDA, assessing 3-years of treatment with troriluzole expected to deliver topline results in 2H 2024 Biohaven antibody drug conjugate (ADC) portfolio positioned to deliver differentiated profiles and address unmet needs in oncology: BHV-1510 currently dosing cancer patients in Phase1/2 study and now advancing towards combination with Libtayo® by 4Q 2024 Portfolio of multiple advanced nonclinical BHVN ADCs demonstrate improved plasma stability and in vitro/in vivo differentiation NEW HAVEN, Conn.

Biohaven Reports Second Quarter 2024 Financial Results and Recent Business Developments

Results from phase 3 RESILIENT study, using taldefgrobep alfa for the treatment of patients with spinal muscular atrophy, expected in the 2nd half of 2024. The global spinal muscular atrophy treatment market is projected to reach $8.4 billion by 2032. Preclinical model testing showed that myostatin inhibitor taldefgrobep alfa + GLP-1 inhibitor was able to show greater reductions in body weight and fat loss, compared to that of GLP-1 alone.

Biohaven: Taldefgrobep Alfa Might Have A Place Beyond SMA Treatment

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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.

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