Biohaven .(BHVN)

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Biohaven .(BHVN) - 2024 Q4 - Annual Results
2025-03-03 21:26
Exhibit 99.1 Biohaven Reports Recent Business Developments and Fourth Quarter and Full Year 2024 Financial Results • Announced acceptance and Priority Review by the United States Food and Drug Administration (FDA) of the new drug application (NDA) for troriluzole in all-genotype spinocerebellar ataxia; expected Prescription Drug User Fee Act (PDUFA) date in 3Q 2025. • Cash, cash equivalents, marketable securities and restricted cash as of December 31, 2024 totaled approximately $489 million. • Reported posi ...
Biohaven .(BHVN) - 2024 Q4 - Annual Report
2025-03-03 21:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ____________________________________________________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-41477 Biohaven Ltd. (Exact Name of Registran ...
Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300
Prnewswire· 2025-03-03 12:31
Core Insights - Biohaven Ltd. has reported significant success with its investigational drug BHV-1300, a potential first-in-class IgG1,2,4 selective degrader, which has shown rapid and deep reductions in total IgG levels, indicating its potential for treating autoimmune diseases [1][3][7] Group 1: BHV-1300 Efficacy and Mechanism - In a four-week Phase 1 study, subcutaneous administration of BHV-1300 at a dose of 1000 mg weekly achieved reductions in total IgG of up to 84%, with a median reduction of 80% [2][3] - The drug selectively targets IgG1,2,4 while sparing IgG3, which is crucial for maintaining immune defense against infections [3][5] - BHV-1300 demonstrated progressive reductions in IgG levels within hours of each dose, with sustained effects over the study period [3][4] Group 2: Safety and Tolerability - BHV-1300 has been reported as safe and well-tolerated, with no clinically significant increases in liver enzymes or bilirubin, and no serious adverse events noted during the study [4][6] - Most adverse events were mild and self-resolving, with no discontinuations due to the study drug [4][6] Group 3: Future Development Plans - Based on the promising results, Biohaven plans to initiate a Phase 2 study in Graves' disease in mid-2025, with additional studies in other autoimmune diseases to follow [3][6] - The company aims to customize treatment approaches based on the depth and speed of IgG lowering achievable with BHV-1300 [3][4] Group 4: Market Context and Unmet Needs - Graves' disease affects approximately 3 million individuals in the US and 80 million globally, highlighting a significant unmet need for effective treatments that do not lead to permanent hypothyroidism or other severe side effects [6][7] - Current treatments for Graves' disease have remained unchanged for 70 years, creating an opportunity for innovative therapies like BHV-1300 to disrupt the existing treatment paradigm [6][7]
Biohaven Reports Recent Business Developments and Fourth Quarter and Full Year 2024 Financial Results
Prnewswire· 2025-03-03 12:30
Announced acceptance and Priority Review by the United States Food and Drug Administration (FDA) of the new drug application (NDA) for troriluzole in all-genotype spinocerebellar ataxia; expected Prescription Drug User Fee Act (PDUFA) date in 3Q 2025. Cash, cash equivalents, marketable securities and restricted cash as of December 31, 2024 totaled approximately $489 million. Reported positive degrader data with multiple doses of BHV-1300 achieving up to 84% reduction of total IgG, with a median reduction o ...
Biohaven's Exciting Year Of Catalysts
Seeking Alpha· 2025-02-28 10:14
Group 1 - Biohaven, after its acquisition by Pfizer, has seen a significant increase in valuation, rising from an approximate $7 share price and a $300 million valuation [1] - The new venture led by Vlad Coric has demonstrated a steady growth trajectory in its market valuation [1] Group 2 - No additional relevant content available [2]
Biohaven: NDA Review Of Troriluzole Isn't Only 2025 Catalyst On Deck
Seeking Alpha· 2025-02-11 22:47
Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings [1]. Group 2: Analyst Background - The author of the article runs the Biotech Analysis Central service and emphasizes the depth of analysis provided for healthcare investors [2]. - The article does not indicate any personal investment positions in the companies discussed, ensuring an unbiased perspective [3].
Biohaven to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Prnewswire· 2025-01-07 22:54
Company Overview - Biohaven Ltd. is a biopharmaceutical company focused on discovering, developing, and commercializing treatments in key therapeutic areas such as immunology, neuroscience, and oncology [2] - The company is advancing an innovative portfolio of therapeutics, utilizing proven drug development experience and proprietary drug development platforms [2] Therapeutic Areas and Programs - Biohaven's clinical and nonclinical programs include: - Kv7 ion channel modulation for epilepsy and mood disorders - Extracellular protein degradation for immunological diseases - TRPM3 antagonism for migraine and neuropathic pain - TYK2/JAK1 inhibition for neuroinflammatory disorders - Glutamate modulation for obsessive-compulsive disorder (OCD) and spinocerebellar ataxia (SCA) - Myostatin inhibition for neuromuscular and metabolic diseases, including spinal muscular atrophy (SMA) and obesity - Antibody recruiting bispecific molecules and antibody drug conjugates for cancer [2] Upcoming Events - Vlad Coric, M.D., Chairman and CEO of Biohaven, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 8:15 am (PT) [1]
Biohaven Reports Positive Phase 1 Degrader Data, Achieving Deep Targeted IgG Reductions in the Lowest Subcutaneous Dose Tested; Announces NDA Submission for Troriluzole in SCA and Provides Other Key Program Updates
Prnewswire· 2024-12-16 12:30
Core Insights - Biohaven's BHV-1300 has demonstrated significant efficacy in reducing targeted IgG levels by over 60% in the lowest subcutaneous dose tested during the ongoing multiple ascending dose (MAD) study, with sustained pharmacodynamic effects over four weeks [1] - The safety profile of BHV-1300 is strong, with no clinically significant effects on liver function or cholesterol levels, and all adverse events reported were mild and resolved [1][2] - Biohaven is advancing its MoDE platform with the regulatory acceptance of three next-generation degraders, including BHV-1400 and BHV-1600, targeting specific immune-mediated diseases while preserving healthy antibodies [3][4] Group 1: BHV-1300 Development - BHV-1300 achieved rapid and deep reductions in IgG levels, indicating its potential for treating IgG-mediated immune diseases [2] - The optimized subcutaneous formulation of BHV-1300 shows less inter-patient variability compared to previous intravenous formulations [1] - The ongoing MAD study aims to explore the full range of IgG reductions possible with BHV-1300 for various disease indications [1] Group 2: MoDE Technology and Future Developments - Biohaven's MoDE technology allows for selective degradation of pathogenic antibodies while preserving IgG3, crucial for immune response [2] - BHV-1400 targets galactose deficient IgA1 for IgA nephropathy, a rare disease affecting approximately 60,000 individuals in the U.S., with a focus on preserving the immune system [4] - BHV-1600 is designed to degrade autoantibodies related to peripartum cardiomyopathy, a rare heart failure condition with no current approved therapies [5][6] Group 3: Regulatory and Clinical Milestones - Biohaven has submitted a new drug application (NDA) for troriluzole, aimed at treating spinocerebellar ataxia (SCA), a rare neurodegenerative disease affecting around 15,000 people in the U.S. [8] - The pivotal BHV-7000 Phase 2/3 trial for bipolar disorder has completed enrollment ahead of schedule, reflecting the urgent need for new treatments in this area [9] - Biohaven's IND for BHV-1310, an optimized IgG degrader, is expected to begin human dosing in Q1 2025 [7]
Scholar Rock Stock Jumps As Rival Biohaven's Muscle-Wasting Drug Flunks Pivotal Study
Benzinga· 2024-11-25 16:51
Core Insights - Biohaven Ltd. updated the development programs for taldefgrobep alfa in Spinal Muscular Atrophy (SMA) and obesity, showing clinically meaningful improvements in motor function but not statistically significant on the primary outcome at 48 weeks compared to placebo plus standard of care [1] - Efficacy signals were observed in specific subgroups, particularly those defined by age, ambulatory status, background therapy, and baseline myostatin levels, with 35% of subjects having no measurable myostatin at baseline [2] - The largest study population, predominantly Caucasian (87%), showed a 2.2-point improvement in motor function with taldefgrobep compared to a 1.1-point improvement in the placebo group, while non-Caucasian subjects did not show significant separation from placebo [3] Taldefgrobep in Obesity - Taldefgrobep demonstrated a greater reduction in total body fat mass compared to the placebo plus standard of care arm, with a statistically significant p-value of 0.008 [4] - The treatment also showed numerically larger increases in lean muscle mass and bone density compared to the placebo group [4] - Biohaven plans to accelerate clinical development for taldefgrobep in Q4 2024, focusing on a self-administered autoinjector for adults with overweight and obesity [4] Market Reaction - Following the trial update, Scholar Rock Holding's stock increased by 33.2% to $39.85, while Biohaven's stock rose by 0.91% to $46.01 [5][6]
Cassava Sciences, Biohaven And Other Big Stocks Moving Lower In Monday's Pre-Market Session
Benzinga· 2024-11-25 13:32
Core Viewpoint - U.S. stock futures are up, with Dow futures increasing by over 300 points, while shares of Cassava Sciences fell sharply after disappointing Phase 3 study results for Simufilam in Alzheimer's patients [1]. Company Summaries - Cassava Sciences, Inc. experienced a significant decline in share price, dropping 85.6% to $3.82 in pre-market trading following the announcement that Simufilam did not show a significant reduction in cognitive decline compared to placebo in the ReThink-ALZ Phase 3 study [2][1]. - Centessa Pharmaceuticals PLC saw its shares tumble 12% to $15.00 in pre-market trading after reporting a quarterly loss of $0.37 per share [4]. - Biohaven Ltd. shares fell 11% to $40.60 after the treatment arm of the RESILIENT SMA study did not statistically separate from the placebo group at Week 48 [4]. - ZIM Integrated Shipping Services Ltd. shares dipped 6.9% to $22.15 despite reporting better-than-expected third-quarter financial results and raising FY24 adjusted EBIT and EBITDA guidance [4]. - i3 Verticals, Inc. shares declined 6.6% to $22.11 after posting disappointing quarterly results [4]. - ChromaDex Corporation shares fell 5.9% to $7.00 in pre-market trading [4]. - Fitell Corporation shares declined 4.9% to $24.00 after gaining around 6% on the previous trading day [4]. - Logility Supply Chain Solutions, Inc. shares fell 4.4% to $9.31 after reporting worse-than-expected second-quarter revenue results and issuing FY25 revenue guidance below estimates [4]. - Kingsoft Cloud Holdings Limited shares fell 4.3% to $6.90 after a significant jump of around 25% on the previous trading day, despite reporting a fiscal third-quarter 2024 revenue of 1.89 billion Chinese yuan ($268.7 million), which was up 16.0% year-on-year and exceeded analyst expectations [4].