Welcome to our dedicated page for Biohaven news (Ticker: BHVN), a resource for investors and traders seeking the latest updates and insights on Biohaven stock.
Biohaven Ltd. (NYSE: BHVN) is a clinical-stage biopharmaceutical company whose news flow centers on progress across its immunology, obesity, neuroscience and oncology pipelines. Company updates frequently cover clinical trial readouts, regulatory interactions, financing events and scientific presentations that shape the outlook for its drug development platforms.
Investors and followers of BHVN news can expect detailed announcements on Biohaven’s Kv7 ion channel modulation programs, including opakalim in refractory focal epilepsy and major depressive disorder, as well as updates on the MoDE™ and TRAP™ extracellular degrader platforms targeting immune-mediated diseases such as IgA nephropathy and Graves’ disease. News releases also highlight the advancement of taldefgrobep alfa, a myostatin-activin pathway inhibitor in obesity and SMA, and BHV-8000, a brain-penetrant TYK2/JAK1 inhibitor in pivotal studies for early Parkinson’s disease.
Biohaven’s oncology news often focuses on early clinical data from its next-generation antibody-drug conjugates, including BHV-1510, a Trop2-directed ADC, and BHV-1530, an FGFR3-directed ADC, with reports of tumor responses, safety profiles and combination strategies with checkpoint inhibitors. Additional coverage includes regulatory milestones such as the FDA Complete Response Letter for VYGLXIA (troriluzole) in spinocerebellar ataxia and the company’s stated plans for further regulatory dialogue.
Capital markets and corporate updates—such as public offerings of common shares, at-the-market transactions, portfolio reprioritization and cost-optimization measures—also feature prominently in BHVN news. Readers who monitor this stream gain insight into Biohaven’s evolving clinical strategy, key upcoming milestones and how the company allocates resources across its late-stage programs.
Biohaven (BHVN) has reported significant developments and financial results for Q4 and full year 2024. The company maintains a strong financial position with $489 million in cash and equivalents as of December 31, 2024.
Key highlights include FDA's acceptance and Priority Review of troriluzole for spinocerebellar ataxia with a PDUFA date in Q3 2025. Their degrader program showed promising results with BHV-1300 achieving up to 84% reduction in total IgG through subcutaneous weekly dosing.
The company is advancing multiple clinical programs across immunology, neuroscience, and oncology. Notable developments include:
- Positive Phase 1 results for BHV-1400 in IgA Nephropathy
- Ongoing Phase 2/3 studies for BHV-7000 in depression and epilepsy
- Planned Phase 2 study initiation for taldefgrobep alfa in obesity in 1H 2025
- Development of multiple antibody drug conjugates (ADCs) for cancer treatment
Biohaven (NYSE: BHVN) announced FDA acceptance and Priority Review of its New Drug Application (NDA) for troriluzole in treating Spinocerebellar Ataxia (SCA), a rare genetic neurodegenerative disease with no current treatment. The FDA's decision is expected in Q3 2025.
The NDA submission is supported by positive results from a real-world evidence study showing troriluzole demonstrated a 50-70% slower rate of decline in SCA progression over 3 years, representing a 1.5-2.2 years delay in disease progression. The drug showed statistical significance across 9 consecutive endpoints.
If approved, troriluzole would become the first FDA-approved treatment for SCA. Biohaven plans to commercialize the drug in the US in 2025. The company has received Fast-Track and Orphan Drug Designations from both FDA and European Medicines Agency, where a marketing authorization application is under review.
Biohaven highlighted significant progress across its portfolio at the 43rd Annual J.P. Morgan Healthcare Conference, featuring positive Phase 1 data for BHV-1400, its IgA nephropathy treatment. The first and lowest dose (125mg) achieved rapid lowering of Gd-IgA1 with a 60% median reduction within four hours and over 70% reduction within eight hours.
Key developments include:
- Advancement of MoDE platform and TRAP degraders across multiple programs
- Progress in ion channel programs for bipolar disorder, depression, epilepsy, and pain
- Expansion of antibody drug conjugate portfolio in oncology
- Development of BHV-1300 for Graves' Disease showing >60% IgG reduction
- Planned pivotal trials for BHV-8000 in Parkinson's and Alzheimer's disease in 2025
- NDA submission for troriluzole in SCA genotypes
Biohaven (NYSE: BHVN) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's Chairman and Chief Executive Officer, Vlad Coric, M.D., is scheduled to deliver a presentation at The Westin St. Francis Hotel in San Francisco, California. The presentation will take place on Monday, January 13, 2025, at 8:15 am Pacific Time.
Biohaven (NYSE: BHVN) reported significant progress across multiple clinical programs. BHV-1300 achieved >60% reduction in targeted IgG at the lowest subcutaneous dose tested, with sustained effects over four weeks and no serious adverse events. The company submitted an NDA for troriluzole in spinocerebellar ataxia (SCA) and completed enrollment in the BHV-7000 Phase 2/3 bipolar trial ahead of schedule.
The company expanded its molecular degraders program with three new drug candidates: BHV-1400 for IgA nephropathy, BHV-1600 for autoimmune cardiomyopathy, and BHV-1310 for IgG mediated diseases. Biohaven partnered with Ypsomed to develop an autoinjector for BHV-1300 self-administration.
Biohaven presented expanded safety data for BHV-7000, their novel anti-seizure medication, at the American Epilepsy Society 2024 Annual Meeting. The Phase 1 multiple ascending dose studies demonstrated excellent tolerability of the once-daily extended-release formulation without typical CNS adverse effects associated with other anti-seizure medications.
The drug showed favorable safety at doses up to 120 mg daily for 15 days, exceeding the doses being evaluated in ongoing Phase 2/3 trials (up to 75 mg daily). Studies revealed low rates of CNS-related adverse events, with no somnolence or cognitive disturbances reported. Additional nonclinical data showed BHV-7000's effectiveness in reducing neuronal activity and rescuing current density in KCNQ2 variants.
Biohaven reported mixed results from its RESILIENT SMA study of taldefgrobep alfa. While the treatment showed clinically meaningful improvements in motor function, it did not achieve statistical significance at Week 48 compared to placebo. However, positive results were observed in specific subgroups, particularly among Caucasian patients (87% of study population) and those with measurable baseline myostatin levels. The drug demonstrated significant effects on body composition, including reduced fat mass (p=0.008) and increased lean muscle mass. Based on these results, Biohaven plans to advance taldefgrobep into a Phase 2 obesity study in Q4 2024. The treatment was well-tolerated with no serious adverse events.
Biohaven reported its Q3 2024 financial results and recent business developments. As of October 2, 2024, the company had $642 million in cash and equivalents. Key achievements include positive topline results from a pivotal trial of troriluzole in spinocerebellar ataxia (SCA) and the initiation of a Phase 2 trial for BHV-2100 in acute migraine. Troriluzole met primary and secondary endpoints, showing significant improvements in SCA patients over three years. The company plans to submit an NDA in Q4 2024. Recent public offering raised $269.9 million. R&D expenses increased to $157.6 million, partly due to advancing clinical trials, while net loss widened to $160.3 million. Upcoming milestones include Phase 3 data for taldefgrobep alfa in SMA and continued progress across various programs.
Biohaven (NYSE: BHVN) has successfully closed its underwritten public offering of 6,052,631 common shares, including the full exercise of the underwriters' option to purchase an additional 789,473 shares. The offering was priced at $47.50 per share, resulting in gross proceeds of approximately $287.5 million before deducting underwriting discounts, commissions, and offering expenses.
The company intends to use the net proceeds for general corporate purposes. The offering was managed by joint lead book-running managers J.P. Morgan, Morgan Stanley, Jefferies, and TD Cowen. The shares were issued under an effective shelf registration statement on Form S-3, and the offering was made through a prospectus supplement and accompanying prospectus.
Biohaven (NYSE: BHVN) has announced the pricing of its public offering of 5,263,158 common shares at $47.50 per share. The company expects to raise approximately $250 million in gross proceeds before deducting underwriting discounts and expenses. Biohaven has also granted underwriters a 30-day option to purchase up to an additional 789,473 shares at the public offering price. The offering is set to close on October 2, 2024, subject to customary conditions.
The company plans to use the net proceeds for general corporate purposes. J.P. Morgan, Morgan Stanley, Jefferies, and TD Cowen are acting as joint lead book-running managers for the offering. The shares will be issued under an effective shelf registration statement on Form S-3.