Biohaven Stock Price, News & Analysis

Biohaven (NYSE: BHVN) announced positive Phase 1 data for two key drug candidates at its R&D Day. BHV-1400, a first-in-class TRAP degrader for IgA nephropathy (IgAN), achieved up to 81% reduction in Galactose-deficient IgA1 (Gd-IgA1) with a single subcutaneous dose, maintaining selectivity without affecting other antibodies. The company plans to initiate pivotal trials for IgAN in 2026. Additionally, BHV-1300, their MoDE degrader targeting IgG, demonstrated up to 87% reduction in IgG levels in Phase 1 studies, with median maximum reductions of 83% within 18 days. Biohaven plans to begin pivotal trials for Graves' Disease in 2H 2025. Both drug candidates showed favorable safety profiles with mostly mild, self-resolving adverse events and no serious safety concerns.

Biohaven (NYSE: BHVN) presented promising updates on its oncology programs at its 2025 R&D Day. The company's Trop2 antibody drug conjugate (ADC) BHV-1510 showed encouraging clinical activity both as monotherapy and combined with Regeneron's cemiplimab. Key highlights include:

- Tumor reduction in all 6 patients treated with BHV-1510/cemiplimab combination - Favorable safety profile with manageable toxicity - No cases of interstitial lung disease and low gastrointestinal toxicity rates

Additionally, Biohaven announced dosing of the first patient with BHV-1530, their novel FGFR3-directed ADC. This potential first-in-class treatment targets FGFR3-driven cancers, including urothelial cancers. The company is also advancing collaborations with Merus and GeneQuantum on preclinical ADC programs using their proprietary TopoIx payload technology.

The FDA has extended the PDUFA date for Biohaven's (NYSE: BHVN) troriluzole new drug application (NDA) for treating spinocerebellar ataxia (SCA) by three months to Q4 2025. The extension allows for a full review of recent submissions, and the FDA plans to hold an advisory committee meeting. No new concerns were raised.

Troriluzole, which has received Fast-Track, Orphan Drug Designation, and Priority Review from the FDA, could become the first FDA-approved treatment for SCA, a rare genetic neurodegenerative disease. Clinical data shows troriluzole, a once-daily oral pill, slows disease progression by 50-70% and reduces fall risk. The mid-cycle review revealed no major safety concerns, and a Risk Evaluation and Mitigation Strategy (REMS) appears unnecessary.

Biohaven (NYSE: BHVN) reported Q1 2025 financial results and business updates. Key highlights include: $518 million in cash and equivalents as of April 30, 2025, bolstered by a $600 million non-dilutive capital agreement with Oberland Capital. The company completed FDA mid-cycle review for troriluzole's NDA for spinocerebellar ataxia treatment, with PDUFA date expected in Q3 2025. R&D expenses increased to $187.6 million vs $156.0 million in Q1 2024. Net loss was $221.7 million ($2.17 per share) compared to $179.5 million ($2.20 per share) in Q1 2024. The company presented 13 abstracts at AAN, showcasing their neuroscience portfolio. Multiple clinical milestones are expected across their pipeline in 2025-2026, including Phase 1 studies completion for three compounds in 1H 2025 and pivotal data readouts for various programs.

Biohaven (NYSE: BHVN) has secured a significant non-dilutive investment of up to $600 million from Oberland Capital Management The deal structure includes:

- $250 million to be funded at closing by April 30, 2025
- $150 million available upon achieving regulatory milestones for troriluzole
- Up to $200 million by mutual agreement for strategic acquisitions

The investment, structured as a Note Purchase Agreement (NPA), will support ongoing clinical trials and commercialization efforts, particularly for troriluzole in treating spinocerebellar ataxia (SCA), a rare genetic condition with no available treatments. In exchange, Oberland Capital will receive regulatory milestone payments through 2030 and tiered single-digit royalties on troriluzole global sales for up to 10 years.

Biohaven (NYSE: BHVN) announced its presentation of 13 abstracts at the 2025 American Academy of Neurology Annual Meeting in San Diego (April 5-9, 2025). The presentations include 3 oral and 10 poster presentations showcasing the company's neuroscience pipeline across multiple development programs.

The presentations focus on various therapeutic areas including Kv7 ion channel modulation, extracellular protein degradation, TRPM3 antagonism, TYK2/JAK1 inhibition, and glutamate modulation. Key highlights include data on BHV-8000 for Parkinson's Disease, BHV-2100 for pain and migraine, and BHV-1310 for IgG reduction.

The company's Chief Medical Officer, Dr. Irfan Qureshi, emphasized their commitment to developing first-in-class therapies for neurological disorders with inadequate or no treatment options, anticipating critical value-creating milestones throughout 2025.

Biohaven (NYSE: BHVN) has reported positive Phase 1 data for BHV-1300, a potential first-in-class IgG1,2,4 selective degrader. The subcutaneous administration achieved up to 84% reduction in total IgG with a median reduction of 80% after weekly 1000 mg dosing.

BHV-1300 demonstrated rapid, deep, and sustained reductions in IgG levels within hours of each weekly dose. The drug was well-tolerated up to 2000 mg doses with mostly mild, self-resolving adverse events and no serious safety concerns. The treatment specifically targets IgG1,2,4 while sparing IgG3, maintaining key immune defenses.

Based on these results, Biohaven plans to initiate a Phase 2 study in Graves' disease in mid-2025. Graves' disease affects 3 million people in the US and 80 million globally. The company's MoDE™ technology allows for customization of IgG lowering across different disease indications.

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.