Biohaven Stock Price, News & Analysis

Biohaven (NYSE: BHVN) priced an underwritten public offering of 23,333,334 common shares at $7.50 per share, with gross proceeds of approximately $175 million. The underwriters have a 30-day option to buy up to 3,500,000 additional shares at the public price less discounts and commissions.

The offering is expected to close on November 13, 2025, subject to customary conditions. Biohaven intends to use net proceeds for general corporate purposes. The shares will be issued under an effective Form S-3 shelf registration.

Biohaven (NYSE: BHVN) announced on November 11, 2025 that it has commenced an underwritten public offering of $150 million of common shares, with a 30-day underwriter option to purchase up to an additional $22.5 million of shares at the public offering price, less underwriting discounts and commissions.

The offering is subject to market and other conditions and may not be completed. All shares will be sold by Biohaven and will be issued under an effective Form S-3 shelf registration. Net proceeds are intended for general corporate purposes. J.P. Morgan and Goldman Sachs are book-running managers.

Biohaven (NYSE: BHVN) reported Q3 2025 results and strategic reprioritization on Nov 10, 2025. The company recorded a GAAP net loss of $173.4M ($1.64/share) and a non-GAAP adjusted net loss of $155.9M ($1.47/share). Cash, cash equivalents, marketable securities and restricted cash totaled $263.8M as of Sept 30, 2025. Biohaven initiated cost optimization to focus on three late-stage value-driving programs: opakalim (Kv7 activator for focal epilepsy and MDD), lead TRAP/MoDE degraders (BHV-1400 for IgAN, BHV-1300 for Graves' disease) and taldefgrobep alfa (myostatin-activin inhibitor for obesity and SMA).

Management expects ~60% reduction in annual direct R&D spend and milestone timing including top-line MDD results in 4Q 2025, focal epilepsy results in 1H 2026, and a Phase 2 obesity start in 4Q 2025.

Biohaven (NYSE: BHVN) received an FDA Complete Response Letter (CRL) for the NDA seeking approval of VYGLXIA (troriluzole) for spinocerebellar ataxia (SCA) on Nov 5, 2025.

Key data in the filing included a 3‑year real‑world evidence study showing a 50–70% slowing of SCA progression and a safety analysis showing >50% reduction in fall risk versus placebo, but FDA raised concerns about RWE/external control bias and study design.

Biohaven will request a meeting with FDA, continue an expanded access program, and is cutting non‑priority R&D to prioritize three late‑stage programs while targeting an ≈60% reduction in annual direct R&D spend.

Biohaven (NYSE: BHVN) reported Q2 2025 financial results and business developments, highlighting a cash position of $408.2 million as of June 30, 2025. Key developments include promising clinical results across multiple platforms: MoDE degrader BHV-1300 achieved up to 87% IgG reduction, while TRAP degrader BHV-1400 demonstrated over 80% Gd-IgA1 reductions.

The company's oncology program showed early success with BHV-1510, their Trop2 ADC, achieving tumor reduction in all initial 6 patients when combined with cemiplimab. Additionally, Biohaven initiated a pivotal Phase 2/3 study for BHV-8000 in Parkinson's disease and awaits FDA decision on VYGLXIA for spinocerebellar ataxia in Q4 2025.

Financial results showed R&D expenses of $184.4 million, down from $314.8 million in Q2 2024, with a net loss of $198.1 million ($1.94 per share) compared to $319.8 million ($3.64 per share) in the prior year.

Biohaven (NYSE: BHVN) has initiated a global Phase 2/3 clinical trial for BHV-8000, a first-in-clinic, brain-penetrant TYK2/JAK1 inhibitor targeting early Parkinson's disease (PD). The study will evaluate 550 patients across 185 sites in 13 countries. BHV-8000 aims to treat neuroinflammation and immune dysregulation in PD, for which there are currently no approved disease-modifying therapies. The trial will test two dose levels (10mg and 20mg) against placebo. Phase 1 results showed the drug was safe and well-tolerated, with no serious adverse events and demonstrated significant reductions in inflammatory biomarkers. The drug achieved ~50% plasma exposure in the CNS at clinical doses. This development is crucial as global PD prevalence is expected to double by 2050, affecting over 10 million people currently.

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.