Biohaven (BHVN) Company Report

Biohaven Ltd. announced that its Phase 2 proof-of-concept study for BHV-7000 in major depressive disorder (MDD) did not meet its primary endpoint of reducing depressive symptoms.
Despite the primary endpoint not being met, BHV-7000 was safe and well-tolerated, and positive trends were observed in clinically relevant subgroups with more severe depression.
Due to strategic prioritization, Biohaven will not pursue additional psychiatric clinical trials for BHV-7000 in MDD, choosing to focus resources on immunology, obesity, and epilepsy in 2026.
The company plans to present these results at an upcoming scientific meeting and will provide broader clinical program updates at the J.P. Morgan Healthcare Conference in January 2026.

2 hours ago

Press Release

Biohaven Presents Positive Clinical Data for BHV-1510 at ESMO Immuno-Oncology Congress

BHVN

New Projects/Investments

Product Launch

Biohaven announced positive clinical safety and efficacy data for BHV-1510, a next-generation Trop2 ADC, in combination with cemiplimab at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress.
The combination therapy achieved a 72.7% confirmed objective response rate (ORR) in a pretreated population of advanced/metastatic cancer patients at the 2.5 mg/kg Q3W dose.
BHV-1510 demonstrated a favorable safety profile, with low rates of adverse events and no cases of interstitial lung disease, differentiating it from other Trop2 ADCs.

Dec 11, 2025, 12:00 PM

Press Release

Biohaven Ltd. Completes Public Offering of Common Shares

BHVN

Biohaven Ltd. entered into an underwriting agreement on November 12, 2025, for a registered public offering of its common shares.
On November 13, 2025, the company issued and sold 26,833,334 common shares at a public offering price of $7.50 per common share.
This issuance included the full exercise of the underwriters' option to purchase additional common shares.
The aggregate gross proceeds to Biohaven Ltd. from the offering were approximately $200 million.

Nov 13, 2025, 9:27 PM

8-K

Biohaven Closes Upsized Public Offering

BHVN

Biohaven Ltd. announced the closing of its underwritten public offering on November 13, 2025, which included the full exercise of the underwriters' option to purchase additional shares.
The offering comprised 26,833,334 common shares at a public offering price of $7.50 per share.
The offering was upsized to $175 million from the previously announced $150 million, generating approximately $200 million in gross proceeds before deducting underwriting discounts and commissions and offering expenses.
Biohaven intends to use the net proceeds received from the offering for general corporate purposes.

Nov 13, 2025, 9:05 PM

Press Release

Biohaven Announces Pricing of Public Offering

BHVN

Biohaven Ltd. (NYSE: BHVN) announced the pricing of an underwritten public offering of 23,333,334 common shares at $7.50 per share.
The offering is expected to generate approximately $175 million in gross proceeds before deducting underwriting discounts and commissions and offering expenses.
The underwriters have been granted a 30-day option to purchase up to an additional 3,500,000 common shares.
The offering is anticipated to close on November 13, 2025, with net proceeds intended for general corporate purposes.

Nov 12, 2025, 12:15 PM

Press Release

Biohaven Announces Proposed Public Offering of Common Shares

BHVN

Biohaven Ltd. has commenced an underwritten public offering of $150 million of its common shares.
The company expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of common shares.
The net proceeds from the offering are intended for general corporate purposes.
J.P. Morgan and Goldman Sachs & Co. LLC are acting as the book-running managers for the offering.

Nov 11, 2025, 9:05 PM

Press Release

Biohaven Reports Third Quarter 2025 Financial Results and Strategic Cost Optimization

BHVN

Earnings

Guidance Update

Biohaven Ltd. reported a net loss of $173.4 million, or $1.64 per share, for the third quarter ended September 30, 2025. The non-GAAP adjusted net loss for the same period was $155.9 million, or $1.47 per share.
The company initiated strategic cost optimization efforts, which are expected to achieve an approximately 60% reduction in annual direct R&D spend (excluding personnel and share-based compensation).
Key upcoming milestones include delivering top-line results from a Phase 2 study for opakalim in major depressive disorder in 4Q 2025 and initiating a Phase 2 clinical trial for taldefgrobep alfa in obesity in 4Q 2025.
As of September 30, 2025, Biohaven's cash, cash equivalents, marketable securities, and restricted cash totaled approximately $263.8 million.

Nov 10, 2025, 12:02 PM

8-K

Biohaven Reports Third Quarter 2025 Financial Results

BHVN

Earnings

Guidance Update

New Projects/Investments

Biohaven reported a GAAP net loss of $173.4 million, or $1.64 per share, for the third quarter ended September 30, 2025. The non-GAAP adjusted net loss for the same period was $155.9 million, or $1.47 per share.
As of September 30, 2025, Biohaven's cash, cash equivalents, marketable securities, and restricted cash totaled approximately $263.8 million.
The company initiated strategic cost optimization efforts, which are expected to achieve an approximate 60% reduction in annual direct R&D spend.
Biohaven continues to advance its late-stage clinical programs, including opakalim, BHV-1300, BHV-1400, and taldefgrobep alfa, with anticipated milestones such as top-line results from a Phase 2 study in major depressive disorder in 4Q 2025.

Nov 10, 2025, 11:58 AM

Press Release

Biohaven Faces FDA Rejection for Ataxia Drug and Announces R&D Spending Cuts

BHVN

New Projects/Investments

Guidance Update

Biohaven Ltd. received an FDA rejection for its drug Vyglxia (troriluzole) for spinocerebellar ataxia due to concerns about study design, potential bias, and the reliability of real-world evidence.
Following the rejection, Biohaven announced a strategic shift, including a 60% cut in its annual research and development spending, to focus on late-stage clinical programs and preserve cash.
Before the cuts, Biohaven spent $315 million on research and development during the first half of 2024.
The FDA decision caused Biohaven's stock to plummet to a 52-week low, leading analysts to downgrade the company's rating.

Nov 5, 2025, 5:58 PM

Morningstar

Biohaven Receives FDA Complete Response Letter for VYGLXIA NDA

BHVN

Guidance Update

New Projects/Investments

Biohaven Ltd. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on November 4, 2025, for its New Drug Application (NDA) seeking approval of VYGLXIA (troriluzole) for the treatment of spinocerebellar ataxia (SCA).
The FDA cited issues inherent to real-world evidence and external control studies, including potential bias, design flaws, lack of pre-specification, and unmeasured confounding factors, despite the study achieving statistical significance.
Following the CRL, Biohaven is initiating strategic portfolio and cost-optimization measures, which will result in an approximately 60% reduction in annual direct R&D spend (excluding personnel and SBC).
The company will prioritize three key late-stage clinical programs: clinical-stage lead extracellular degraders for IgA nephropathy (BHV-1400) and Graves' disease (BHV-1300); Opakalim, a Kv7 ion channel activator; and Taldefgrobep alfa, a myostatin-activin pathway inhibitor.