Biohaven Ltd.

Biohaven Ltd. announced that the FDA has accepted its new drug application resubmission for Vyglxia (troriluzole) for the treatment of spinocerebeller ataxia (SCA). The FDA considers this resubmission a complete response to a previous action letter, with a user fee goal date set for Q1 2027. An advisory committee meeting is anticipated to gather external stakeholder input.

Biohaven Ltd. reported a net loss of $137.3 million, or $0.91 per share, for the second quarter ended June 30, 2026. Non-GAAP adjusted net loss was $118.1 million, or $0.78 per share. The company significantly advanced its pipeline, initiating a pivotal Phase 3 study for BHV-1300 in Graves' disease and expecting key data readouts for opakalim and taldefgrobep alfa in the second half of 2026. R&D and G&A expenses decreased compared to the prior year, and the company maintained a cash position of $270.5 million.

Biohaven Ltd. announced the appointment of John Yetimoglu to its Board of Directors, effective August 6, 2026. Mr. Yetimoglu will also join the Nominating and Governance Committee. As part of his compensation, he will receive options valued at $713,875 and an annual retainer of $57,000.

Biohaven Ltd. announced scientific leadership transitions, effective July 13, 2026. Dr. Bruce Car will transition from Chief Scientific Officer to a new part-time role as Chief Innovation Officer, focusing on external collaborations and the Bexorg partnership, with a 50% salary reduction. Concurrently, Dr. David Pirman has been promoted to Executive Vice President and Head of Discovery, leading the company's internal drug-discovery organization. Warren Volles, General Counsel, was also designated an executive officer.

Biohaven Ltd. announced positive new clinical data for its selective Kv7.2/7.3 activator, opakalim, in epilepsy, demonstrating a 3-fold prolongation in time to second generalized tonic-clonic seizure in IGE and a 54% seizure frequency reduction in focal epilepsy with a favorable tolerability profile. Additionally, the company reported compelling positive clinical biomarker and patient data for its extracellular protein degraders, BHV-1300 for Graves' disease and BHV-1400 for IgA nephropathy, showing deep and rapid lowering of disease-driving antibodies. Pivotal Phase 3 trials for both autoimmune programs are set to begin by mid-2026.

Biohaven Ltd. has amended its Equity Distribution Agreement, allowing the company to sell up to an aggregate offering price of $350.0 million of its common shares through an "at-the-market" equity offering program. J.P. Morgan Securities LLC will serve as the manager for these sales, which may occur on the New York Stock Exchange or through negotiated transactions. The actual sales will depend on market conditions, the trading price of common shares, and the company's capital needs.

Biohaven Ltd. reported a reduced net loss for Q1 2026, decreasing to $(130.5) million from $(221.7) million in Q1 2025, driven by a significant reduction in operating expenses, particularly R&D. The company's cash and cash equivalents increased to $273.1 million, and total shareholders' equity rose to $129.5 million, largely due to $178.9 million in proceeds from common share issuance. Biohaven continues to fund operations through equity and debt, including senior secured notes, and expects current liquidity to last at least one year.

Biohaven Ltd. reported a net loss of $130.5 million, or $0.88 per share, for the first quarter ended March 31, 2026, a significant reduction from $221.7 million, or $2.17 per share, in the prior year period. The company also highlighted substantial progress in its clinical pipeline, including the expected mid-year initiation of pivotal trials for BHV-1400 in IgA nephropathy and BHV-1300 in Graves' disease. Additionally, topline results for its pivotal epilepsy program and Phase 2 obesity study are anticipated in the second half of 2026.