Biohaven reported its recent business developments and financial results for the fourth quarter and full year 2024. The company announced that the FDA has accepted its New Drug Application (NDA) for troriluzole in spinocerebellar ataxia with Priority Review, with a decision expected in the third quarter of 2025. It also highlighted positive data from its BHV-1300 degrader program, showing up to 84% reduction in total IgG, with Phase 1 completion expected in the first half of 2025 and a planned Phase 2 study in Graves’ disease in mid-2025.
The company is advancing clinical programs across immunology, neuroscience, and oncology, including treatments for epilepsy, depression, OCD, migraine, pain, Alzheimer's, Parkinson's, multiple sclerosis, rheumatoid arthritis, and cancer. It is also developing therapies for rare diseases such as myasthenia gravis and spinal muscular atrophy. Biohaven continues progress on its selective TRAP degraders, with Phase 1 studies for BHV-1400 in IgA nephropathy and BHV-1600 in peripartum cardiomyopathy expected to conclude in the first half of 2025.
Among key upcoming milestones, Biohaven plans to launch troriluzole for spinocerebellar ataxia in 2025, pending FDA approval, and expects topline Phase 3 OCD trial data in the first half of 2025. The Kv7 activator BHV-7000 is undergoing registrational studies for epilepsy and depression, with results expected in 2025 and 2026. The company is also developing next-generation antibody-drug conjugates for cancer treatment, with interim Phase 1 data from BHV-1510 anticipated in late 2025 and the initiation of a Phase 1 trial for BHV-1530 in early 2025.
Financially, Biohaven ended 2024 with approximately $489 million in cash and securities. Research and development expenses for the year totaled $795.9 million, reflecting investments in late-stage trials and preclinical programs. The company reported a net loss of $846.4 million for 2024, compared to $408.2 million in 2023. Looking ahead, Biohaven remains focused on executing its clinical programs, advancing its innovative therapies, and achieving key regulatory and developmental milestones.