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(Reuters) -Biohaven's drug for a genetic disease that affects the nervous system met the main study goal, sending its shares up more than 15% as the trial data allayed investor worries following a setback last year.
The company said on Monday it would submit a marketing application to the U.S. Food and Drug Administration (FDA) based on the trial and was prepared for a potential launch in 2025.
In July 2023, the health regulator declined to review the company's marketing application based on a late-stage study of the drug, troriluzole, from 2022, as it had failed to meet the main goal.
Troriluzole is part of Biohaven's non-migraine drugs spun off into a new company in 2022, after Pfizer acquired the migraine assets in an $11.6 billion deal.
In the trial, the drug showed 50% to 70% slowing of disease progression in patients with Spinocerebellar Ataxia (SCA) after three years of treatment, the company said on Monday.
SCA is caused by the degeneration of cells in brain and spinal cord and can lead to uncoordinated movement and muscle wasting.
It affects about 15,000 people in the U.S., according to company estimates, and has no approved treatments in the country.
(Reporting by Christy Santhosh; Editing by Shailesh Kuber and Sriraj Kalluvila)
