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What will be the outcome of Biohaven's FDA submission for troriluzole by end of 2024?
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Story
Biohaven Achieves Positive Results in Pivotal Study of Troriluzole for SCA, Stock Surges as FDA Approval Sought
Sep 23, 2024, 12:28 PM
Biohaven Pharmaceutical Holding Company Ltd. (BHVN) has achieved positive topline results in a pivotal study of troriluzole for the treatment of Spinocerebellar Ataxia (SCA), an ultra-rare genetic disease that affects the nervous system. The drug demonstrated statistically significant superiority on nine consecutive, prespecified primary and secondary endpoints. Patients treated with troriluzole showed a 50-70% slowing of disease progression, equating to a 1.5-2.2 years delay over a three-year period. This progress has led to a 16.4% pre-market increase in Biohaven's stock price. The company plans to seek FDA approval for troriluzole after a previous setback last year when the FDA refused to review the asset. The trial data has allayed investor concerns, sending shares up more than 12% during trading.
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