Biohaven’s troriluzole rejected before FDA review
Biohaven said Thursday it received a refusal-to-file letter from the FDA over its NDA for troriluzole in an announcement that sent its share price down more than 26% in market trading.
The regulator reportedly told the company it would not review the drug because the primary endpoint in the study it submitted was not met. Biohaven said in May 2022 that troriluzole missed the primary endpoint in a Phase III last year that enrolled 213 patients with different types of spinocerebellar ataxia (SCA).
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