Biohaven Says FDA Informed Co. It Would Not Review NDA For Troriluzole Because Primary Endpoint Was Not Met
Portfolio Pulse from Bill Haddad
The FDA has informed Biohaven that it will not review the NDA application for troriluzole as the study's primary endpoint was not met. Biohaven may request a Type A meeting within 30 days to address FDA's concerns. Updates regarding the meeting will be provided after the upcoming regulatory interaction.
July 27, 2023 | 11:09 am
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Biohaven's NDA for troriluzole was not reviewed by the FDA due to unmet primary endpoint. The company may request a meeting to address FDA's concerns.
The FDA's refusal to review the NDA for troriluzole is a setback for Biohaven, potentially delaying the drug's approval and launch. This could negatively impact the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100