ACADIA Pharmaceuticals experienced a 6.5% stock drop after the EMA’s CHMP issued a negative trend vote on its Marketing Authorization Application for DAYBUE in Rett syndrome, prompting the company to seek re-examination. This regulatory hurdle in Europe contrasts with the drug’s recent U.S. FDA approval for a new formulation, highlighting differing market challenges. Despite this setback, ACADIA’s broader investment narrative continues to focus on its CNS and rare-disease franchise growth, with future earnings and guidance being key catalysts.
This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.
ACADIA Pharmaceuticals (ACAD) Is Down 6.5% After CHMP Negative Trend Vote on Rett Drug DAYBUE
ACADIA Pharmaceuticals experienced a 6.5% stock drop after the EMA’s CHMP issued a negative trend vote on its Marketing Authorization Application for DAYBUE in Rett syndrome, prompting the company to seek re-examination. This regulatory hurdle in Europe contrasts with the drug’s recent U.S. FDA approval for a new formulation, highlighting differing market challenges. Despite this setback, ACADIA’s broader investment narrative continues to focus on its CNS and rare-disease franchise growth, with future earnings and guidance being key catalysts.