Investing.com -- ACADIA Pharmaceuticals Inc (NASDAQ:ACAD) stock dropped 4.4% in after-hours trading Monday following news that European regulators issued a negative trend vote on the company’s Rett syndrome treatment.
The biopharmaceutical company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) delivered an unfavorable preliminary opinion on its Marketing Authorization Application for trofinetide. The drug is designed to treat Rett syndrome, a rare genetic neurological disorder.
ACADIA said it plans to request a re-examination of the opinion after the CHMP’s formal vote in February. The company has the right to request this re-examination within 15 calendar days of receiving the opinion, followed by submission of grounds for the request within 60 days.
"While the negative trend vote is disappointing and not what we hoped for, we believe the strong data that supported the approval of trofinetide for the treatment of Rett syndrome in the United States, Canada, and Israel speak to the meaningful benefits that trofinetide can deliver," said Catherine Owen Adams, Chief Executive Officer of ACADIA.
The company noted that more than 1,000 patients globally are currently receiving the treatment, ranging from newly diagnosed 2-year-olds to adults who have lived with the disease for decades. Trofinetide has already received regulatory approvals in several countries including the United States.
ACADIA emphasized its commitment to making the treatment available in the European Union, stating it will work with the EMA and other stakeholders to advance trofinetide as a potential treatment option for Rett syndrome patients in Europe.
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