ACADIA Stock Drops After EU Rejects Rett Syndrome Drug

Key Developments in ACADIA's Drug Approval

ACADIA Pharmaceuticals stock (NASDAQ:ACAD) declined by 4.4% in after-hours trading following a negative preliminary opinion from the European Medicines Agency's CHMP regarding its Rett syndrome treatment, trofinetide.

Situation Overview

The Committee for Medicinal Products for Human Use (CHMP) issued an unfavorable trend vote on the Marketing Authorization Application for trofinetide. This drug is intended to treat Rett syndrome, a rare genetic neurological disorder. Despite the setback in the EU, trofinetide has already secured regulatory approval in the United States, Canada, and Israel, with over 1,000 patients currently receiving the treatment globally.

Market Impact and Outlook

The negative vote immediately impacted ACADIA's stock value. The company has announced its intention to request a re-examination of the CHMP's opinion, a process it can initiate within 15 days of the formal vote. ACADIA's management expressed disappointment but remains committed to making the treatment available to patients in the European Union.

Summary

The future of trofinetide in the European market now hinges on the re-examination process. While the CHMP's opinion is a significant hurdle, ACADIA's proactive stance and the drug's success in other major markets will be key factors for investors to watch in the coming months.

FAQ

Q: Why did ACADIA Pharmaceuticals' stock fall?
A: The stock dropped 4.4% after a European regulatory committee issued a negative preliminary opinion on its Rett syndrome drug, trofinetide.

Q: Is trofinetide approved anywhere else?
A: Yes, the drug is approved for use in the United States, Canada, and Israel.

Source: Investing.com