Acadia Pharmaceuticals Provides Update on Regulatory Submission for Trofinetide for the Treatment of Rett Syndrome in the European Union
ACADIA Pharmaceuticals Inc. (ACAD)
Last acadia pharmaceuticals inc. earnings: 2/26 04:05 pm
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Source: Business Wire
- Company expects to receive a negative opinion following oral explanation feedback and intends to request re-examination upon review of formal adoption. SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Company was informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on its Marketing Authorization Application (MAA) for trofinetide for the treatment of Rett syndrome, following its recent CHMP oral explanation. Subject to the outcome of the CHMP vote in February, Acadia intends to request a re-examination of the opinion by the CHMP upon its formal adoption.“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 Ad
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News
- Acadia Pharmaceuticals Provides Update on Regulatory Submission for Trofinetide for the Treatment of Rett Syndrome in the European Union [Yahoo! Finance]Yahoo! Finance
- ACADIA Pharmaceuticals Targets $1.7B Sales by 2028, Maps Key Remlifansirin Readouts at JPM Conf [Yahoo! Finance]Yahoo! Finance
- Acadia Pharmaceuticals Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- Acadia Pharmaceuticals Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare ConferenceBusiness Wire
- ACADIA Pharmaceuticals (NASDAQ:ACAD) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=ACAD&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StMarketBeat
ACAD
Earnings
- 11/5/25 - Beat
ACAD
Sec Filings
- 1/13/26 - Form 8-K
- 11/19/25 - Form 4
- 11/19/25 - Form 4
- ACAD's page on the SEC website