Acadia Pharmaceuticals Announces Plan to Request Re-Examination Following Negative CHMP Opinion for Trofinetide for the Treatment of Rett Syndrome
ACADIA Pharmaceuticals Inc. (ACAD)
Last acadia pharmaceuticals inc. earnings: 2/26 04:05 pm
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Source: Business Wire
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) informed the company it has formally adopted a negative opinion regarding the Marketing Authorization Application for trofinetide for the treatment of Rett syndrome in patients two years of age and older. Acadia has reviewed the CHMP grounds for refusal in detail and intends to request a re-examination of the opinion.While the pivotal LAVENDERTM trial successfully met its co-primary and key secondary endpoints, the CHMP issued a refusal based on perceived deficits including: the treatment effect observed with trofinetide after 12 weeks, while measurable, was viewed as limited in magnitude; the study did not capture all core symptoms of Rett syndrome; and that assessment of longer-term outcomes was influenced by patient discontinuations over time. Acadia believes this feedback provides important
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ACAD
News
- Wolfe Research Notes Conviction-Driven Opportunities in ACADIA Pharmaceuticals Inc.'s (ACAD) Therapeutic Domains [Yahoo! Finance]Yahoo! Finance
- Acadia Pharmaceuticals: Undervalued Despite Robust Revenues From Approved Drugs, With Pipeline Kicker [Seeking Alpha]Seeking Alpha
- ACADIA Pharmaceuticals (ACAD) had its price target raised by TD Cowen from $35.00 to $37.00. They now have a "buy" rating on the stock.MarketBeat
- ACADIA Pharmaceuticals (ACAD) had its price target lowered by Royal Bank Of Canada from $31.00 to $30.00. They now have an "outperform" rating on the stock.MarketBeat
- ACADIA Pharmaceuticals (ACAD) had its price target raised by Citizens Jmp from $34.00 to $35.00. They now have a "market outperform" rating on the stock.MarketBeat
ACAD
Earnings
- 2/25/26 - Beat
ACAD
Sec Filings
- 2/26/26 - Form SCHEDULE
- 2/26/26 - Form 10-K
- 2/25/26 - Form 8-K
- ACAD's page on the SEC website