Acadia Pharmaceuticals today confirmed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is likely to issue a negative opinion on its trofinetide marketing application for Rett syndrome. The CHMP is scheduled to vote in late February 2026, and management now anticipates that a negative ruling will postpone any EU approval until the second half of 2026. Acadia had projected trofinetide EU launch revenues of €50 million in 2026 but is revising that estimate downward by roughly 20%. The setback will require the company to rely more heavily on its U.S. franchise, particularly NUPLAZID®, while preparing an additional clinical study to address CHMP concerns over long-term safety data.

Acadia has a notable track record of exceeding consensus earnings estimates, beating expectations in each of the past eight quarters. On average, the company’s quarterly adjusted EPS surpassed analyst forecasts by 15%, translating to a mean surprise of $0.05 per share. Operational leverage in its U.S. specialty neurology segment, combined with a 10% reduction in G&A expenses over the last year, has driven a pre-tax margin expansion of 250 basis points. As of December 31, 2025, Acadia held cash and marketable securities totaling $600 million, providing additional runway for continued R&D investment and potential M&A opportunities.

Analysts currently project Acadia’s fourth-quarter 2025 revenue at $120 million, up from $110 million in the year-ago period, reflecting a 9% year-over-year increase. Growth is expected to be fueled by sustained U.S. sales of NUPLAZID®—which accounted for 85% of total sales in prior quarters—and an accelerating uptake of trofinetide following its U.S. launch in September 2025, where prescription volume reached 3,000 scripts in the first month. R&D expenditures are forecast to remain near $60 million, while adjusted EBITDA margins are estimated at 30%, supporting a full-year outlook of positive free cash flow generation in excess of $100 million.