Remlifanserin (ACP-204) - (RADIANT)

January 13, 2026: Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) provided pipeline, regulatory and launch updates at the 44th Annual J.P. Morgan Healthcare Conference. Key upcoming catalyst: top-line results from the Phase 2 RADIANT study of remlifanserin (formerly ACP‑204) in Alzheimer’s disease psychosis are expected between August and October 2026; the company also cited remlifanserin’s potential in Alzheimer’s disease psychosis and Lewy body dementia psychosis.

DAYBUE STIX (trofinetide) for oral solution (powder; dye- and preservative-free) was approved by the U.S. FDA on December 12, 2025 for Rett syndrome in adults and pediatric patients ≥2 years. A limited U.S. launch is planned to begin in Q1 2026, with a full launch in Q2 2026. International/regulatory catalysts for trofinetide include: Israel Ministry of Health approval of DAYBUE oral solution for Rett syndrome (≥2 years, ≥9 kg), an EMA CHMP opinion expected in Q1 2026, and top-line results from a Phase 3 Japan study anticipated between October 2026 and March 2027.

The company reiterated a 2028 net sales projection of $1.7B combined for NUPLAZID ($1B) and DAYBUE (~$700M), and plans to initiate five Phase 2/3 studies and deliver four Phase 2/3 readouts by end of 2027 across eight programs.