Announced today that the marketing authorization application for DAYBUE™ has been submitted to the European Medicines Agency (EMA) with expected approval in the first quarter of 2026.
Initiation of Managed Access Programs in Europe in the second quarter of 2025, potentially resulting in the Company’s first revenues from outside the U.S.
Enrollment of the last patient in the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi Syndrome anticipated in the fourth quarter of 2025, followed by top-line results announcement in the first half of 2026.
Enrollment of the last patient in the RADIANT Phase 2 study of ACP-204 in Alzheimer’s disease psychosis expected in the first quarter of 2026, followed by top-line results announcement in mid-2026.
Initiation of a Phase 2 study of ACP-204 for a second indication in Lewy Body Dementia in the third quarter of 2025.
The Company will host its first ever R&D Day in mid-2025.
Annual net sales for the full-year 2025 expected to exceed $1 billion for the first time in Company history.
Today’s presentation will take place at 9:00 a.m. Pacific Time / 12:00 p.m. Eastern Time. A live webcast of the presentation will be accessible on the Company’s website, Acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following the presentation.
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