ACP-204 / Acadia Pharma - LARVOL DELTA

Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "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."

New P2 trial • Sales projection • Dementia

Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "Key 2025-2026 Milestones...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."

Commercial • Enrollment status • P2 data • P3 data: top line • Alzheimer's Disease • CNS Disorders • Prader–Willi syndrome

ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study (clinicaltrials.gov) - P3 | N=752 | Enrolling by invitation | Sponsor: ACADIA Pharmaceuticals Inc. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Alzheimer's Disease • CNS Disorders • Psychiatry

ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study (clinicaltrials.gov) - P3 | N=752 | Not yet recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

New P3 trial • Alzheimer's Disease • CNS Disorders • Psychiatry

ACP-204 in Adults With Alzheimer's Disease Psychosis (clinicaltrials.gov) - P2/3 | N=1074 | Recruiting | Sponsor: ACADIA Pharmaceuticals Inc.

New P2/3 trial • Alzheimer's Disease • CNS Disorders • Psychiatry

Acadia Pharmaceuticals Initiates Phase 2 Clinical Trial of ACP-204 for the Treatment of Alzheimer’s Disease Psychosis (Businesswire) - "Acadia Pharmaceuticals Inc...today announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP)....The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes three studies: a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo. The primary endpoint is change from Baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales (SAPS-H+D) total score at Week 6."

New P2a trial • Alzheimer's Disease • CNS Disorders • Psychiatry