ACAD · Company research
3 upcoming catalysts · 0 phase 2+ trials on file
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ACADIA expects to report results from its Phase 3 study of Remlifanserin (ACP-204) for Hallucinations and delusions associated with Alzheimer's disease psychosis in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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ACADIA expects European regulators to decide on DAYBUE (trofinetide) for Rett syndrome (adults and children 5 years and older) — EU in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
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ACADIA expects to report results from its Phase 3 study of trofinetide (DAYBUE) for Rett syndrome (Japan) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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FDA grants Fast Track to remlifanserin for Alzheimer's disease psychosis, on Jul 20, 2026. A company milestone for ACADIA (remlifanserin (ACP-204) for Alzheimer's disease psychosis): a step in the program rather than a decision or a data readout.
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CHMP positive opinion recommends EU approval of DAYBU (trofinetide) in Rett, on Jun 26, 2026. A company milestone for ACADIA (trofinetide (DAYBU) for Rett syndrome): a step in the program rather than a decision or a data readout.
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CHMP adopts negative opinion on trofinetide for Rett syndrome; re-exam planned, on Mar 2, 2026. A company milestone for ACADIA (trofinetide (DAYBUE/DAYBU) for Rett syndrome): a step in the program rather than a decision or a data readout.
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The FDA approved ACADIA’s Daybue (trofinetide) for Rett syndrome on Mar 10, 2023. The company can now sell it in that market.
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