FDA approval of Daybue: first Rett syndrome drug
The FDA approved ACADIA’s Daybue (trofinetide) for Rett syndrome on Mar 10, 2023. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- ACADIA Pharmaceuticals Inc. ACAD
- Drug
- Daybue (trofinetide)
- For
- Rett syndrome
- When
- Mar 10, 2023
- Checked
- Checked by a person when it was added
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- ACAD headlines on this site
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.
More details
- Entry
- Remlifanserin Ph2 RADIANT ADP topline narrowed to Sept–Oct 2026 · Clinical trial results (readout / topline data)
- Drug
- Remlifanserin (ACP-204)
- For
- Hallucinations and delusions associated with Alzheimer's disease psychosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Existing item is dated 2026-H2; Acadia's Q2 2026 earnings release (Aug 4, 2026) narrows the window to September–October 2026. Date left at H2 because the company's window straddles Q3/Q4. Fast Track granted July 2026; Phase 3 screening/enrollment already started.
- Checked
- Checked by a person when it was added
- Verify it
- Source: acadia.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- ACAD headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- Entry
- European Commission decision on trofinetide (DAYBUE) in Rett syndrome · Regulatory approval
- Drug
- DAYBUE (trofinetide)
- For
- Rett syndrome (adults and children 5 years and older) — EU
- Stage
- CHMP positive opinion adopted; EC decision pending
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Acadia's Q2 2026 earnings release states CHMP adopted a positive opinion recommending EU marketing authorization; the European Commission decision typically follows within about two months (timing inferred, not company-stated).
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- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- ACAD headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- Entry
- Trofinetide Japan Ph3 Rett syndrome topline (Oct 2026–Mar 2027 window) · Clinical trial results (readout / topline data)
- Drug
- trofinetide (DAYBUE)
- For
- Rett syndrome (Japan)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Guidance from Acadia's JPM 2026 update (Jan 13, 2026); not re-stated in the Q2 2026 release. Company window runs October 2026 through March 2027, so the date field is set to 2026-H2 only as the earliest half of that window.
- Checked
- Checked by a person when it was added
- Verify it
- Source: acadia.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- ACAD headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page