Watch for detailed Phase 2 data at CTAD in November and enrollment updates for the ongoing Phase 3 program. The primary endpoint miss (p=0.0603) introduces binary risk for Phase 3 success, but the nominal secondary endpoint win and clean safety profile support continued development in a large unmet-need market with no approved therapies.
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Executive Summary
Acadia Pharmaceuticals announced Phase 3-enabling topline results from the Phase 2 portion of the RADIANT trial evaluating remlifanserin for Alzheimer's disease psychosis. The 60 mg dose narrowly missed the primary endpoint (SAPS-H+D, p=0.0603) but hit the key secondary endpoint (CGI-S-ADP, p=0.0077 nominal) with a favorable safety profile. The company is proceeding with Phase 3 development, removing the 30 mg arm, and will present detailed data at CTAD in November.
Key Facts
- Primary endpoint SAPS-H+D: 60 mg remlifanserin -12.6 vs placebo -10.4 at week 6, effect size 0.26 (p=0.0603)
- Key secondary endpoint CGI-S-ADP: 60 mg -1.3 vs placebo -0.9, effect size 0.37 (p=0.0077 nominal)
- Favorable safety profile: adverse events, serious AEs, and discontinuations similar to placebo; no QT prolongation, no motor/cognition impact, no deaths in treatment arms
- Company plans to continue two ongoing Phase 3 studies, removing the 30 mg dosage arm
- Detailed results to be presented at CTAD conference November 16-19, 2026 in Boston
- Remlifanserin also in Phase 2 for Lewy body dementia psychosis
Financial Impact
No financial figures provided in the filing; the event is a clinical data readout with no revenue or cost disclosures
Risk Factors
- Primary endpoint did not reach statistical significance (p=0.0603), raising Phase 3 replication risk
- 30 mg dose showed minimal efficacy, limiting dose flexibility
- Phase 3 program still enrolling; results are years away and may not replicate Phase 2 trends
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-401157 |
| Document: d168737dex991.htm | 0001193125-26-401157 |
| Document: 0001193125-26-401157-index-headers.html | 0001193125-26-401157 |
| Document: 0001193125-26-401157-index.html | 0001193125-26-401157 |
| Document: 0001193125-26-401157.txt | 0001193125-26-401157 |
Filters
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Oct 23, 2026 3d ago | 8-K | $19.73 | awaiting T+20 | — | $19.85 (+0.61%) |
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May 6, 2026 24w ago | 8-K | $22.56 $21.43 | ▲ +5.01% | ▲ +8.14% | $19.85 (+12.01%) |
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Mar 5, 2026 33w ago | 8-K | $22.40 $22.20 | ▼ −0.89% | ▲ +2.90% | $19.85 (−11.38%) |
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