secwatch.observer — SEC 8-K summary
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Issuer:     ACADIA PHARMACEUTICALS INC (ACAD)
CIK:        0001070494
Form:       8-K
Filed at:   2021-12-06T23:59:59+00:00
Accession:  0001193125-21-349137
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Acadia reports positive Phase 3 trofinetide results in Rett syndrome; NDA plan mid-2022
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- Trofinetide met co-primary endpoints: RSBQ change -5.1 vs -1.7 (p=0.0175); CGI-I 3.5 vs 3.8 (p=0.003).
- Key secondary endpoint CSBS-DP-IT-Social also met: -0.1 vs -1.1 (p=0.0064); effect size 0.43.
- Discontinuation due to AEs 17.2% trofinetide vs 2.1% placebo; diarrhea (80.6%) and vomiting (26.9%) most common.
- Pre-NDA meeting with FDA planned Q1 2022; NDA submission expected mid-2022; Fast Track, Orphan, RPD designations granted.
- More than 95% of completers rolled into open-label Lilac extension; Acadia licensed trofinetide from Neuren Pharmaceuticals.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1070494/000119312521349137/0001193125-21-349137-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1070494/000119312521349137/d257158d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-349137

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