Acadia Pharma (ACAD) Reports Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome

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Go back to Acadia Pharma (ACAD) Reports Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome

Acadia Pharmaceuticals Announces Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome

December 6, 2021 4:05 PM EST

- Trofinetide met co-primary efficacy endpoints demonstrating statistically significant improvement over placebo in the Rett Syndrome Behaviour Questionnaire (RSBQ) (p=0.0175) and the Clinical Global Impression of Improvement (CGI-I) (p=0.0030)

- Trofinetide met key secondary endpoint demonstrating statistically significant improvement over placebo in CSBS-DP-ITSocial (p=0.0064), caregiver scale of ability to communicate

- Pre-New Drug Application meeting with the U.S. FDA planned for the first quarter 2022

- Conference call and webcast to be held today at 4:30 p.m. Eastern Time

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