Clinical Data from Open-Label DAFFODIL™ Study Evaluating Long-term Safety of DAYBUE® (trofinetide) in Patients with Rett Syndrome Published in Med
ACADIA Pharmaceuticals Inc. (ACAD)
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Source: Business Wire
-- Study supported FDA and Health Canada approvals of DAYBUE for treatment of Rett syndrome in patients ages two years and older-- Results consistent with Phase 3 LAVENDER™ and open-label LILAC™ studies SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the journal Med published results from the open-label study, DAFFODIL™, evaluating the safety, tolerability and exploratory efficacy of DAYBUE® (trofinetide) in girls ages two to four living with Rett syndrome (n = 15). The long-term Phase 2/3 study demonstrated DAYBUE had a similar safety profile in children two to four years of age as that observed in individuals with Rett syndrome five years of age and older in the 12-week LAVENDER™ study, and the 40-week LILAC-1™ and 32-month LILAC-2™ open-label extension studies. Results of all four studies supported the FDA approval of DAYBUE in adults and pediatric patients two years of age or older.“Rett syndrome is a debilitating condition that often
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ACAD
Earnings
- 11/5/25 - Beat
ACAD
Sec Filings
- 11/19/25 - Form 4
- 11/19/25 - Form 4
- 11/14/25 - Form SCHEDULE
- ACAD's page on the SEC website