ACAD Acadia

remlifanserin · NCT06159673 registry update

countries: {'total_sites': 152, 'us_sites': 50} → {'total_sites': 154, 'us_sites': 52}

remlifanserin · NCT06159673 registry update

countries: {'total_sites': 151, 'us_sites': 49} → {'total_sites': 152, 'us_sites': 50}

remlifanserin · NCT06159673 registry update

countries: {'total_sites': 150, 'us_sites': 48} → {'total_sites': 151, 'us_sites': 49}

remlifanserin · NCT07029581 registry update

countries: {'total_sites': 60, 'us_sites': 29} → {'total_sites': 61, 'us_sites': 30}

Acadia Receives USPTO Notice of Allowance for Trofinetide Weight-Banded Dosing Patent

The USPTO issued a Notice of Allowance for U.S. Patent Application No. 17/590,496 covering weight-banded dosing of trofinetide for Rett syndrome. Upon issuance and with pediatric exclusivity, this extends U.S. patent protection from July 2036 to March 2041.

remlifanserin · NCT06159673 registry update

countries: {'total_sites': 149, 'us_sites': 47} → {'total_sites': 150, 'us_sites': 48}

Acadia remlifanserin Phase 2 RADIANT topline in Alzheimer's disease psychosis

Phase 2 RADIANT narrowly missed primary SAPS-H+D endpoint (p=0.0603) but showed nominal significance on key secondary CGI-S-ADP (p=0.0077) for 60 mg dose with consistent trends and favorable safety. Company will continue two ongoing Phase 3 studies in ADP after removing 30 mg arm and present detailed data at CTAD in November 2026.

Acadia: EC approves DAYBU (trofinetide) for Rett syndrome in EU

The European Commission granted marketing authorization for DAYBU (trofinetide) for neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only approved treatment for Rett syndrome in the EU. The approval is based on the Phase 3 LAVENDER study results showing statistically significant improvements in core Rett syndrome features. Acadia will now begin pricing and reimbursement negotiations with national authorities in the 27 EU member states plus Iceland, Liechtenstein, and Norway.

Acadia receives FDA Fast Track for remlifanserin in Alzheimer's psychosis

The document states Acadia received FDA Fast Track designation for remlifanserin in Alzheimer's disease psychosis. It also notes that Phase 2 topline results from the RADIANT program are expected September to October 2026, and that Phase 3 screening and enrollment have begun.

Acadia receives FDA Fast Track for remlifanserin in Alzheimer’s disease psychosis

FDA granted Fast Track designation to remlifanserin for Alzheimer’s disease psychosis, recognizing the unmet need. Phase 2 RADIANT enrollment is complete and topline results are now guided for September-October 2026. Phase 3 screening and enrollment have begun under the seamless design.

Acadia DAYBU (trofinetide) receives positive CHMP opinion for Rett syndrome

CHMP adopted a positive opinion recommending EU marketing authorization for DAYBU (trofinetide) in Rett syndrome. The European Commission decision is expected in the coming months. If approved, DAYBU would be the first approved therapy for neurobehavioral symptoms of Rett syndrome in the EU.