Acadia raises 2026 revenue guidance on DAYBUE and NUPLAZID growth
The company also completed Phase 2 enrollment in its remlifanserin Alzheimer's psychosis program and won FDA Fast Track designation, with topline data expected in September to October 2026.
Acadia Pharmaceuticals reported second quarter 2026 results on August 4, 2026 and updated its pipeline timeline for remlifanserin, an investigational treatment for Alzheimer's disease psychosis. The company said it completed enrollment in the Phase 2 portion of the RADIANT program evaluating remlifanserin in Alzheimer's disease psychosis and began Phase 3 screening and enrollment, with topline Phase 2 results expected in September to October 2026.1
The FDA granted the drug a Fast Track designation, a status the agency assigns to remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis, in recognition of its potential to address a significant unmet medical need.1
In Europe, the CHMP of the EMA issued a positive opinion for DAYBU (trofinetide), recommending marketing authorization for treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older; if the European Commission approves it, DAYBU would be the first authorized Rett syndrome treatment in the EU.1
On guidance, Acadia said it is revising full year 2026 total revenue guidance to a range of $1.24 to $1.30 billion, higher than its prior range of $1.22 to $1.28 billion.1 Within that, DAYBUE global net product sales guidance was raised to $480 to $510 million from $460 to $490 million,1 while NUPLAZID net product sales guidance was reaffirmed at $760 to $790 million.1 The company also lowered its R&D expense outlook, now projecting $355 to $380 million, down from a prior range of $385 to $410 million.1
On the balance sheet, Acadia reported cash, cash equivalents, and investment securities totaling $956 million as of June 30, 2026, compared with $820 million at December 31, 2025.1
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