Business
Acadia Pharmaceuticals Reports First Quarter 2023 Financial Results and Operating Overview
- 1Q23 NUPLAZID® net sales of $118.5 million - Announced the U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n- 1Q23 NUPLAZID® net sales of $118.5 million\n\n\n- Announced the U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older on March 10, 2023\n\n\n- Announced DAYBUE Availability on April 17, 2023\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the first quarter ended March 31, 2023.\n\n\n“We are excited with the recent approval and subsequent launch of DAYBUE, the first and only FDA-approved medicine for the treatment of Rett syndrome. We are executing on our launch strategy to bring this important new treatment to the Rett patient community, while remaining focused on delivering increasing profitability from our NUPLAZID franchise for Parkinson’s disease psychosis,” said Steve Davis, Chief Executive Officer. “In addition to our commercial business, we’ve made important strides in our pipeline including completion of the Phase 1 development program for ACP-204. And finally, we are nearing enrollment completion of the Phase 3 program for pimavanserin as a potential treatment for the negative symptoms of schizophrenia with top-line results expected in early 2024.”\n\n\nCompany Operational, Scientific, and Regulatory Updates\n\n\n\nOn March 10, 2023, DAYBUE™ (trofinetide) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.\n\n\n\n\nIn connection with the FDA approval of DAYBUE, Acadia received a Rare Pediatric Disease Priority Review Voucher.\n\n\n\n\nAnnounced DAYBUE availability on April 17, 2023.\n\n\n\n\nThe Company expects to complete enrollment in ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia, around mid-year with top-line results expected in early 2024.\n\n\n\n\nACP-204 has completed Phase 1 development. ACP-204 demonstrated a favorable safety and tolerability profile and we identified the doses we plan to evaluate in Phase 2. The Phase 1 data supports ACP-204’s target product profile as a potential treatment for Alzheimer’s disease psychosis. Acadia plans to meet with the FDA to discuss the clinical development plan.\n\n\n\nFinancial Results\n\n\nRevenue\n\n\nNet sales of NUPLAZID® were $118.5 million for t...