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SAN DIEGO - Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced plans to initiate seven Phase 2 or Phase 3 clinical studies during 2025-2026 and anticipates five late-stage study readouts through 2027, according to a company statement released ahead of its inaugural R&D Day on Wednesday.
The company’s pipeline includes nine disclosed programs targeting neurological and rare diseases. Key upcoming milestones include the initiation of a Phase 2 study for ACP-204 in Lewy Body Dementia Psychosis in Q3 2025 and topline results from the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi syndrome in early Q4 2025.
Additional planned initiatives include a Phase 3 study in Japan for trofinetide in Rett syndrome starting Q3 2025, a Phase 2 study for ACP-211 in major depressive disorder in Q4 2025, and first-in-human studies of ACP-271 in healthy volunteers by Q4 2025.
"As we advance our pipeline, the five molecules we showcase today represent a multibillion-dollar incremental revenue opportunity," said Catherine Owen Adams, Chief Executive Officer, in the press release.
The company’s commercial portfolio is expected to generate over $1 billion in net sales this year. Acadia is developing treatments for conditions including Alzheimer’s disease psychosis, major depressive disorder, essential tremor, and Huntington’s disease.
Acadia currently markets NUPLAZID for Parkinson’s disease psychosis and DAYBUE, which the company describes as the first and only approved drug in the United States and Canada for Rett syndrome.
The company stated it anticipates potential approval from the European Medicines Agency for trofinetide in Q1 2026 and topline results from the ACP-204 Phase 2 study in Alzheimer’s disease psychosis by mid-2026.
In other recent news, Acadia Pharmaceuticals reported a significant legal victory as the U.S. Court of Appeals for the Federal Circuit upheld the validity of the patent for its drug NUPLAZID, securing its protection through 2030. This decision safeguards Acadia’s intellectual property rights against MSN Laboratories and MSN Pharmaceuticals, ensuring the exclusivity of its flagship product in the market. Additionally, RBC Capital raised its price target for Acadia Pharmaceuticals to $38 from $26, maintaining an Outperform rating and highlighting the company’s solid commercial position and emerging pipeline. The firm noted that Acadia’s recent Nuplazid intellectual property win contributes to cash flow sustainability. Meanwhile, Cantor Fitzgerald reiterated its Overweight rating on Acadia, emphasizing the growth potential of the Daybue medication, supported by a 30% expansion in the field force. In related news, Macquarie initiated coverage on Neuren Pharmaceuticals with an Outperform rating, citing its partnership with Acadia as a key advantage. This collaboration covers all commercialization costs for DAYBUE, with Neuren receiving royalties and milestone payments. These developments reflect ongoing strategic maneuvers and legal successes for Acadia Pharmaceuticals.
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