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ACAD Stock Soars as US Court Rules in Favor of Key Nuplazid Patent
ZACKS· 2025-05-19 14:36
Core Viewpoint - Acadia Pharmaceuticals' shares increased by 26.5% following a favorable ruling from the U.S. District Court regarding the patent for its lead drug, Nuplazid, which protects the company from generic competition until 2038 [1][3]. Company Performance - Nuplazid is the only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis in the U.S. [2] - In Q1 2025, Nuplazid generated $159.7 million in revenue, marking a 23% year-over-year increase driven by volume growth [3]. - Year-to-date, Acadia's shares have risen by 21.3%, contrasting with a 6.9% decline in the industry [4]. Product Portfolio - Acadia's other marketed drug, Daybue, approved for treating Rett syndrome, generated $84.6 million in revenue in Q1 2025, an 11% increase year-over-year [5]. - Daybue reached a record high of 954 unique patients receiving shipments in Q1 2025 [7]. Pipeline Developments - Acadia is awaiting EU regulatory approval for trofinetide to treat Rett syndrome, expected in Q1 2026 [8]. - The company anticipates top-line results from the phase III COMPASS PWS study of ACP-101 for Prader-Willi Syndrome in early Q4 2025, with plans to submit a regulatory application to the FDA in Q1 2026 [9]. - Enrollment for the phase II RADIANT study of ACP-204 for Alzheimer's disease psychosis is expected to be completed in Q1 2026, with top-line data anticipated in mid-2026 [10]. - Acadia and Saniona have completed the phase I study of ACP-711, which showed a strong safety profile, and are focusing on essential tremor as the lead indication [11][12].
Appili Therapeutics Announces New Patents Granted for Commercial Stage Asset LIKMEZ®™
Globenewswire· 2025-04-28 11:41
Core Viewpoint - Appili Therapeutics has secured new patents for its oral formulation of metronidazole, LIKMEZ, enhancing its market protection and supporting its commercialization efforts [1][2][3] Patent Protection - The newly granted patents will expire in 2039 and provide comprehensive protection for LIKMEZ, covering its unique taste-masked composition and therapeutic applications [2] - The U.S. patent has been listed in the FDA's Orange Book, which is crucial for ensuring additional protection for the formulation [2][3] Product Overview - LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, specifically designed for treating antimicrobial-resistant infections, particularly beneficial for patients with dysphagia [4] - The formulation aims to improve stability and palatability, which are essential for patient adherence to medication and better treatment outcomes [3] Commercialization Efforts - Saptalis Pharmaceuticals, the partner of Appili, is planning to re-launch LIKMEZ under its own label in May 2025, leveraging the newly granted patent for commercialization activities [3][4] - The collaboration with Saptalis emphasizes the commitment to bringing innovative pharmaceutical solutions to market [5][6] Company Background - Appili Therapeutics focuses on developing therapies for infectious diseases and aims to address urgent medical needs through a diverse pipeline of anti-infectives [7][9] - The company is strategically positioned to tackle life-threatening infections, with a proven management team leading its initiatives [9]