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ACADIA Pharmaceuticals Reports Second Quarter 2020 Financial Results
- 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19 - FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n- 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19 \n\n\n- FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related psychosis with a PDUFA action date set for April 3, 2021\n\n\n- Initiated ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia\n\n SAN DIEGO--(BUSINESS WIRE)--\nACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020.\n\n\n“In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis we are one step closer to potentially delivering the first and only approved treatment for this devastating condition,” said Steve Davis, ACADIA’s Chief Executive Officer. “Building upon the successful development of our PDP and DRP programs, our clinical team is focused on advancing our innovative early- and late-stage pipeline.”\n\n\nCompany Updates\n\n\n\nThe U.S. Food and Drug Administration (FDA) filed the supplemental NDA for pimavanserin for the treatment of the hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021.\n\n\nACADIA announced top-line results from the Phase 3 CLARITY study of pimavanserin for adjunctive treatment in patients with major depressive disorder. The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.\n\n\nACADIA initiated its second pivotal study, ADVANCE-2, a 26-week, placebo-controlled, 386 patient Phase 3 study designed to evaluate the efficacy and safety of the 34 mg dose of pimavanserin for the treatment of the negative symptoms of schizophrenia.\n\n\nACADIA presented important clinical data at recent virtual medical congresses:\n\n\nIn May, at the 2020 American Society of Clinical Psychopharmacology virtual annual meeting, ACADIA presented six posters and an oral presentation on the positive pivotal ADVANCE study results, titled ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study ...