{"schema":"rootz.ai/sec-company/v1","layer":1,"cik":"0001802665","name":"Harmony Biosciences Holdings, Inc.","summary":"Harmony Biosciences Holdings, Inc. is a neuroscience company focused on rare neurological diseases. Its lead commercial product, WAKIX (pitolisant), is an FDA-approved, first-in-class H3 receptor antagonist/inverse agonist for narcolepsy in adults and pediatric patients. The company also has pipeline assets including next-generation pitolisant formulations, EPX-100 and EPX-200 for rare epilepsy, an orexin 2 receptor agonist (BP1.15205), and two discovery-stage cell replacement therapy candidates for narcolepsy and epilepsy.","people":[],"products":[{"name":"WAKIX (pitolisant)","type":"platform","description":"FDA-approved H3 receptor antagonist/inverse agonist for EDS and cataplexy in adult and pediatric narcolepsy patients; non-scheduled, once-daily oral tablet."},{"name":"Pitolisant Gastro-Resistant (Pitolisant GR)","type":"platform","description":"Next-generation pitolisant formulation in clinical development under the 2022 LCA with Bioprojet."},{"name":"Pitolisant High-Dose (Pitolisant HD)","type":"platform","description":"Next-generation pitolisant formulation in clinical development; being pursued for idiopathic hypersomnia."},{"name":"EPX-100","type":"platform","description":"Serotonin 5HT-2 receptor agonist in two Phase 3 trials for Dravet Syndrome and Lennox-Gastaut Syndrome."},{"name":"EPX-200","type":"platform","description":"Selective 5HT-2C agonist in pre-IND phase for developmental and epileptic encephalopathies."},{"name":"BP1.15205","type":"platform","description":"Orexin 2 receptor agonist in preclinical development for narcolepsy and other indications, sublicensed from Bioprojet."},{"name":"CBS105","type":"platform","description":"Discovery-stage cell replacement therapy candidate for treatment-resistant narcolepsy, developed with CiRC Biosciences."},{"name":"CBS104","type":"platform","description":"Discovery-stage cell replacement therapy candidate for refractory epilepsy, developed with CiRC Biosciences."}],"partnerships":[{"partner_name":"Bioprojet Société Civile de Recherche","partnership_type":"licensing","description":"2017 LCA grants exclusive U.S. rights to commercialize pitolisant; 2022 LCA grants exclusive U.S. and Latin America rights for next-generation pitolisant formulations.","start_date":null},{"partner_name":"Teijin Pharma","partnership_type":"licensing","description":"Original innovator of BP1.15205 orexin 2 receptor agonist; rights sublicensed through Bioprojet to Harmony in April 2024.","start_date":null},{"partner_name":"CiRC Biosciences, Inc.","partnership_type":"development","description":"June 2025 research collaboration, option and license agreement to co-develop CBS105 and CBS104 discovery-stage cell replacement therapy candidates.","start_date":null}],"affiliations":[],"origin":{"leaf":"e00a4f215ae1e025e86bf89ea28ba4ecfa52b2baf5cbb48f72c97ddf9854a70e","formula":"v2: sha256( sha256(content) || parent || source_accession )","content_sha256":"4f21ee51fa3ea85c4d050c7955718faad405608633bcef36a5b1535581b8f168","parent":"98ab06adbbb54fad064d3b59406d669e96027dd6e5fa7a5609c3df3cc26342b0","source":"0001104659-26-018859","chain":"sec.gov/EDGAR (retrieved over TLS, accession recorded) > origin.rootz.global extraction > this response","registry":"origin.rootz.global","verify":"Recompute it: sha256(sha256(<this response body minus the origin block>) || parent || source_accession). 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