Harmony Biosciences(HRMY) Benzinga·2025-02-19 19:24Core Viewpoint - Harmony Biosciences received a Refusal to File (RTF) letter from the FDA for pitolisant for excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH), but the company's 2025 net revenue guidance remains unchanged at 860 million [1]. Group 1: Company Developments - The CEO of Harmony Biosciences expressed disappointment over the RTF letter but reaffirmed the long-term strategy for pitolisant in IH, with plans to initiate a Phase 3 registrational trial in Q4 2025 and a target PDUFA date in 2028 [2]. - Despite the primary outcome for EDS not reaching statistical significance in the Phase 3 INTUNE Study, open-label phase data indicated that patients experienced improvements on the Epworth Sleepiness Scale that were five times greater than clinically meaningful levels [2]. - Most patients in the long-term extension study achieved normal wakefulness levels and maintained this response beyond one year [3]. Group 2: Financial Performance - In January, Harmony reported preliminary net product revenue for Q4 of approximately 168.4 million year-over-year, exceeding the consensus estimate of 36.55 [5].