Harmony Biosciences Announces Record Q2 2026 Revenue and Shares Initial Clinical Data for Its Orexin-2 Agonist BP-205 Reinforcing Potential Best-in-Class Profile

About this update from Harmony Biosciences Holdings, Inc.

WAKIX® Net Revenue Grew 30% Year over Year to $261.3 Million for Second Quarter 2026; Estimated Average Patients Increased 450 to 8,950; Reiterates 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 BillionPhase 1 SAD Data for BP-205 Demonstrate Favorable PK and Safety/Tolerability Profiles; Phase 1 MAD Data Expected in Q4 2026BP-205 IND Open in US; Initiating Phase 1b Study in Sleep-Deprived Healthy Volunteers in Q3; Data Expected Early 2027Initiating Phase 2 Trials for BP-205 in Mid-2027 to Evaluate Multiple CNS IndicationsPitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028Conference Call and Webcast Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q2 2026 net revenue for WAKIX® (pitolisant) of $261.3 million, delivering 30% year-over-year growth in its seventh year on the market. These results underscore continued strong demand for WAKIX, disciplined commercial execution across the franchise and sustained momentum through the first half of 2026. Average patients for the quarter were approximately 8,950, an increase in average patients of 450. WAKIX remains on track to achieve full-year net revenue guidance of $1.0 billion to $1.04 billion. The Company also announced encouraging single ascending dose (SAD) data from its Phase 1 study of BP-205, demonstrating favorable pharmacokinetic (PK) and safety/tolerability profiles that reinforce Harmony’s conviction in BP-205 as a potential best-in-class orexin-2 receptor (OX2R) agonist. These data support Harmony’s robust orexin development strategy, including initiating Phase 2 studies beginning in mid-2027 to evaluate multiple CNS indications. “Our record second-quarter revenue reflects sustained demand for WAKIX and keeps us firmly on track to deliver over $1 billion in revenue this year. With this strong foundation, we are aggressively advancing our pipeline, with our orexin-2 agonist BP-205 as the centerpiece, that we believe can create significant long-term value for both patients and shareholders,” said Jeffrey M. Dayno, MD, President and Chief Executive Officer of Harmony Biosciences. “The Phase 1 clinical PK and safety/tolerability data for BP-205 that we shared today, together with pre-clinical data demo...

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