Harmony Biosciences reports record WAKIX revenue, posts Phase 1 data for BP-205

Harmony Biosciences Holdings reported Q2 2026 net revenue for WAKIX (pitolisant) of $261.3 million, marking 30% year-over-year growth in its seventh year on the market.¹ Average patients for the quarter were approximately 8,950, an increase in average patients of 450.¹ The company reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.¹

The company also disclosed single ascending dose (SAD) results from a Phase 1 study of BP-205, its orexin-2 receptor (OX2R) agonist. According to the release, the drug showed a short time to maximum plasma concentration in the range of 30 to 75 minutes, a mean half-life of approximately 25 hours across dose groups, dose-proportional exposure in Cmax and AUC, and no age or gender differences in PK parameters. The most common adverse events were headache, fatigue, and diarrhea in approximately 10%, 4%, and 3% of participants, respectively, with no serious or severe treatment-emergent adverse events reported.¹

Harmony said multiple ascending dose (MAD) data are expected in the fourth quarter, and that the US IND is open, with a Phase 1b study in sleep-deprived healthy volunteers to begin in the third quarter and data expected in early 2027. Phase 2 studies to evaluate multiple CNS indications are planned to begin in mid-2027.¹

On regulatory matters, the company noted its Pitolisant GR NDA was accepted in July, with a target PDUFA date of April 1, 2027, while Pitolisant HD is on track for Phase 3 topline data in 2027 and a target PDUFA date in 2028.¹

Financially, net income for the second quarter was $75.4 million, or $1.28 per diluted share, compared to $39.8 million, or $0.68 per diluted share, for the same quarter in 2025.¹ As of June 30, 2026, Harmony had cash, cash equivalents and investments of $962.5 million, compared to $882.5 million as of December 31, 2025.¹