Harmony Biosciences posts Q3 results, highlights BP-205 safety data

Harmony Biosciences reported third quarter 2026 results on November 4, 2026, alongside preliminary data from a multiple-ascending dose (MAD) study of its investigational orexin-2 receptor agonist BP-205. The 14-day repeated once-daily dosing results reinforced the safety, tolerability and pharmacokinetic profile seen earlier in the single-ascending dose portion of the study.¹ No liver or visual adverse events were reported, and no clinically significant cardiovascular events or EKG abnormalities were recorded.¹

The company said it is on track to report Phase 1b data in sleep-deprived healthy volunteers during the first quarter of 2027, with Phase 2 studies across multiple CNS indications expected to start by mid-2027.¹

On regulatory matters, Harmony said its pitolisant GR (gastro-resistant) tablet NDA has a PDUFA date of April 1, 2027. Phase 3 data for pitolisant HD is expected in 2027, with an anticipated PDUFA date in 2028. In patent litigation, the amorphous '920 patent trial has not yet been scheduled but is expected sometime in 2029, and a preliminary injunction hearing was scheduled for January 26, 2027, with a decision expected by February 14, 2027, matching the schedule Harmony had proposed to the court on October 26.¹

On leadership, Peter Anastasiou, the company's Senior Executive Vice President and Chief Operating Officer, will become President and CEO effective January 1, 2027, succeeding Jeffrey Dayno, MD, who will retire on December 31, 2026.¹

Financially, WAKIX delivered $269 million in net revenue for the quarter, driven by 400 net patient additions, with the company reiterating full-year guidance of $1.0 billion to $1.04 billion.¹ As of September 30, 2026, the company held cash, cash equivalents and investments totaling $1,051.6 million, up from $882.5 million at the end of 2025.¹