Harmony Biosciences Reports Q3 Financial Results on Track to Achieve More Than $1 Billion WAKIX Net Revenue and Announces Strong Multiple-Ascending Dose Data for Its Orexin Agonist BP-205, Supporting Potential Best-in-Class Profile
Globe Newswire•04/11/2026•07:30 ET
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Key Highlights
- ➤Q3 WAKIX revenue $268.9 million, up 12% year over year
- ➤2026 WAKIX revenue guidance reaffirmed at $1.0 billion to $1.04 billion
- ➤BP-205 multiple-ascending dose study showed favorable safety and once-daily pharmacokinetics
- ➤BP-205 Phase 1b data expected Q1 2027; Phase 2 studies targeted by mid-2027
- ➤Pitolisant GR NDA under FDA review with April 1, 2027 PDUFA date
Expert Statements
Jeffrey Dayno, President and Chief Executive Officer of Harmony Biosciences
“As I prepare to transition the President and CEO role to Peter on January 1, I believe Harmony is operating from a position of strength, with a durable and growing WAKIX franchise, the financial flexibility to invest in innovation, conviction to pursue strategic business development opportunities, and a pipeline led by BP-205 that has the potential to generate significant long-term value”
Jeffrey Dayno, President and Chief Executive Officer of Harmony Biosciences
“I am proud of the talented team and passionate organization we have built, which position Harmony for continued success in delivering innovative treatments to patients and sustained value for our shareholders.”
WAKIX (®) Net Revenue in Q3 of $269 Million; Driven by Strong Demand with 400 Net Patient Adds in the Quarter; Reiterates Full Year Guidance of $1.0B to $1.04B
Repeated Once-Daily Dosing with BP-205 in Multiple-Ascending Dose Study Reinforces Favorable Safety, Tolerability and Pharmacokinetic Profile Observed in Single-Ascending Dose Study
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