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Harmony Biosciences reports $268.9M Q3 WAKIX sales and clean early safety data for BP-205

🇺🇸 Harmony Biosciences Holdings, Inc. (HRMY) · Wed 04 Nov 2026

The company held its 2026 revenue guidance at $1.0–1.04 billion, said its pitolisant GR application is under FDA review, and released multiple-dose data for orexin agonist BP-205.

Harmony Biosciences said net revenue from WAKIX (pitolisant) in narcolepsy reached $268.9 million in the third quarter of 2026. The company announced the figure on 4 November 2026 and left its full-year guidance unchanged at $1.0 billion to $1.04 billion.

Harmony also released preliminary results from a 14-day multiple-ascending dose study of BP-205, its orexin agonist, in 94 healthy volunteers. The company reported no liver-related, visual or serious adverse events in the study.

On regulatory timelines, Harmony said its new drug application (NDA) for pitolisant GR is under review by the US Food and Drug Administration. The agency's PDUFA goal date is 1 April 2027. A PDUFA date is the target date by which the FDA aims to complete its review of an application.

The information comes from the company's announcement. No further detail on BP-205 dosing, study design or the safety findings was available, and the data are described as preliminary.

What it means for your team

  • The stated PDUFA date of 1 April 2027 gives regulatory teams a fixed milestone for the pitolisant GR review.
  • The absence of liver, visual and serious adverse events in BP-205's multiple-dose study is early and preliminary, from healthy volunteers only; pharmacovigilance teams will want to see fuller data.
  • Unchanged 2026 guidance of $1.0–1.04 billion suggests stable expectations for WAKIX in narcolepsy, which is relevant for market-access planning.

Company's press release (SEC filing): Harmony Biosciences Holdings, Inc. ↗

Article written by VigiEye from the official source (Harmony Biosciences Holdings, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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