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Harmony Biosciences reports $269M Q3 WAKIX sales and holds 2026 guidance

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

The company kept its 2026 WAKIX revenue guidance at $1.00B-$1.04B and reported favourable 14-day Phase 1 multiple-ascending-dose data for its orexin-2 agonist BP-205.

Harmony Biosciences reported third-quarter 2026 results on 4 November, with net product revenue from WAKIX (pitolisant) of $269M. The company recorded 400 net patient additions in the quarter and an average of 9,350 patients on therapy.

Harmony reiterated its 2026 WAKIX net revenue guidance of $1.00B to $1.04B. It also cited exclusivity for WAKIX through March 2030, noting that legal proceedings are ongoing.

On the pipeline, the company reported favourable data from a 14-day multiple-ascending-dose Phase 1 study of BP-205, an orexin-2 receptor agonist. Harmony expects Phase 1b data in the first quarter of 2027 and plans to start Phase 2 studies by mid-2027.

The summary provided does not give detailed safety, tolerability or efficacy findings from the BP-205 study, so the content of the data remains unclear.

What it means for your team

  • Market-access teams can note that the company's 2026 WAKIX revenue guidance is unchanged, and that it cites exclusivity to March 2030 while legal proceedings continue.
  • Teams tracking the orexin-2 agonist field should watch for Phase 1b data in Q1 2027 and Phase 2 starts by mid-2027.
  • Pharmacovigilance and regulatory teams should await fuller BP-205 data before drawing conclusions on its safety profile or development path.

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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