Harmony Biosciences reported a 17% year-over-year growth for WAKIX in the first quarter of 2026 and detailed four strategic priorities focused on long-term growth.

Key takeaways:

  • Harmony Biosciences reported $215.4 million in Q1 2026 net revenue for WAKIX and reinforced its full-year guidance of over $1 billion.
  • The company outlined four strategic pillars, prioritizing the protection and continued growth of the pitolisant franchise.
  • Pipeline advancements include the orexin-2 receptor agonist BP-205, which is on track for clinical data in mid-2026.
  • Harmony is renewing its emphasis on business development opportunities with revenue potential in the 2028 to 2032 timeframe.

Harmony Biosciences Holdings Inc reported Q1 2026 net product revenue of $215.4 million, delivering 17% year-over-year growth for WAKIX. Following this performance, the company reinforced its 2026 full-year revenue guidance of $1.0 billion to $1.04 billion and outlined progress across four strategic priorities intended to drive long-term value.

“Harmony is well-positioned for long-term growth, and we are focused on four key pillars to drive value creation. First, protect the pitolisant franchise to ensure durability into the 2030s, supported by multi-layered intellectual property. Second, continued growth of the pitolisant franchise in an evolving market by advancing new formulations and differentiated approaches to solidify our leadership in the sleep/wake market. Third, drive value from our pipeline, led by BP-205 (also known as BP1.15205), which has the potential to be a highly differentiated and best-in-class orexin-2 agonist across multiple indications. And fourth, a renewed emphasis on business development with a goal to transact on opportunities with revenue potential in the 2028–2032 timeframe,” says Jeffrey M. Dayno, MD, president and CEO of Harmony Biosciences, in a release. “Executing on these four pillars positions us well to deliver innovative treatments for patients and generate long-term value for shareholders.”

1. Protect the Pitolisant Franchise

  • ANDA settlements: Three additional abbreviated new drug application (ANDA) settlements were reached in Q1, bringing the total settlements to six of the seven ANDA filers.
  • Acquired new IP: Acquired an exclusive license to an issued patent out to 2042 for a novel amorphous form of pitolisant, providing Harmony with new development opportunities in broader central nervous system (CNS) patient populations.
  • Strong IP protection/exclusivity: Harmony’s pitolisant IP estate is multi-layered and supports WAKIX exclusivity into 2030, with potential protection of the franchise into the 2040s via additional patents and applications.
  • Filed lawsuit: Harmony Biosciences and Novitium filed a patent infringement lawsuit in April against AET Pharma US and Sandoz, alleging infringement of patents covering an amorphous form of pitolisant hydrochloride.

2. Continued Pitolisant Franchise Growth in an Evolving Market

  • First quarter 2026 net product revenue for WAKIX was $215.4 million, compared to $184.7 million for the same period in 2025.
  • On track to achieve over $1 billion in narcolepsy net sales in 2026.
  • Received Food and Drug Administration (FDA) approval of pediatric cataplexy indication on February 13, with full promotional efforts initiated immediately.
  • Pitolisant in Prader-Willi syndrome: Phase 3 topline data readout is expected in the second half of 2026, which fulfills a key regulatory requirement for six months of additional regulatory exclusivity.
  • Pitolisant GR (gastro-resistant): A new drug application submission is on track for Q2 2026. It is designed with an enteric coating meant to reduce the potential for gastrointestinal side effects, enabling patients to initiate treatment at a therapeutic dose without titration.
  • Pitolisant HD (high dose): Phase 3 registrational clinical trials are ongoing in narcolepsy and idiopathic hypersomnia, with topline data expected in 2027.

3. Drive Value from a Robust Pipeline

  • Orexin-2 receptor agonist BP-205: A Phase 1 clinical study is ongoing in Europe; on track for clinical pharmacokinetic, safety, and tolerability data in mid-2026.
  • A US investigational new drug submission for BP-205 is planned for mid-2026.
  • EPX-100 (clemizole hydrochloride): Actively enrolling in two global Phase 3 registrational trials in rare epilepsies, with topline data anticipated in the first half of 2027.

4. Renewed Emphasis on Business Development

  • Focused on opportunities with revenue potential in 2028–2032.
  • Prioritizing assets in phase 3, in-registration, or on-market.
  • Therapeutic areas of interest include sleep/wake, epilepsy, rare/orphan CNS, and CNS adjacencies beyond rare disease.

First Quarter 2026 Financial Results

The 17% year-over-year growth for WAKIX reflects continued demand within the narcolepsy market, which includes approximately 80,000 diagnosed patients in the US. Net income for the quarter was $32.5 million, or $0.55 per diluted share. As of March 31, 2026, Harmony had cash, cash equivalents, and investments of $870.5 million.

More on Harmony Biosciences:

New Data Suggests Best Orexin Receptor Agonists Are Still to Come
Harmony Advances First Human Study of Orexin 2 Agonist

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