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Press Releases October 1, 2026 08:05 AM

Harmony Biosciences Announces Poster Presentation at the 17th European Narcolepsy Days

Harmony Biosciences to Present Phase 3 Trial Data of HBS-301 for Narcolepsy and Idiopathic Hypersomnia at European Narcolepsy Days

By Nina Shah
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HRMY

Harmony Biosciences Holdings, Inc. announced it will present a poster on its ongoing Phase 3 clinical trials (ONSTRIDE-1 and ONSTRIDE-2) for HBS-301, an investigational high-dose formulation of pitolisant, targeting excessive daytime sleepiness in narcolepsy and idiopathic hypersomnia. The presentation at the 17th European Narcolepsy Days highlights the company’s continued progress in developing treatments for rare neurological disorders.

Harmony Biosciences Announces Poster Presentation at the 17th European Narcolepsy Days
HRMY
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Key Points

  • Harmony Biosciences is conducting Phase 3 trials for HBS-301 in narcolepsy (ONSTRIDE-1) and idiopathic hypersomnia (ONSTRIDE-2).
  • HBS-301 is an optimized, high-dose enteric-coated tablet formulation of pitolisant.
  • The company is showcasing trial data at a prominent European medical conference, signaling advancement toward potential regulatory approval and commercialization.

PLYMOUTH MEETING, Pa., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will present a poster featuring information from its ongoing Phase 3 trials of HBS-301, including ONSTRIDE-1 in narcolepsy and ONSTRIDE-2 in idiopathic hypersomnia. This poster will be presented at the 17th European Narcolepsy Days, taking place October 2–3, 2026, in Bern, Switzerland.

Poster details are listed below:

Abstract Title:Phase 3, randomized, double-blind, placebo-controlled studies of HBS-301 for narcolepsy and idiopathic hypersomniaDate/Times:October 2, 16:30 (CEST)
October 3, 12:30 (CEST)  

About HBS-301 
HBS-301 is an investigational, optimized, high-dose formulation of enteric-coated pitolisant tablets. HBS-301 is being developed in multiple tablet strengths up to 60 mg to treat excessive daytime sleepiness and other symptoms in patients with narcolepsy or idiopathic hypersomnia (IH). HBS-301 is currently being evaluated in two phase 3 clinical trials. The ONSTRIDE-1 study in adult patients with narcolepsy and the ONSTRIDE-2 study in adult patients with IH. 

About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.

Harmony Biosciences Investor Contact:
Brennan Doyle
484-566-3685
[email protected]

Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
[email protected]


Risks

  • Clinical trial outcomes may not meet efficacy or safety endpoints, potentially delaying regulatory approval.
  • Competition within the rare neurological disorder pharmaceutical sector could impact market share and pricing.
  • Regulatory and reimbursement uncertainties in the U.S. and European markets may affect commercial success.

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