Harmony Biosciences Will Present HBS-301 Trial Data
The company will unveil new Phase 3 trial results for its narcolepsy treatment in October 2026.
Updated on Oct. 1, 2026 in Sleep Disorders
Harmony Biosciences is set to present findings from its Phase 3 clinical trials for HBS-301, an enteric-coated pitolisant tablet, at the 17th European Narcolepsy Days. The presentation will take place on October 2 and October 3, 2026, in Bern, Switzerland.
Why it matters
The presentation highlights progress in the development of HBS-301, which is being studied for its potential to treat excessive daytime sleepiness in patients with narcolepsy and idiopathic hypersomnia.
HBS-301 is an enteric-coated pitolisant tablet available in strengths up to 60 mg. The company is currently evaluating the treatment in Phase 3 clinical trials, specifically the ONSTRIDE-1 and ONSTRIDE-2 studies.
The players
Harmony Biosciences
Established in 2017 and headquartered in Plymouth Meeting, Pennsylvania, this pharmaceutical company focuses on developing therapies for rare neurological diseases.
The details
Harmony Biosciences will detail results from its ongoing research through a poster presentation at the upcoming event. The research evaluates the drug as a treatment for excessive daytime sleepiness.
Timeline
Harmony Biosciences was established in 2017.
The poster presentation for HBS-301 trials is scheduled for October 2, 2026, at 16:30 CEST.
A second poster presentation for HBS-301 trials will occur on October 3, 2026, at 12:30 CEST.
The Big Picture
This presentation serves as a progress update for the ONSTRIDE Phase 3 clinical trial program. The data release marks a critical step in advancing new pharmacological options for patients suffering from sleep-wake disorders.
The trial results may eventually expand treatment options for individuals struggling with excessive daytime sleepiness. If successful, the higher dosage strengths could provide improved symptom management for patients with narcolepsy or idiopathic hypersomnia.
The takeaway
Ongoing research into pitolisant derivatives aims to address the limitations of existing treatments for chronic sleepiness. Patients should monitor clinical updates to understand how these findings might eventually impact future care standards.
Further reading
For more information on current treatment developments, visit our Sleep Disorders section.
