Harmony Biosciences Achieves Bioequivalence Milestone for Pitolisant GR; PDUFA Dates Set for Late 2027

2025-12-26 03:21:42

Abstract generation in progress

Harmony Biosciences Holdings, Inc. (HRMY) announced encouraging outcomes from two critical studies on its pitolisant gastro-resistant formulation, positioning the company for a regulatory milestone next year. The key trial demonstrated that the 17.8 mg pitolisant GR dose maintains bioequivalence with the existing 17.8 mg marketed formulation of Wakix, the company’s FDA-approved narcolepsy treatment.

Clinical Progress Removes Treatment Barriers

Beyond bioequivalence confirmation, the dosing-optimization trial revealed a significant clinical advantage: all enrolled patients successfully initiated therapy at the full 17.8 mg therapeutic dose without requiring gradual dose escalation. This finding streamlines the patient experience and potentially accelerates treatment initiation compared to conventional titration protocols.

Regulatory Path and Market Timeline

Building on these results, Harmony Biosciences is positioning itself to file a new drug application (NDA) for pitolisant GR in early 2026. The company has already targeted PDUFA dates in the first quarter of 2027, establishing a clear pathway for regulatory review and potential approval. Successful NDA submission would expand the company’s narcolepsy treatment portfolio with an improved formulation.

Market Response

HRMY stock showed modest gains in pre-market activity, trading up 0.32% at $34.42, reflecting cautious investor sentiment following the announcement. The progression toward NDA filing represents a meaningful step in advancing Harmony’s pipeline and potentially capturing additional market share in the narcolepsy segment.

This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.