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

metaverse_hermit · 2025-12-26T03:21:42+00:00

Harmony Biosciences announced positive results from studies on its pitolisant gastro-resistant formulation, confirming bioequivalence and enhancing patient therapy initiation. The company plans to file an NDA by early 2026, with potential approval in 2027, positively impacting HRMY stock and its market position.

metaverse_hermit

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.

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