# FDA Accepts Harmony Biosciences NDA for Pitolisant GR with PDUFA Date of April 1, 2027

> fda · REPORTED · 2026-08-04

The FDA accepted Harmony Biosciences's new drug application for Pitolisant GR in July 2026 and assigned a PDUFA target action date of April 1, 2027, with Harmony targeting a first-half 2027 launch if approved. The company is also running Phase 3 trials for Pitolisant HD in narcolepsy and idiopathic hypersomnia with topline results expected in 2027.

About Harmony Biosciences Holdings, Inc.: Harmony Biosciences is a pharmaceutical company focused on developing and commercializing therapies for patients with rare neurological diseases, with its lead product WAKIX approved for narcolepsy and a pipeline targeting additional CNS and sleep-wake disorders.

- Company: Harmony Biosciences Holdings, Inc.
- Sector: therapeutics
- Primary source: https://www.tradingkey.com/news/earnings/262076388-tradingkey

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.