Harmony Biosciences accelerates Phase 3 INTUNE enrollment; topline data expected Q4 2023

Harmony Biosciences Holdings, Inc.

Enrollment completion expected Q2 2023, just over one year from trial initiation.
Topline data anticipated in Q4 2023.
Pre-specified interim sample size analysis allowed study to continue with original planned sample size.
Phase 3 INTUNE study: double-blind, placebo-controlled, randomized withdrawal in ~200 IH patients at ~60 U.S. sites.
Pitolisant (WAKIX) is approved for narcolepsy but not yet for idiopathic hypersomnia.

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