Phase 3 INTUNE study for pitolisant in idiopathic hypersomnia misses primary endpoint

Harmony Biosciences Holdings, Inc.

Primary endpoint (ESS change) did not reach statistical significance between pitolisant and placebo in the randomized withdrawal phase.
83% of patients completing open-label phase responded with average ESS improvement of 9.4 points; 88% continued into long-term extension.
Positive trends favoring pitolisant observed on IHSS (approached significance) and Sleep Inertia Questionnaire.
Safety profile consistent with established pitolisant profile; no new safety signals.
Company plans to discuss full data with FDA to determine next steps for pitolisant in IH.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.