secwatch.observer — SEC 8-K summary
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Issuer:     Harmony Biosciences Holdings, Inc. (HRMY)
CIK:        0001802665
Form:       8-K
Filed at:   2023-10-13T23:59:59+00:00
Accession:  0001558370-23-016428
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1802665/000155837023016428/0001558370-23-016428-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1802665/000155837023016428/hrmy-20231013x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-23-016428

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer