secwatch.observer — SEC 8-K summary
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Issuer:     Harmony Biosciences Holdings, Inc. (HRMY)
CIK:        0001802665
Form:       8-K
Filed at:   2023-03-29T23:59:59+00:00
Accession:  0001558370-23-004860
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1802665/000155837023004860/0001558370-23-004860-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1802665/000155837023004860/hrmy-20230329x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-23-004860

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