secwatch.observer — SEC 8-K summary
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Issuer:     Harmony Biosciences Holdings, Inc. (HRMY)
CIK:        0001802665
Form:       8-K
Filed at:   2026-01-12T23:59:59+00:00
Accession:  0001104659-26-002731
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Harmony Biosciences reports ~$868M FY2025 WAKIX revenue; guides $1.0-1.04B in 2026
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- Preliminary Q4 2025 WAKIX net revenue ~$243M; FY2025 ~$868M, up ~21% YoY.
- 2026 WAKIX net revenue guidance of $1.0-1.04B, on track for blockbuster status.
- Pitolisant GR NDA submission expected 2Q 2026; PDUFA 1Q 2027; aims to extend franchise into 2040s.
- Five ongoing Phase 3 reg. trials in CNS; topline data for pitolisant HD and EPX-100 in 2027.
- ZYN002 program in Fragile X discontinued; 22q deletion syndrome indication no longer pursued.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1802665/000110465926002731/0001104659-26-002731-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1802665/000110465926002731/hrmy-20260112x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-002731

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