HRMY Harmony Biosciences Holdings, Inc.
Legal ·
Lupin Limited gets a license to launch a generic WAKIX no earlier than January 2030, or July 2030 with pediatric exclusivity, and the Delaware case will be dismissed.
We have not published a story on Harmony Biosciences Holdings yet. When there is news, it will appear here.
Harmony Biosciences Holdings, Inc. is a neuroscience company focused on rare neurological diseases across sleep/wake, rare epilepsy and neurobehavioral conditions. Its lead product, WAKIX (pitolisant), is described as a first-in-class molecule that enhances histamine signaling in the brain by binding to H3 receptors. WAKIX is approved for excessive daytime sleepiness and cataplexy in adults with narcolepsy, with later approvals for pediatric patients six years and older. The company says it is the only FDA-approved narcolepsy treatment that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. Net product revenue related to WAKIX was $868.5 million for the year ended December 31, 2025. Harmony has late-stage programs exploring pitolisant in idiopathic hypersomnia, Prader-Willi syndrome and myotonic dystrophy type 1. Its rare epilepsy programs include EPX-100, in two Phase 3 registrational trials for Dravet Syndrome and Lennox-Gastaut Syndrome, and EPX-200, in the pre-IND phase for developmental and epileptic encephalopathies. The company also holds a preclinical orexin 2 receptor agonist, BP1.15205, sublicensed from Bioprojet, and has a research collaboration with the related party CiRC Biosciences, Inc. on discovery-stage candidates.
| Product or program | What it is | Stage |
|---|---|---|
| WAKIX (pitolisant) | First-in-class H3 receptor antagonist/inverse agonist for narcolepsy | approved by FDA |
| Pitolisant GR | Gastro-resistant next-generation pitolisant formulation | clinical development |
| Pitolisant HD | High-dose next-generation pitolisant formulation | clinical development |
| EPX-100 | Serotonin (5HT-2) receptor agonist for rare epilepsy | Phase 3 |
| EPX-200 | Selective 5HT-2C agonist for developmental and epileptic encephalopathies | pre-IND |
| BP1.15205 | Orexin 2 receptor agonist for narcolepsy | preclinical |
| Line | FY2025 | FY2024 |
|---|---|---|
| Revenue | $868.5 million | $714.7 million |
| Research and development | $189.6 million | $145.8 million |
| Net income (loss) | $158.7 million | $145.5 million |
| Cash from operations | $348.2 million | $219.8 million |
| Cash and equivalents | $752.5 million | $453.0 million |
| Short-term investments | $22.8 million | $14.2 million |
Our latest story on this, dated Jun 5, 2025: "Harmony Biosciences settles WAKIX patent suit with Lupin, generic entry set for 2030". The story links the filing or release it is based on. Read the story.
Our latest story on this, dated Jun 5, 2025: "Harmony Biosciences settles WAKIX patent suit with Lupin, generic entry set for 2030". The story links the filing or release it is based on. Read the story.
Harmony Biosciences Holdings, Inc. trades under the ticker HRMY on NASDAQ.
Harmony Biosciences Holdings, Inc. is listed on NASDAQ. Our directory also records these other listings: BMV:HRMY.
The SEC Central Index Key (CIK) for Harmony Biosciences Holdings, Inc. is 1802665. Its filings are on SEC EDGAR.
58,236,393 shares as of 2026-07-31, per the cover page of its 10-Q filed 2026-08-04.
Our directory records Harmony Biosciences Holdings, Inc. under United States.
Our directory classifies Harmony Biosciences Holdings, Inc. as: Pharmaceuticals: Major. This is a directory classification, not a description of the pipeline.
The ISIN recorded for Harmony Biosciences Holdings, Inc. is US4131971040.
aibio.space lists Harmony Biosciences Holdings, Inc. among 2,820 public biotech companies and publishes its news here as stories appear.
SEC records list its state or country of incorporation as DE.
Harmony Biosciences Holdings, Inc. is a neuroscience company focused on rare neurological diseases across sleep/wake, rare epilepsy and neurobehavioral conditions. Its lead product, WAKIX (pitolisant), is described as a first-in-class molecule that enhances histamine signaling in the brain by binding to H3 receptors.
WAKIX (pitolisant): First-in-class H3 receptor antagonist/inverse agonist for narcolepsy Stage: approved by FDA.
Pitolisant GR: Gastro-resistant next-generation pitolisant formulation Stage: clinical development.
$868.5 million for the fiscal year ended Dec 31, 2025, as reported to the SEC.
Set up an at-the-market program to sell shares over time. SEC Form S-3ASR. Source
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