Welcome to our dedicated page for Harmony Biosciences Holdings news (Ticker: HRMY), a resource for investors and traders seeking the latest updates and insights on Harmony Biosciences Holdings stock.
Harmony Biosciences Holdings, Inc. develops and commercializes therapies for rare neurological diseases, with WAKIX® (pitolisant) as its commercial product for adult narcolepsy-associated cataplexy. News about HRMY centers on WAKIX revenue trends, market access and payer dynamics, intellectual-property protection, and product guidance.
Company updates also cover clinical and regulatory progress across its CNS pipeline, including pitolisant lifecycle programs and candidates such as EPX-100 for Dravet syndrome and Lennox-Gastaut syndrome. Recurring announcements include quarterly results, investor-conference presentations, executive and board changes, and pipeline data presentations at medical meetings.
Harmony Biosciences (NASDAQ: HRMY) reported 2025 net product revenue of $868.5M for WAKIX and Q4 revenue of $243.8M, ~22% year-over-year growth. The company reiterated 2026 WAKIX guidance of $1.0–$1.04B, cited recent ANDA settlements, a Q2 2026 NDA plan for pitolisant GR, and multiple late-stage pipeline programs.
Cash and investments totaled $882.5M at year-end; R&D and operating expenses increased as the company advances lifecycle and label-expansion efforts.
Harmony Biosciences (Nasdaq: HRMY) announced FDA approval of WAKIX (pitolisant) for treatment of cataplexy in pediatric narcolepsy patients aged 6 years and older.
WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy with or without cataplexy. The company is pursuing pediatric exclusivity (potential +6 months) and cites utility patents filed through 2044.
Harmony Biosciences (Nasdaq: HRMY) will report fourth quarter and full year 2025 financial results on February 24, 2026 before U.S. markets open. A conference call and webcast will be held on February 24, 2026 at 8:30 a.m. ET to discuss results.
Investors can join via domestic dial-in 800-274-7083 or international 203-518-9786 with passcode HRMYQ425. A live and replay webcast will be available on the company investor website.
Harmony Biosciences (Nasdaq: HRMY) reported preliminary, unaudited Q4 2025 net product revenue of ~$243 million and full-year 2025 net revenue of ~$868 million, a ~21% increase versus 2024. The company guided WAKIX revenue of $1.0–$1.04 billion for 2026 and noted ~8,500 average patients in Q4 2025 after adding ~400 patients. Harmony highlighted a late-stage CNS pipeline with five ongoing Phase 3 registrational trials, Phase 3 readouts for certain programs in 2026–2027, and a Phase 1 orexin-2 agonist (BP1.15205) with PK data expected mid-2026. The company also said the ZYN002 Fragile X program is being phased out and provided upcoming presentation details for the J.P. Morgan Healthcare Conference on January 13, 2026.
Harmony Biosciences (Nasdaq: HRMY) will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Jeffrey M. Dayno, M.D., President and CEO, is scheduled to present on Tuesday, January 13, 2026 at 4:30 p.m. PT / 7:30 p.m. ET. A live webcast will be available on Harmony's investor relations website.
Investors can view the presentation via the company's webcast page at https://ir.harmonybiosciences.com/.
Harmony Biosciences (Nasdaq: HRMY) presented initial open-label extension (OLE) data for EPX-100 in Dravet syndrome at the 2025 American Epilepsy Society meeting on Dec 8, 2025. Data from 18 OLE participants with ≥6 months exposure showed a median ~50% reduction in countable motor seizure frequency per 28 days (CMS-28) and 50% of participants achieved ≥50% CMS-28 reduction. EPX-100 was generally well tolerated with treatment exposure >2 years for some participants; the most common treatment-emergent adverse events (>5%) were seizures, pyrexia and upper respiratory tract infection.
The company said there were no significant gastrointestinal adverse events (2%) and no additional lab monitoring is required. Topline ARGUS trial readout expected in 2026; ARGUS and LIGHTHOUSE trials remain enrolling.
Harmony Biosciences (Nasdaq: HRMY) will present new open-label extension data from EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for Dravet syndrome at the 2025 American Epilepsy Society Annual Meeting, December 5–9, 2025, in Atlanta.
Posters will be on display Monday, December 8, from 8:00 am–2:00 pm ET, with two scheduled presentations from 12:00 pm–1:45 pm ET: Poster #3.353 on preliminary ARGUS open-label extension results and Poster #3.359 on a drug–drug interaction study of EPX-100 with selected CYP probe substrates. The ARGUS trial is currently enrolling; more trial details are available at argustrial.com.
Harmony Biosciences (Nasdaq: HRMY) reported positive pivotal bioequivalence results for a pitolisant gastro-resistant (GR) formulation and plans an NDA submission in early 2026 with a targeted PDUFA in Q1 2027. The pivotal BE study showed bioequivalence for 17.8mg pitolisant GR vs. 17.8mg WAKIX with AUC ratio 108.46% (90% CI 103.74–113.41) and Cmax ratio 99.65% (90% CI 91.95–108.00). Topline dosing-optimization data showed 100% of patients initiated at the 17.8mg therapeutic dose without titration. No new safety or tolerability issues were reported. Utility patent applications for pitolisant GR and pitolisant HD were filed, with potential exclusivity to 2044.
Harmony Biosciences (Nasdaq: HRMY) announced initiation of a Phase 1 first-in-human study dosing the first participant with BP1.15205, an investigational orexin 2 receptor (OX2R) agonist for narcolepsy, idiopathic hypersomnia and other central disorders of hypersomnolence.
The trial will assess safety, tolerability, pharmacokinetics and pharmacodynamics after single and multiple ascending doses in healthy and sleep-deprived volunteers. Topline clinical data are expected in 2026. Harmony holds an exclusive U.S. and Latin America license from Bioprojet Pharma; Bioprojet originally licensed BP1.15205 from Teijin Pharma.
Harmony Biosciences (Nasdaq: HRMY) said its management team will participate in three investor conferences in early December 2025: Citi's 2025 Global Healthcare Conference in Miami on December 2, Evercore's 8th Annual Healthcare Conference in Miami with a fireside chat on December 2 at 2:35 p.m. ET, and Piper Sandler's 37th Annual Healthcare Conference in New York with a fireside chat on December 3 at 10:30 a.m. ET.
A webcast of the fireside chats will be available on Harmony's investor relations website at https://ir.harmonybiosciences.com/.