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. (Nasdaq: HRMY) generates a steady flow of news centered on its commercial performance with WAKIX (pitolisant) and the advancement of a late-stage CNS pipeline. Recent press releases highlight preliminary and reported net product revenue for WAKIX, multi-year revenue growth, and guidance updates that frame the company’s evolution as a profitable, self-funding biotech focused on rare neurological diseases.
Investors following HRMY news can track updates on WAKIX in narcolepsy, including disclosures about average treated patient numbers, franchise growth and efforts to extend the pitolisant lifecycle through next-generation formulations such as pitolisant gastro-resistant (GR) and pitolisant high dose (HD). News items also cover clinical and regulatory milestones, such as pivotal bioequivalence results for pitolisant GR, Phase 3 trial plans and timelines, and the role of these formulations in potentially expanding indications and supporting additional exclusivity.
Harmony Biosciences’ news flow also features developments in its broader pipeline. This includes initiation and progress of the Phase 1 trial for BP1.15205, an investigational orexin-2 receptor agonist for central disorders of hypersomnolence, and Phase 3 ARGUS and LIGHTHOUSE trials evaluating EPX-100 (clemizole hydrochloride) in Dravet syndrome and Lennox–Gastaut syndrome. The company reports open-label extension data suggesting clinically meaningful seizure reductions and favorable tolerability for EPX-100, as well as program status for EPX-200 and ZYN002, including the outcome of the RECONNECT study in Fragile X syndrome.
Additional HRMY news includes participation in major healthcare and investor conferences, such as the J.P. Morgan Healthcare Conference and other sector events, where Harmony’s management presents commercial results, pipeline updates and strategic priorities. For investors, analysts and observers of rare neurological disease therapeutics, the HRMY news page offers a centralized view of earnings announcements, guidance changes, clinical trial readouts and portfolio decisions that shape the company’s trajectory.
Harmony Biosciences (NASDAQ:HRMY) announced its participation in the upcoming 2025 Cantor Global Healthcare Conference. The company's management team will engage in a fireside chat on September 4, 2025, at 2:10 p.m. ET in New York. Investors can access the webcast through the company's investor relations website.
Harmony Biosciences (NASDAQ:HRMY) reported strong Q2 2025 financial results, with WAKIX® net revenue reaching $200.5M, representing 16% year-over-year growth. The company increased its average patient count by 400 to 7,600 patients in Q2 2025.
Key pipeline developments include the upcoming Phase 3 Fragile X syndrome (FXS) topline data in Q3 2025, targeting an 80,000-patient market opportunity. The company plans to initiate Phase 3 trials for Pitolisant HD in narcolepsy and idiopathic hypersomnia in Q4 2025, targeting PDUFA dates in 2028.
Financial highlights include GAAP net income of $39.8M ($0.68 per diluted share) and non-GAAP adjusted net income of $53.8M ($0.92 per diluted share). The company maintains a strong cash position of $672.3M and reaffirms its 2025 revenue guidance of $820-860M.
Harmony Biosciences (Nasdaq: HRMY) has scheduled its second quarter 2025 financial results announcement for Tuesday, August 5, 2025, before U.S. markets open. The company will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the results.
Investors can participate by dialing 833-316-2483 (domestic) or 785-838-9284 (international) using passcode HRMYQ225. A live and replay webcast will be accessible on the company's investor relations website.
Harmony Biosciences (Nasdaq: HRMY) announced its management team will participate in the upcoming H.C. Wainwright "HCW@Home" virtual series. The fireside chat is scheduled for Thursday, July 17, 2025, at 10:00 a.m. ET. Investors can register in advance through a provided link, and a webcast will be available on the company's investor relations website.
Harmony Biosciences (Nasdaq: HRMY) has scheduled its first quarter 2025 financial results announcement for Tuesday, May 6, 2025, before U.S. financial markets open.
The company will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the quarterly results. Interested participants can join using:
- Domestic dial-in: 800-267-6316
- International dial-in: 203-518-9783
- Passcode: HRMYQ125
Participants are advised to dial in at least 10 minutes before the call begins. A live webcast and replay will be accessible through the investor relations section of Harmony's website at ir.harmonybiosciences.com.
Harmony Biosciences (NASDAQ: HRMY) presented updated data from its Open-Label Extension (OLE) study of ZYN002 for Fragile X Syndrome (FXS) treatment. The study demonstrated clinically meaningful improvements in irritability-related symptoms in patients.
Key findings include:
- Over 60% of participants achieved clinically meaningful improvement of ≥9 points on ABC-CFXS Irritability scores
- After three years, ~73% of patients experienced clinically meaningful improvements
- Treatment-related adverse events occurred in 12.9% of patients, with application site pain being most common (6.7%)
The study included 240 patients aged 3-17 years, with data collected from September 2018 to January 2024. The company expects topline data from its Phase 3 RECONNECT study in Q3 2025. Currently, there are no FDA-approved treatments for FXS, which affects approximately 80,000 individuals in the U.S.