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 Q3 2025 net product revenue of $239.5M for WAKIX, a 29% year‑over‑year increase, driven by a record ~500 patient increase to ~8,100 average patients. The company raised full‑year 2025 net revenue guidance to $845–$865M. GAAP net income was $50.9M ($0.87/share) and non‑GAAP adjusted net income was $63.5M ($1.08/share).
Cash, cash equivalents and investments totaled $778.4M at 9/30/2025. Development updates include pitolisant HD IND submitted with Phase 3 trials starting in Q4 2025, pitolisant GR topline bioequivalence readout on track for Q4 2025, first‑in‑human dosing for orexin‑2 agonist BP1.15205 planned in Q4 2025, and Phase 3 programs and epilespy trials progressing. ZYN002 Phase 3 RECONNECT missed its primary endpoint; program review is ongoing.
Harmony Biosciences (Nasdaq: HRMY) preannounced preliminary Q3 2025 results and raised full-year guidance. WAKIX net revenue was approximately $239M in Q3 2025, a 29% year-over-year increase. Average patients rose by about 500 in the quarter to 8,100 average patients in Q3 2025. Based on these results, Harmony increased 2025 revenue guidance to $845–$865M from a prior range of $820–$860M. The company will report full Q3 2025 financial results and host a conference call and webcast on November 4, 2025 at 8:30 a.m. ET.
Harmony Biosciences (Nasdaq: HRMY) announced that its Phase 3 RECONNECT Study of ZYN002 in Fragile X syndrome (FXS) did not meet its primary endpoint of improving social avoidance, primarily due to a higher than expected placebo response rate.
The study evaluated ZYN002, a transdermal cannabidiol gel, in FXS patients aged 3 to under 30 years. Despite the setback, the company remains focused on its pipeline, including upcoming Phase 3 trials for pitolisant HD in narcolepsy and idiopathic hypersomnia scheduled for Q4 2025.
Harmony Biosciences (Nasdaq: HRMY) announced upcoming presentations of data from its rare epilepsy pipeline at the 36th International Epilepsy Congress in Lisbon, Portugal from August 30 to September 3, 2025.
The company will present posters highlighting two ongoing Phase 3 clinical studies: the ARGUS trial investigating EPX-100 (clemizole hydrochloride) for Dravet syndrome and the LIGHTHOUSE trial for Lennox-Gastaut syndrome. The posters will be displayed from August 31 to September 2, with the ARGUS study presentation being featured in the ILAE YES (Young Epilepsy Section) poster tour.
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.