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) 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/.
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.