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) 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/.
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.