Harmony Biosciences Holdings, Inc. - Common Stock (HRMY)

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q1 2026 revenue of $215.4 million, delivering 17% year‑over‑year growth for WAKIX®. Performance during the quarter reflected continued strong demand, offset by market access headwinds observed every Q1, which were more pronounced this year. This follows the strongest three consecutive quarters in franchise history, and the Company reinforced 2026 full year revenue guidance. The Company also outlined progress across four strategic priorities that it believes underpin long‑term shareholder value.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2026 financial results on Thursday, May 7, 2026, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on May 7, 2026, at 8:30 a.m. ET to discuss the results.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will present encore open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2026 American Academy of Neurology Annual Meeting being held April 18 – 22 in Chicago, IL.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Glenn Reicin as Chief Financial Officer, effective immediately, supporting Harmony’s continued focus on strategic growth, financial strength, and long‑term value creation. Harmony is also reiterating its 2026 net product revenue guidance of $1.0 to $1.04 billion.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the appointment of Peter Anastasiou as Chief Operating Officer and updates to its Board of Directors, including the appointment of Troy Ignelzi as a director and the nomination of Geno J. Germano as a director for election at Harmony’s 2026 Annual Meeting of Shareholders.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that Harmony's management team will participate in a fireside chat at the upcoming 25th Annual Needham Virtual Healthcare Conference on Monday, April 13, 2026, at 9:30 a.m. ET.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will attend the following upcoming investor conferences.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings with reported revenue of $243.8 million for Q4 2025, representing 21% year-over-year revenue growth for WAKIX®. For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength as evidenced by six consecutive years of revenue growth and profitability. The company enters the year with significant momentum, reinforcing its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.

Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report fourth quarter and full year 2025 financial results on Tuesday, February 24, 2026, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on February 24, 2026, at 8:30 a.m. ET to discuss the results.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Jeffrey M. Dayno, M.D., President and Chief Executive Officer, is scheduled to present at the conference on Tuesday, January 13, 2026, at 4:30 p.m. PT / 7:30 p.m. ET.

BOSTON, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Beacon Biosignals, a leader in AI-driven neurophysiology and precision drug development, today announced a collaboration with Harmony Biosciences (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for rare neurological disorders, to incorporate quantitative electroencephalography (EEG) measurements into two of Harmony’s Phase 3 studies of HBS-301 for Narcolepsy and Idiopathic Hypersomnia.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the presentation of initial open-label extension (OLE) data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 (clemizole hydrochloride) for the treatment of Dravet syndrome (DS), which showed clinically meaningful reductions in seizure activity in participants with DS along with a favorable benefit-risk profile.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will highlight new open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive findings from both the pivotal BE and dosing optimization studies, Harmony is on track to submit a New Drug Application (NDA) for pitolisant GR in early 2026, targeting a PDUFA date in Q1 2027. With utility patent applications filed for pitolisant GR with potential exclusivity to 2044, Harmony is well positioned to extend the pitolisant franchise into the mid-2040s.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced dosing of the first participant in a Phase 1 clinical trial of BP1.15205, an investigational, potentially best-in-class, orexin 2 receptor (OX2R) agonist being developed for the treatment of narcolepsy, idiopathic hypersomnia and other central disorders of hypersomnolence. The Phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BP1.15205 after single and multiple ascending doses in healthy volunteers and sleep-deprived healthy subjects. Topline data are expected in 2026.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings of $239.5M for Q3 2025, representing 29% year-over-year revenue growth for WAKIX®. These results were driven by the highest ever increase in average number of patients of approximately 500 for the quarter, accelerating the trajectory toward blockbuster status for WAKIX in narcolepsy. The company continues to build on four consecutive years of revenue growth and profitability. With over $778 million in cash and investments at quarter end, Harmony has further strengthened its financial position, solidifying its unique profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced preliminary results for Q3 2025, highlighted by the following:

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS). The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will present data from its rare epilepsy pipeline at the 36th International Epilepsy Congress (IEC) being held August 30 – September 3, 2025, at the Lisbon Congress Centre in Lisbon, Portugal.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the 2025 Cantor Global Healthcare Conference in New York, N.Y., on Thursday, September 4, 2025, at 2:10 p.m. ET.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced plans to announce topline data from its phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome in Q3 2025. The company also announced 16% year-over-year revenue growth for WAKIX® in Q2 2025, driven by strong patient adds of 400 for the quarter, continuing its trajectory toward blockbuster status in narcolepsy and a potential $1B+ market opportunity. The company continues to build on four consecutive years of revenue growth and profitability. With over $672 million in cash and investments, Harmony has further strengthened its financial position, solidifying its unique profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report second quarter 2025 financial results on Tuesday, August 5, 2025, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on August 5, 2025, at 8:30 a.m. ET to discuss the results.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the virtual H.C. Wainwright "HCW@Home" series on Thursday, July 17, 2025, at 10:00 a.m. ET.