New Drug Application to be submitted in early 2026; target PDUFA in Q1 2027 Utility patent applications filed with potential exclusivity to 2044 PLYMOUTH MEETING, Pa. / Nov 24, 2025 / Business Wire / 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... Read More

BP1.15205 is a differentiated chemical scaffold, demonstrating high potency and selectivity in preclinical studies with a favorable safety profile and the potential for once-daily dosing Topline clinical data expected in 2026 PLYMOUTH MEETING, Pa. / Nov 19, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced dosing of the first participant in a Phase 1 clinical trial of BP1.15205, an... Read More

PLYMOUTH MEETING, Pa. / Nov 18, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences. Citi's 2025 Global Healthcare Conference Location: Miami, FL Tuesday, December 2, 2025 8th Annual Evercore Healthcare Conference Location: Miami, FL Fireside Chat: Tuesday, December 2, 2025, at 2:35 p.m. ET... Read More

WAKIX® (pitolisant) Franchise Delivers Net Revenue of $239M in Q3 2025 (+29% YoY Growth) Record Increase in Average Number of Patients of Approximately 500 to Achieve 8,100 Average Patients in Q3 2025 Strong Cash Generation of $106M with $778M On Balance Sheet at end of Q3 2025 Pitolisant HD IND submitted; On Track to Initiate Phase 3 Trials in Narcolepsy and Idiopathic Hypersomnia in Q4 2025 Potential Best-In-Class Orexin 2... Read More

PLYMOUTH MEETING, Pa. / Oct 23, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced preliminary results for Q3 2025, highlighted by the following: WAKIX® (pitolisant) franchise delivered net revenue of approximately $239M in Q3 2025, representing 29% year-over-year revenue growth These results were driven by the highest ever quarterly increase in average number of patients of... Read More

PLYMOUTH MEETING, Pa. / Sep 24, 2025 / Business Wire / 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. Kumar Budur, M.D., M.S., Chief... Read More

PLYMOUTH MEETING, Pa. / Aug 26, 2025 / Business Wire / Harmony Biosciences Holdings, Inc . (Nasdaq: HRMY), today announced that it will present data from its rare epilepsy pipeline at the 36 th International Epilepsy Congress (IEC) being held August 30 – September 3, 2025, at the Lisbon Congress Centre in Lisbon, Portugal. Poster presentations will highlight information from the company’s investigation of EPX-100 (clemizole... Read More

PLYMOUTH MEETING, Pa. / Aug 21, 2025 / Business Wire / 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. A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at... Read More

WAKIX® (pitolisant) Franchise Continues Strong Growth with Net Revenue of $200.5M for Q2 2025 (+16% YoY Growth); Increases Average Patients by 400 to Achieve 7,600 Average Patients in Q2 2025 Phase 3 RECONNECT Study in Fragile X Syndrome (FXS) Designed to Confirm Positive Findings from the Phase 2/3 CONNECT Study; Opportunity to Address Unmet Needs of 80,000 Patients with FXS On Track to Begin First-in-Human Clinical Trial... Read More

PLYMOUTH MEETING, Pa. / Jul 22, 2025 / Business Wire / 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. To participate in the call, please dial 833-316-2483 (domestic) or... Read More

PLYMOUTH MEETING, Pa. / Jul 15, 2025 / Business Wire / 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. To register in advance, please use this link . A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at... Read More

BP1.15205 is a potentially best-in-class OX2R agonist being investigated in narcolepsy and other central disorders of hypersomnolence A first-in-human study is planned to start in 2H 2025; topline clinical data is anticipated in 2026 PLYMOUTH MEETING, Pa. / Jun 11, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of preclinical pharmacological effect data for... Read More

PLYMOUTH MEETING, Pa. / Jun 05, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX ® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of... Read More

PLYMOUTH MEETING, Pa. / Jun 04, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the Goldman Sachs 46 th Annual Global Healthcare Conference in Miami, FL on Monday, June 9, 2025, at 3:20 p.m., ET A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at... Read More

WAKIX® (pitolisant) Net Revenue of $184.7 Million for First Quarter 2025; Representing 20% Growth Year-over-Year; Reiterates Guidance of $820-$860M​ Net Income Grew 19% Year-over-Year, Building on Four Consecutive Years of Profitability; Increased Cash and Investments to Over $600 Million on Balance Sheet Completed Recruitment of Phase 3 Registrational Trial of ZYN002 in Fragile X Syndrome; On Track for Topline Data in Q3... Read More

PLYMOUTH MEETING, Pa. / Apr 29, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2025 financial results on Tuesday, May 6, 2025, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on May 6, 2025, at 8:30 a.m. ET to discuss the results. To participate in the call, please dial 800-267-6316 (domestic) or... Read More

Data to be Presented at the Hot Topics in Child Neurology Podium Presentation Session at the American Academy of Neurology Annual Meeting PLYMOUTH MEETING, Pa. / Apr 08, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of updated data from its Open-Label Extension (OLE) study (ZYN2-CL-017) evaluating the safety and effectiveness of ZYN002 in children, adolescents, and... Read More

PLYMOUTH MEETING, Pa. / Apr 03, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the appointment of Ron Philip to the Company's Board of Directors. Ron Philip is the President and Chief Executive Officer of Orbital Therapeutics. Ron has 30 years of experience building companies, leading organizational growth, and guiding teams through the development, regulatory approval, and... Read More

PLYMOUTH MEETING, Pa. / Mar 26, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming 24 th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025, at 3:00 p.m. ET. A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at... Read More

PLYMOUTH MEETING, Pa. / Mar 24, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Adam Zaeske as Executive Vice President and Chief Commercial Officer (CCO), effective March 31, 2025. The company’s current CCO, Jeffrey Dierks, is voluntarily stepping down for personal reasons. Zaeske brings 25 years of global leadership across the pharmaceutical industry, building... Read More

PLYMOUTH MEETING, Pa. / Mar 04, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences: Barclays Global Healthcare Conference Location: Miami, FL Tuesday, March 11, 2025 Leerink Partners Global Healthcare Conference Location: Miami, FL Fireside Chat: Wednesday, March 12, 2025, at 1:00 p.m. ET A... Read More

WAKIX® (pitolisant) Net Revenue of $201.3 Million for Fourth Quarter and $714.7 Million for Full Year 2024; Representing Growth of 23% in Year-Five on the Market 2025 WAKIX Net Revenue Guidance Between $820 - $860 Million; On Track toward a Potential $1 Billion+ Opportunity Committed to Leadership in Sleep/Wake with Next Generation Pitolisant Formulations and Orexin 2 Receptor Agonist; Phase 3 Registrational Trials with... Read More

PLYMOUTH MEETING, Pa. / Feb 19, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH). Harmony’s 2025 net revenue guidance of $820-$860 million remains unchanged. “We are... Read More

PLYMOUTH MEETING, Pa. / Feb 18, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report fourth quarter and full year 2024 financial results on Tuesday, February 25, 2025, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on February 25, 2025, at 8:30 a.m. ET to discuss the results. To participate in the call, please dial... Read More

WAKIX® (pitolisant) Preliminary Net Revenue of ~$201 Million for Fourth Quarter and ~$714 Million for Full Year 2024; Representing Growth of ~23% in Year-Five of Launch 2025 WAKIX Net Revenue Guidance Between $820 - $860 Million; On Track to a Potential $1 Billion+ Opportunity Value-Creating Catalysts Anticipated Every Quarter in 2025: - Q1 – FDA Decision on File Acceptance of Pitolisant sNDA for Idiopathic Hypersomnia;... Read More

PLYMOUTH MEETING, Pa. , Dec. 18, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Jeffrey M. Dayno, M.D., President and Chief Executive Officer, is scheduled to present at the conference on Wednesday, January 15, 2025, at 11:15 a.m. PT / 2:15 p.m. ET . A webcast of the fireside chat will be... Read More

PLYMOUTH MEETING, Pa. , Dec. 3, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming Oppenheimer Movers in Rare Disease Summit in New York, NY on Thursday, December 12, 2024 , at 9:00 a.m. ET . A webcast of the fireside chat will be available on the investor page of Harmony's website at... Read More

PLYMOUTH MEETING, Pa. , Nov. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences: Citi's 2024 Global Healthcare Conference Location: Miami Tuesday, December 3, 2024 Piper Sandler 36 th Annual Healthcare Conference Location: New York City Fireside Chat: Wednesday, December 4, 2024, at 8:30... Read More

PLYMOUTH MEETING, Pa. , Oct. 30, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) (the "Company") today announced the pricing of the previously announced underwritten public offering of an aggregate of 8,000,000 shares of the Company's common stock, par value $0.00001 per share ("Common Stock"), by Marshman Fund Trust II and Valor IV Pharma Holdings, LLC (together, the "Selling Shareholders") at a... Read More

PLYMOUTH MEETING, Pa. , Oct. 29, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) (the "Company") today announced the commencement of an underwritten public offering of up to 8,000,000 shares of the Company's common stock, par value $0.00001 per share ("Common Stock"), by Marshman Fund Trust II and Valor IV Pharma Holdings, LLC (together, the "Selling Shareholders"). The Selling Shareholders intend to... Read More

WAKIX (pitolisant) Net Revenue of $186.0 Million for Third Quarter 2024; Surpassed $2B in Cumulative Net Revenue in Less Than Five Years On Track to Submit sNDA for Pitolisant in Idiopathic Hypersomnia (IH) in Q4 2024 Based on Updated Strong and Sustained Efficacy Data from Long-Term Extension Study Next-Gen Pitolisant-GR and Pitolisant-HD Programs Advance; IND for Potential Best-In-Class, Novel Orexin-2 Agonist On Track for... Read More

PLYMOUTH MEETING, Pa. , Oct. 16, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report third quarter 2024 financial results on Tuesday, October 29, 2024 , before the open of the U.S. financial markets. Harmony will host a conference call and webcast on October 29, 2024 , at 8:30 a.m. ET to discuss the results. To participate in the call, please dial (800) 245-3047... Read More

PLYMOUTH MEETING, Pa. , Oct. 1, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), will be providing a comprehensive pipeline update at its Investor Day event today, showcasing new data from its orexin-2 receptor agonist, next-generation pitolisant programs, and long-term extension data from its pitolisant program in idiopathic hypersomnia. The company will also provide program updates from its strategic... Read More

PLYMOUTH MEETING, Pa. , Sept. 26, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), will provide an overview of its robust, late-stage pipeline at an in-person Investor Day at 8:30 a.m. ET on October 1 in New York City . Members of Harmony's senior leadership team along with therapeutic area key opinion leaders will present to investors and research analysts the following: Highlights of the company's... Read More

PLYMOUTH MEETING, Pa. , Aug. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences: Wells Fargo 2024 Healthcare Conference Location: Boston Fireside Chat: Thursday, September 5, 2024 , at 9:30 a.m. ET 2024 Cantor Global Healthcare Conference Location: New York City Fireside Chat: Tuesday,... Read More

WAKIX ® (pitolisant) Net Revenue of $172.8 Million for Second Quarter 2024; ~29% Growth Year-over-Year Next Generation Pitolisant High-Dose (HD) Program Advances Based on Pilot Pharmacokinetic (PK) Data with PDUFA Date Expected in 2028 to Extend Pitolisant Franchise Beyond 2040 WAKIX Patent Upheld Again - U.S. Patent and Trademark Office (USPTO) Issues Final Denial After Two Attempts to Challenge the WAKIX Patent Received... Read More

PLYMOUTH MEETING, Pa. , July 23, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report second quarter 2024 financial results on Tuesday, August 6, 2024 , before the open of the U.S. financial markets. Harmony will host a conference call and webcast on August 6, 2024 , at 8:30 a.m. ET to discuss the results. To participate in the call, please dial (800) 225-9448 (domestic)... Read More

FDA confirms the favorable benefit-risk profile of WAKIX Harmony Biosciences focused on continuing to advance its pipeline assets across three rare CNS franchises; anticipates at least one new product or indication launch annually over the next five years PLYMOUTH MEETING, Pa. , June 25, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that the U.S. Food and Drug Administration denied... Read More

PLYMOUTH MEETING, Pa. , June 24, 2024 /PRNewswire/ -- 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 excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. The FDA separated the submission into two sNDAs for... Read More

PLYMOUTH MEETING, Pa. , June 5, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) presented data from its Phase 2 signal detection study showing that pitolisant reduced excessive daytime sleepiness (EDS) and fatigue in adults with Myotonic dystrophy Type 1 (DM1). "More than 80 percent of DM1 patients experience EDS and fatigue, which patient-reported outcomes research has shown to be nearly as debilitating as the... Read More

PLYMOUTH MEETING, Pa. , May 28, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming Goldman Sachs 45 th Annual Global Healthcare Conference in Miami Beach, FL on Monday, June 10, 2024 , at 9:20 a.m. ET . A webcast of the fireside chat will be available on the investor page of Harmony's website at... Read More

WAKIX ® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia Planned for Second Half 2024 On Track Toward Pediatric Exclusivity to Extend WAKIX Exclusivity to September 2030: Pediatric Narcolepsy sNDA PDUFA Date of June 21, 2024; PWS Phase 3 TEMPO Study Initiated in March 2024 Pitolisant Franchise Revenue... Read More

Lead Candidate, EPX-100, Holds Orphan Drug and Rare Pediatric Disease Designations EPX-100 in Pivotal Registrational Trial for Dravet Syndrome; Topline Data Expected in 2026 Plan to Initiate Phase 3 Trial for Lennox-Gastaut Syndrome in Second Half of 2024 Potential Billion Dollar Plus Market Opportunity in Rare Epilepsy PLYMOUTH MEETING, Pa. , April 30, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY), today announced... Read More

PLYMOUTH MEETING, Pa. , April 16, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2024 financial results on Tuesday, April 30, 2024 , before the open of the U.S. financial markets. Harmony will host a conference call and live webcast on April 30, 2024 , at 8:30 a.m. ET to discuss the results. To participate in the call, please dial (800) 579-2543... Read More

PLYMOUTH MEETING, Pa. , April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R... Read More

PLYMOUTH MEETING, Pa. , April 3, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY) has initiated its global Phase 3 registrational trial, the TEMPO study, to evaluate the safety and efficacy of pitolisant as a treatment for excessive daytime sleepiness (EDS) and behavioral symptoms in patients aged six years and older with Prader-Willi syndrome (PWS). The TEMPO study initiation follows a... Read More

PLYMOUTH MEETING, Pa. , March 26, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming 23 rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024 , at 9:30 a.m. ET . A webcast of the fireside chat will be available on the investor page of Harmony's website at... Read More

PLYMOUTH MEETING, Pa. , Feb. 28, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc . (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences: Leerink Partners Global Biopharma Conference 2024 Location: Miami Fireside Chat: Monday, March 11, 2024 , at 12:40 p.m. ET Barclays 26th Annual Global Healthcare Conference Location: Miami Fireside Chat:... Read More

WAKIX® (pitolisant) Net Revenue of $168.4 Million for Fourth Quarter and $582.0 Million for Full Year 2023; Representing Growth of ~31% and ~33%, Respectively U.S. Food and Drug Administration (FDA) Granted Priority Review for WAKIX in Pediatric Narcolepsy; PDUFA Date of June 21, 2024 Meeting with FDA to Discuss Idiopathic Hypersomnia Development Program Scheduled for March 2024 FDA Granted Orphan Drug Designation to... Read More

Prescription Drug User Fee Act date is June 21, 2024 PLYMOUTH MEETING, Pa. , Feb. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) granted priority review for its supplemental New Drug Application (sNDA) for WAKIX ® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age... Read More

PLYMOUTH MEETING, Pa. , Feb. 20, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS). "The decision to grant Orphan Drug designation to pitolisant indicates that it could be a promising treatment option for people living with Prader-Willi syndrome,"... Read More

PLYMOUTH MEETING, Pa. , Feb. 8, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report fourth quarter and full year 2023 financial results on Thursday, February 22, 2024 , before the open of the U.S. financial markets. Harmony will host a conference call and live webcast on February 22, 2024 , at 8:30 a.m. ET to discuss the results. To participate in the call, please dial... Read More

WAKIX ® (pitolisant) Preliminary Net Revenue of ~$168 Million for Fourth Quarter and ~$582 Million for Full Year 2023; Representing Growth of ~31% and ~33%, Respectively Average Number of Patients on WAKIX Increased to ~6,150 2024 Net Product Revenue Projected Between $700 - $720 Million $50 Million Common Stock Repurchase in Fourth Quarter Bringing 2023 Total to $100 Million ; Expect to Continue Opportunistic Share... Read More

PLYMOUTH MEETING, Pa. , Jan. 3, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced its participation in the 42 nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Jeffrey M. Dayno , M.D., President and Chief... Read More

PLYMOUTH MEETING, Pa. , Dec. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY) today announced positive topline results from its Phase 2 signal detection study evaluating the safety and efficacy of pitolisant in adult patients with myotonic dystrophy type 1 (DM1). A clinically meaningful improvement was demonstrated on the primary efficacy endpoint, the change from... Read More

PLYMOUTH MEETING, Pa. , Dec. 5, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, will present caregiver-reported impacts of 22q11.2 deletion syndrome (22q) and data from the Phase 2 INSPIRE trial at the American College of... Read More

PLYMOUTH MEETING, Pa. , Nov. 16, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's management team will participate in a fireside chat at the upcoming Piper Sandler 35 th Annual Healthcare Conference in New... Read More

PLYMOUTH MEETING, Pa. , Nov. 15, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, ranks 25 th on the Deloitte Technology Fast 500 ™ for growing revenues 7,204% from fiscal year 2019 to 2022. Harmony Biosciences ranked 8 th among the 87 life... Read More

PLYMOUTH MEETING, Pa. , Nov. 8, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the appointment of Peter Anastasiou to the Company's Board of Directors. Peter is Chief Executive Officer of a development stage company... Read More

Continued Strong Growth with WAKIX® (pitolisant) Net Revenue of $160.3 Million for Third Quarter 2023; Increased ~37% Year-over-Year Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,800 for Third Quarter 2023 Remain Committed and Continue to Pursue Idiopathic Hypersomnia Indication; Next Step to Meet with FDA Informed by Review of Full Data Set Expanded and Diversified Pipeline with Acquisition of... Read More

PLYMOUTH MEETING, Pa. , Oct. 26, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, has selected the latest round of nonprofit organizations for its Patients at the Heart and Progress at the Heart awards. These awards provide funding support to nonprofit... Read More

PLYMOUTH MEETING, Pa. , Oct. 17, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will report third quarter 2023 financial results on Tuesday, October 31, 2023 , before the open of the U.S. financial markets. Harmony... Read More

PLYMOUTH MEETING, Pa. , Oct. 13, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced topline results from the INTUNE study in patients with idiopathic hypersomnia (IH). Kumar Budur , M.D., Chief Medical Officer at Harmony... Read More

New product in development diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Zygel™ in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11.2 deletion syndrome PLYMOUTH MEETING, Pa. , Oct. 11, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony")... Read More

PLYMOUTH MEETING, Pa. , Oct. 5, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the presentation of new secondary endpoint data, including improvements in behavioral disturbances, from its Phase 2 signal-detection study... Read More

PLYMOUTH MEETING , Pa. , Sept. 27, 2023 /PRNewswire/ -- In connection with the previously announced merger agreement, Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), today announced that Xylophone Acquisition Corp., a wholly owned subsidiary of Harmony, has extended the expiration of its tender offer to acquire all of the outstanding shares of common stock of Zynerba Pharmaceuticals, Inc. ("Zynerba") (Nasdaq:... Read More

PLYMOUTH MEETING, Pa. , Sept. 20, 2023 /PRNewswire/ -- Jeffrey M. Dayno, M.D., President & CEO of Harmony Biosciences , was named to the 2023 PharmaVoice 100 list for his unwavering commitment to bring clinical innovation and hope to patients living with rare neurological diseases. Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY) is a pharmaceutical company dedicated to developing and commercializing innovative... Read More

PLYMOUTH MEETING, Pa. , Sept. 13, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's management team will participate in a fireside chat at the upcoming 2023 Cantor Global Healthcare Conference in New York, NY... Read More

PLYMOUTH MEETING, Pa. , Sept. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of idiopathic hypersomnia (IH). The FDA's... Read More

PLYMOUTH MEETING, Pa. , Aug. 28, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today commented on the favorable decision by the U.S. Patent and Trademark Office (USPTO) to deny a Petition for Reexamination concerning a patent covering... Read More

PLYMOUTH MEETING, Pa. and DEVON, Pa. , Aug. 14, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced a definitive agreement to acquire Zynerba Pharmaceuticals, Inc. ("Zynerba") (Nasdaq: ZYNE), a leader in innovative pharmaceutically-produced... Read More

WAKIX® (pitolisant) Net Revenue Increased ~25% Year-over-Year to $134.2 Million for Second Quarter 2023 Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,450 for Second Quarter 2023 Exited Second Quarter 2023 With ~5,600 Patients on WAKIX Completed Enrollment in Phase 3 Idiopathic Hypersomnia (IH) INTUNE Study; On-track for Topline Data in Fourth Quarter 2023 Plans to Initiate Prader-Willi Syndrome... Read More

PLYMOUTH MEETING, Pa. , Aug. 1, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that its Board of Directors authorized the repurchase of up to $125 million of the Company's common stock. "Our strong balance sheet and cash... Read More

PLYMOUTH MEETING, Pa. , July 27, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced it has entered into a new $185 million senior secured term loan facility with a bank syndicate. Harmony intends to use the net proceeds from the term loan and... Read More

PLYMOUTH MEETING, Pa. , July 25, 2023 /PRNewswire/ -- Harmony Biosciences selected the latest round of nonprofit organizations for its Patients at the Heart and Progress at the Heart awards, which provide funding toward interdisciplinary community initiatives that address complex challenges facing people living with sleep disorders and rare neurological diseases. Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY),... Read More

PLYMOUTH MEETING, Pa. , July 20, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, has successfully completed an End-of-Phase 2 meeting with FDA regarding its clinical development plan evaluating pitolisant as a potential treatment for excessive daytime... Read More

PLYMOUTH MEETING, Pa. , July 18, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will report second quarter 2023 financial results on Tuesday, August 1, 2023 , before the open of the U.S. financial markets. Harmony... Read More

PLYMOUTH MEETING, Pa. , June 6, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the presentation of safety and efficacy data from a Phase 2 proof-of-concept study evaluating pitolisant for the treatment of excessive daytime sleepiness (EDS)... Read More

PLYMOUTH MEETING, Pa. , May 30, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's management team will participate in a fireside chat at the upcoming Goldman Sachs 44th Annual Global Healthcare Conference in... Read More

PLYMOUTH MEETING, Pa. , May 25, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that its Phase 3 registrational INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH) has completed... Read More

Late-breaking Phase 2 proof-of-concept study in Prader-Willi syndrome accepted for poster presentation PLYMOUTH MEETING, Pa. , May 10, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that new safety and efficacy data from a Phase 2... Read More

WAKIX ® (pitolisant) Net Revenue Increased ~40% Year-over-Year to $119.1 Million for First Quarter 2023 Average Number of Patients on WAKIX Increased ~1,200 Year-over-Year to ~5,100 for First Quarter 2023 Exited First Quarter 2023 With ~5,200 Patients on WAKIX WAKIX Surpassed $1 Billion in Cumulative Net Revenue Since Launch Anticipate Topline Data in Fourth Quarter 2023 in Phase 3 Idiopathic Hypersomnia (“IH”) INTUNE Study... Read More

PLYMOUTH MEETING, Pa. , April 24, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Jeffrey M. Dayno , M.D., has been appointed President and Chief Executive Officer by the Company's Board of Directors and has been... Read More

PLYMOUTH MEETING, Pa. , April 20, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will report first quarter 2023 financial results on Tuesday, May 2, 2023 , before the open of the U.S. financial markets. Harmony... Read More

PLYMOUTH MEETING, Pa. , March 29, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced an accelerated timeline for completing its Phase 3 INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with... Read More

PLYMOUTH MEETING, Pa. , March 6, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's management team will participate in the following upcoming investor conferences: Oppenheimer 33rd Annual Healthcare Conference... Read More

The annual funding programs support patient-centric initiatives within rare neurological disease and sleep disorder communities Applications for Patients at the Heart and Progress at the Heart open today, Tuesday, February 28 , timed to "Rare Disease Day" PLYMOUTH MEETING, Pa. , Feb. 28, 2023 /PRNewswire/ -- Community and nonprofit organizations throughout the country that are working to support patient-centric initiatives... Read More

WAKIX ® (pitolisant) Net Revenue Increased ~41% Year-over-Year to $128.3 Million for Fourth Quarter 2022; ~43% to $437.9 Million for Full Year 2022 Achieved Net Income of $181.5 Million for Full Year 2022 Average Number of Patients on WAKIX Increased to ~4,900 Continued Strong Momentum in Phase 3 Idiopathic Hypersomnia (“IH”) INTUNE Study Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa.,... Read More

Recognition reinforces strong company culture and employee experience PLYMOUTH MEETING, Pa. , Feb. 17, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for people with rare neurological diseases, today announced the company has earned the Great Place to Work® recognition for the fifth year in a row.... Read More

PLYMOUTH MEETING, Pa. , Feb. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (NASDAQ: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will report fourth quarter and full year 2022 financial results on Tuesday, February 21, 2023 , before the open of the U.S. financial... Read More

PLYMOUTH MEETING, Pa. , Jan. 6, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (" Harmony " or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that John C. Jacobs is stepping down as President and Chief Executive Officer and a member of the Board of Directors to pursue another... Read More

PLYMOUTH MEETING, Pa. , Dec. 22, 2022 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that President and CEO, John C. Jacobs will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11,... Read More