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08.12.2025
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Harmony Biosciences Presents Clinically Meaningful Open-Label Extension Study Effectiveness Data for EPX-100 in Dravet Syndrome
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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 wi...
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02.12.2025
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Harmony Biosciences to Present New Open-Label Extension Data from Phase 3 ARGUS Trial at the 2025 American Epilepsy Society Annual Meeting
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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 – Dece...
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24.11.2025
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Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation
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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...
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20.10.2025
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19.11.2025
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Harmony Biosciences Announces Initiation of First-In-Human Study With Potential Best-In-Class Orexin 2 Receptor Agonist (BP1.15205) for Central Disorders of Hypersomnolence
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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...
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18.11.2025
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Harmony Biosciences to Participate in Upcoming Investor Conferences
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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: Tue...
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04.11.2025
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Harmony Biosciences Reports Strong Q3 2025 Financial Results; Recently Raised 2025 Revenue Guidance to $845-$865M
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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 n...
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23.10.2025
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Harmony Biosciences Preannounces Strong Q3 2025 WAKIX Performance; Raises 2025 Revenue Guidance
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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 numb...
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24.09.2025
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Harmony Biosciences Provides Update From Its Phase 3 RECONNECT Study of ZYN002 in Fragile X Syndrome
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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.
Kuma...
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26.08.2025
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Harmony Biosciences to Present Rare Epilepsy Data at the 36th International Epilepsy Congress
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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.
Poster presentations will highlight information from the company’s investigatio...
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21.08.2025
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Harmony Biosciences to Participate in 2025 Cantor Global Healthcare Conference
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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...
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22.07.2025
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Harmony Biosciences to Report Second Quarter 2025 Financial Results on August 5, 2025
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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 8...
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15.07.2025
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Harmony Biosciences to Participate in H.C. Wainwright "HCW@Home" Series
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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 Biosci...
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11.06.2025
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Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mous...
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05.06.2025
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Harmony Biosciences Strengthens Patent Position With Favorable Settlement in ANDA Litigation
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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 fo...
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04.06.2025
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Harmony Biosciences to Participate in Goldman Sachs 46th Annual Global Healthcare Conference
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the Goldman Sachs 46th 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...
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06.05.2025
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Harmony Biosciences Reports Strong Q1 2025 Financial Results, Highlights Advancement of Its Pipeline and Upcoming Catalysts, and Reaffirms 2025 Revenue Guidance
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced strong year-over-year revenue growth for WAKIX® of 20% in the first quarter 2025, on its way to a potential $1B+ opportunity in narcolepsy alone and poised for additional growth from its next-gen pitolisant development programs. The company has demonstrated four consecutive years of...
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29.04.2025
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Harmony Biosciences to Report First Quarter 2025 Financial Results on May 6, 2025
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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 800-267-6...
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08.04.2025
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Harmony Biosciences Presents Promising Open-Label Extension Data of ZYN002 in Fragile X Syndrome
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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 adults with Fragile X syndrome (FXS). The data showed clinically meaningful improvements in irritability-related s...
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03.04.2025
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Harmony Biosciences Appoints Biotech Leader Ron Philip to Its Board of Directors
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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, regulator...
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26.03.2025
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Harmony Biosciences to Participate in 24th Annual Needham Virtual Healthcare Conference
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming 24th 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 websi...
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24.03.2025
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Harmony Biosciences Names Adam Zaeske as Chief Commercial Officer to Lead the Next Phase of Commercial Growth as Its Portfolio Expands
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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 pharmaceuti...
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22.03.2025
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HRMY Investors Have Opportunity to Join Harmony Biosciences Holdings, Inc. Fraud Investigation with the Schall Law Firm
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The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Harmony Biosciences Holdings, Inc. (“Harmony” or “the Company”) (NASDAQ: HRMY) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and...
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04.03.2025
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Harmony Biosciences to Participate in Upcoming Investor Conferences
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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: Wednes...
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25.02.2025
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Harmony Biosciences Reports Strong 2024 Financial Results and Reiterates 2025 Net Revenue Guidance; Highlights 2025 Catalysts in Sleep/Wake and Fragile X Syndrome Development Programs
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced a record $201.3 million in net product revenues for the fourth quarter 2024, and full year 2024 net revenues of $714.7 million, ending the year with $576 million in cash, cash equivalents and investments on the balance sheet. The company has guided 2025 WAKIX® net revenues to $820 -...
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19.02.2025
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Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia
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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 remain...
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18.02.2025
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Harmony Biosciences to Report Fourth Quarter and Full Year 2024 Financial Results on February 25, 2025
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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...
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13.01.2025
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Harmony Biosciences Reports Strong 2024 Revenues, Provides 2025 Revenue Guidance and Highlights Key Pipeline Catalysts
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced strong preliminary, unaudited net product revenues for Q4 and full year 2024 of $201 million and $714 million, respectively. Building on this performance, the company is well positioned for a catalyst-rich 2025, with value-creating milestones anticipated every quarter. Harmony will...
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18.12.2024
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HARMONY BIOSCIENCES TO PRESENT AT THE 43RD ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE
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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...
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03.12.2024
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HARMONY BIOSCIENCES TO PARTICIPATE IN OPPENHEIMER MOVERS IN RARE DISEASE SUMMIT
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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....
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21.11.2024
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HARMONY BIOSCIENCES TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES
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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 Glo...
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31.10.2024
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Harmony Biosciences Holdings, Inc. Announces Pricing of Public Offering of Common Stock by Selling Shareholders
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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...
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29.10.2024
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Harmony Biosciences Holdings, Inc. Announces Commencement of Proposed Public Offering of Common Stock by Selling Shareholders
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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, L...
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29.10.2024
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HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2024 FINANCIAL RESULTS AND HIGHLIGHTS CATALYST-RICH, LATE-STAGE PIPELINE POISED TO DELIVER ONE OR MORE NEW LAUNCHES EVERY YEAR OVER NEXT FIVE YEARS
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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 Prog...
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16.10.2024
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HARMONY BIOSCIENCES TO REPORT THIRD QUARTER 2024 FINANCIAL RESULTS ON OCTOBER 29, 2024
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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...
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01.10.2024
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HARMONY BIOSCIENCES HIGHLIGHTS NEW DATA, ROBUST LATE-STAGE PIPELINE WITH NEAR-TERM VALUE CREATION OPPORTUNITIES AND ITS BOLD NEW VISION AT INVESTOR DAY
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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 idiopathi...
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26.09.2024
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HARMONY BIOSCIENCES TO HOST FIRST INVESTOR DAY ON OCTOBER 1, 2024
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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...
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21.08.2024
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HARMONY BIOSCIENCES TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES
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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 202...
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06.08.2024
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Harmony Biosciences Reports Strong Second Quarter 2024 Financial Results and Advances Pitolisant High-Dose Program Toward Expected PDUFA Date in 2028
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WAKIX® (pitolisant) Net Revenue of $172.8 Million for Second Quarter 2024; ~29% Growth Year-over-Year...
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