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