Data to be Presented at the Hot Topics in Child Neurology Podium Presentation Session at the American Academy of Neurology Annual Meeting 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 symptoms prevalent in individuals with FXS. There are currently no U.S. Food & Drug Administration (FDA) approved treatments for FXS. The data will be shared during a podium presentation at the American Academy o

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 commercialization of novel therapies. Prior to Orbital, he was Chief Executive Officer of Spark Therapeutics, where he led the commercial launch of a novel gene therapy to treat an inherited form of blindness, expanded its therapeutic platform to larger disease areas, and acquired new technologies and assets through business developm

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 website at https://ir.harmonybiosciences.com/. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, H

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 teams and transforming organizations in both the U.S. and Europe. He has broad functional experience spanning commercial strategy and operations, sales, marketing, market access, new product planning and finance. At Harmony, Zaeske will be responsible for leading the company's commercial organization, setting commercial strate

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 webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at https://ir.harmonybiosciences.com/. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neu

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 Pitolisant HD in Narcolepsy and IH to Initiate in Q4 2025 Topline Data Readout from Phase 3 Registrational Trial with ZYN002 in Fragile X Syndrome On Track for Q3 2025 Pitolisant Patent Position Strengthened with Favorable Settlement of First Generic Litigation Con

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 disappointed with this short-term setback, but our long-term strategy for pitolisant in IH remains firmly on track with our focus on Pitolisant HD," said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. "We made the decision to submit the sNDA based on our belief in pitolisant's overall bene

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 800-445-7795 (domestic) or 785-424-1699 (international), and reference passcode HRMYQ424. It is recommended that you dial in at least 10 minutes prior to the call. The live and replay webcast of the call will be available on the investor page of our website at https://ir.harmonybiosciences.com/. About Harmony Biosciences Harmony

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; Potential Approval in 2025 Q2 – Orexin/BP1.15205 Data Presentation at SLEEP 2025 Conference Q3 – Pivotal Phase 3 Topline Data for ZYN002 in Fragile X Syndrome Q4 – Initiation of Pitolisant-HD Pivotal Phase 3 Trial in Narcolepsy Robust, Catalyst-Rich Pipeline Includes U

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 available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/. About Harmony BiosciencesHarmony Biosciences is a pharmaceutical compan

Deutsche Bank initiated coverage of Harmony Biosciences with a rating of Buy and set a new price target of $55.00

H.C. Wainwright initiated coverage of Harmony Biosciences with a rating of Buy and set a new price target of $75.00

Raymond James resumed coverage of Harmony Biosciences with a rating of Outperform

UBS initiated coverage of Harmony Biosciences with a rating of Buy and set a new price target of $56.00

Citigroup initiated coverage of Harmony Biosciences with a rating of Buy and set a new price target of $48.00

BofA Securities downgraded Harmony Biosciences from Neutral to Underperform and set a new price target of $30.00

Goldman downgraded Harmony Biosciences from Neutral to Sell and set a new price target of $31.00 from $40.00 previously

Berenberg initiated coverage of Harmony Biosciences with a rating of Buy and set a new price target of $59.00

BofA Securities initiated coverage of Harmony Biosciences with a rating of Neutral and set a new price target of $35.00

Jefferies upgraded Harmony Biosciences from Hold to Buy and set a new price target of $61.00 from $57.00 previously

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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, regulatory approval, and commercialization of novel therapies. Prior to Orbital, he was Chief Executive Officer of Spark Therapeutics, where he led the commercial launch of a novel gene therapy to treat an inherited form of blindness, expanded its therapeutic platform to larger disease areas, and acquired new technologies and assets through business developm

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 teams and transforming organizations in both the U.S. and Europe. He has broad functional experience spanning commercial strategy and operations, sales, marketing, market access, new product planning and finance. At Harmony, Zaeske will be responsible for leading the company's commercial organization, setting commercial strate

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 opportunity. The Harmony Board of Directors has named Jeffrey M. Dayno, MD, Harmony's Executive Vice President and Chief Medical Officer, as interim CEO effective immediately. Jeff Aronin, Harmony's founder and Board chairman, will continue to lead the Board of Directors as well as

PLYMOUTH MEETING, Pa., Nov. 22, 2021 /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 Linda Szyper to the Company's Board of Directors. Ms. Szyper brings extensive healthcare and pharmaceutical knowledge with expertise anchored in more than 30 years of experience that spans both pharmaceutical sales and marketing as well as healthcare communications services. Mos

PLYMOUTH MEETING, Pa., May 18, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of John C. Jacobs, President and CEO of Harmony, to the Life Sciences Pennsylvania's (LSPA) Board of Directors, effective May 6, 2021. John Jacobs' election to the board is accompanied by other leaders representing the breadth, diversity and geographic reach of LS

PLYMOUTH MEETING, Pa., March 15, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of Sandip Kapadia as Chief Financial Officer effective March 29, 2021. Mr. Kapadia is an accomplished executive with more than two decades of operational experience in leading finance operations, supporting commercialization, raising capital and providing strategic guidance within the healthcare sector.  "We are very pleased to welcome Sandip to Harmony. His broad and deep f

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 Pitolisant HD in Narcolepsy and IH to Initiate in Q4 2025 Topline Data Readout from Phase 3 Registrational Trial with ZYN002 in Fragile X Syndrome On Track for Q3 2025 Pitolisant Patent Position Strengthened with Favorable Settlement of First Generic Litigation Con

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 800-445-7795 (domestic) or 785-424-1699 (international), and reference passcode HRMYQ424. It is recommended that you dial in at least 10 minutes prior to the call. The live and replay webcast of the call will be available on the investor page of our website at https://ir.harmonybiosciences.com/. About Harmony Biosciences Harmony

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 mid-2025, Extending Leadership in Sleep/Wake Beyond 2040s Highlights Most Advanced Development Program and Proven Serotonergic (5-HT2) Mechanism of Action For EPX-100 in Rare Epilepsies; Pivotal Phase 3 Trial in Dravet Syndrome Ongoing; Phase 3 Registrational Trial in

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 (domestic) or (203) 518-9765 (international), and reference passcode HRMYQ324. It is recommended that you dial in at least 10 minutes prior to the call. The live and r

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 U.S. Food and Drug Administration (FDA) Approval and Launched WAKIX for the Treatment of EDS in Pediatric Patients with Narcolepsy Providing the First and Only Non-Scheduled Treatment Option On Track to Submit Supplemental New Drug Application for Pitolisant in Idiopa

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) or (203) 518-9708 (international), and reference passcode HRMYQ224. It is recommended that you dial in at least 10 minutes prior to the call. The live and repl

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 Potential Extended Beyond 2040 With Next-Generation Formulations; Reports Positive Pharmacokinetic Data on Next-Generation Formulation 1 (NG1); PDUFA Expected in 2026 Strengthens Leadership Position in Sleep/Wake with Licensing of TPM-1116, a Highly Potent and Selective O

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 the acquisition of Epygenix Therapeutics, Inc., accelerating its growth strategy by adding a rare epilepsy franchise to its expanding late-stage pipeline of innovative CNS assets.

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 (domestic) or +1 (785) 424-1789 (international), and reference passcode HRMYQ124. It is recommended that you dial in at least 10 minutes prior to the call. The live

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 Pitolisant for the Treatment of Prader-Willi Syndrome; On Track to Initiate Phase 3 TEMPO Study in First Quarter 2024 2024 Net Product Revenue Projected Between $700 -$720 Million Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, P

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