Harmony Biosciences Holdings, Inc., a commercial-stage pharmaceutical company, develops and commercializes therapies for patients with rare neurological disorders. Its product, WAKIX is a medication for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in the United States. The company was formerly known as Harmony Biosciences II, Inc. and changed its name to Harmony Biosciences Holdings, Inc. in February 2020. Harmony Biosciences Holdings, Inc. was incorporated in 2017 and is based in Plymouth Meeting, Pennsylvania.
IPO Year: 2020
Exchange: NASDAQ
Website: harmonybiosciences.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
9/10/2024 | $56.00 | Buy | UBS |
6/21/2024 | $48.00 | Buy | Citigroup |
1/2/2024 | $30.00 | Neutral → Underperform | BofA Securities |
9/25/2023 | $40.00 → $31.00 | Neutral → Sell | Goldman |
9/7/2023 | $59.00 | Buy | Berenberg |
4/20/2023 | $35.00 | Neutral | BofA Securities |
10/14/2022 | $57.00 → $61.00 | Hold → Buy | Jefferies |
8/3/2022 | $57.00 | Buy → Hold | Jefferies |
7/13/2022 | $55.00 | Buy → Neutral | Goldman |
7/7/2022 | $64.00 | Buy | Mizuho |
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 $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
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 (800) 579-2543 (domestic) or +1 (785) 424-1789 (international), and reference passcode HRMYQ423. It is recommended that you dial in at least 10 minutes prior to
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 Zynerba Pharmaceuticals; Zygel™ in Pivotal Phase 3 Trial for Fragile X syndrome Repurchased ~1.4 Million Shares of Common Stock for $50 Million in Third Quarter 2023; Board of Directors Authorized New $200 Million Share Repurchase Program Conference Call and Webcast
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 Biosciences said, "We are very encouraged by the magnitude of the response seen in the initial open-label treatment period, where 83% of patients completing this p
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") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it has completed its acquisition of Zynerba Pharmaceuticals, Inc. ("Zynerba") (NASDAQ:ZYNE).
8-K - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
10-Q - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
8-K - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
8-K - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
8-K - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
10-Q - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
8-K - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
ARS - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
8-K - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
DEFA14A - Harmony Biosciences Holdings, Inc. (0001802665) (Filer)
Needham analyst Ami Fadia reiterates Harmony Biosciences (NASDAQ:HRMY) with a Buy and maintains $52 price target.
Needham analyst Ami Fadia reiterates Harmony Biosciences (NASDAQ:HRMY) with a Buy and maintains $52 price target.
Across the recent three months, 7 analysts have shared their insights on Harmony Biosciences (NASDAQ:HRMY), expressing a variety of opinions spanning from bullish to bearish. The following table provides a quick overview of their recent ratings, highlighting the changing sentiments over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 5 2 0 0 0 Last 30D 1 0 0 0 0 1M Ago 0 0 0 0 0 2M Ago 2 0 0 0 0 3M Ago 2 2 0 0 0 Insights from analysts' 12-month price targets are revealed, presenting an average target of $49.71, a high estimate of $52.00, and a low estimate of $48.00. This current aver
Citigroup analyst David Hoang initiates coverage on Harmony Biosciences (NASDAQ:HRMY) with a Buy rating and announces Price Target of $48.
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).
Roy Bingham, CEO of BDSA, anticipates substantial growth in the U.S. cannabis market, projecting sales to reach nearly $46 billion by 2028. This growth would be primarily fueled by the expansion of adult-use markets and adoption of new licensed and regulated markets, both medical and recreational. Key states driving this surge include New York, New Jersey and potentially Florida and Ohio, Bingham says. Influence Of DEA Rescheduling Following the DEA's decision to reclassify cannabis to Schedule III, Bingham predicts this will open up new avenues for medical research and investment. "We expect major medical discoveries within five years," he stated, highlighting the potential for new pharm
Needham analyst Ami Fadia maintains Harmony Biosciences (NASDAQ:HRMY) with a Buy and raises the price target from $50 to $52.
4 - Harmony Biosciences Holdings, Inc. (0001802665) (Issuer)
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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
Jefferies downgraded Harmony Biosciences from Buy to Hold and set a new price target of $57.00
Goldman downgraded Harmony Biosciences from Buy to Neutral and set a new price target of $55.00
Mizuho initiated coverage of Harmony Biosciences with a rating of Buy and set a new price target of $64.00
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: BostonFireside Chat: Thursday, September 5, 2024, at 9:30 a.m. ET2024 Cantor Global Healthcare Conference Location: New York CityFireside Chat: Tuesday, September 17, 2024, at 3:05 p.m. ETA webcast of the fireside chats will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/.
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
- venBio promotes Yvonne Yamanaka, Ph.D. to Partner venBio today announced the closing of venBio Global Strategic Fund V ("venBio Fund V"), its fifth life sciences venture capital fund, exceeding its target and closing on approximately $528 million in capital commitments in an oversubscribed fundraise. The firm initiated the fundraise for Fund V in mid-April. Limited partners of Fund V include a broad range of institutional investors comprising sovereign wealth funds, corporate pensions, financial institutions, university endowments, medical institutions, foundations, family offices and funds-of-funds. Under the fund leadership of Managing Partners Richard Gaster, M.D., Ph.D., Corey Goo
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
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 the Citizen Petition filed by a short seller claiming that WAKIX is not safe and effective for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. The Agency's decision to reject the Petition was anticipated and confirms the Company's
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 administrative purposes to issue an approval for the treatment of EDS and a complete response for the treatment of cataplexy in pediatric patients (6 to <18 years of age) with narcolepsy.
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 primary symptoms of DM1, namely myotonia and muscle weakness,"1 said Kumar Budur, M.D., M.S., Chief Medical and Scientific Officer of Harmony Biosciences. "The fi
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 45th 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 https://ir.harmonybiosciences.com/. About Harmony BiosciencesAt Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases t
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.