Associated tags: Paragon, Plymouth Meeting, Pennsylvania, Heart, Empathy, Life, Patient, DSM-IV codes, Pharmaceutical industry, Harmony
Locations: RUSSIA, CALIFORNIA, LOS ANGELES, SEATTLE, WA, UTAH, PENNSYLVANIA, CA, SAN FRANCISCO, PA
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.
Key Points:
- 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.
- 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.
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.
Key Points:
- 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.
- Narcolepsy and other hypersomnolence disorders continue to be a large market opportunity with significant unmet medical need.
- Under the agreement, Harmony will pay Bioprojet an upfront license fee of $25.5 million for the exclusive right to develop, manufacture and commercialize TPM-1116 in the U.S. and Latin American territories.
- Finally, Harmony will pay a royalty rate in the mid-teens on sales of product in the licensed territories.
ODD,
Narcolepsy,
Prader–Willi syndrome,
TEMPO,
Cataplexy,
Patient,
Ageing,
EDS,
Safety,
Harmony,
Plasma protein binding,
FDA,
PWS,
Pitolisant,
Pharmaceutical industry Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with EDS.
Key Points:
- Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with EDS.
- "Our progress in expanding the clinical applications of pitolisant in PWS and in other rare diseases, remains promising.
- Pitolisant is marketed as WAKIX® in the U.S. and is FDA approved to treat EDS or cataplexy in adult patients with narcolepsy.
- Pitolisant is not approved for use in patients with PWS and is currently being evaluated as an investigational agent in this patient population.
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 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024, at 9:30 a.m. ET.
Key Points:
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 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024, at 9:30 a.m. ET.
Retrieved on:
Thursday, February 22, 2024
Acquisition,
PDUFA date,
Marketing,
Total,
Research,
Narcolepsy,
Share repurchase,
FDA,
Food,
Shanda,
Treatment,
Research and development,
Growth,
PDUFA,
Generator,
Track,
Fragile X syndrome,
Conference,
Prader–Willi syndrome,
GAAP,
Food and Drug Administration,
Administration,
Patient,
Initiate,
Development,
Benchmarking,
Bank statement Net product revenue for the quarter ended December 31, 2023 was $168.4 million, compared to $128.3 million for the same period in 2022.
Key Points:
- Net product revenue for the quarter ended December 31, 2023 was $168.4 million, compared to $128.3 million for the same period in 2022.
- The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 6,150 for the quarter ended December 31, 2023.
- Total Operating Expenses in the fourth quarter of 2023 included one-time Zynerba transaction related costs of $9.8 million.
- ET
We are hosting our fourth quarter and full year 2023 financial results conference call and webcast today at 8:30 a.m. Eastern Time.
Retrieved on:
Wednesday, February 28, 2024
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:
Key Points:
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:
Retrieved on:
Tuesday, February 20, 2024
Caregiver,
Orphan drug,
Narcolepsy,
FDA,
Food,
TEMPO,
Prader–Willi syndrome,
Phase 3,
Safety,
PWS,
EDS,
Patient,
Science,
Plasma protein binding,
Pharmaceutical industry 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).
Key Points:
- 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," said Kumar Budur, M.D., M.S., Chief Medical Officer at Harmony Biosciences.
- FDA Orphan Drug designation incentivizes the advancement of promising therapies for rare diseases by providing tax credits for clinical development, waivers for user fees, and seven years of market exclusivity following drug approval.
- In the upcoming Phase 3 registrational TEMPO study, Harmony will assess the safety and efficacy of pitolisant in treating EDS and behavioral disturbances in PWS.
Retrieved on:
Thursday, February 8, 2024
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.
Key Points:
- 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.
- 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 the call.
Retrieved on:
Wednesday, January 3, 2024
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 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
Key Points:
- 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 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
- Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony, is scheduled to present at the conference on Wednesday, January 10, 2024, at 5:15 p.m. PT/8:15 p.m.
- ET.
Retrieved on:
Thursday, December 7, 2023
Harmony,
Safety,
ESS,
EDS,
Narcolepsy,
Fatigue,
Data,
FSS,
Patient,
DM1,
OLE,
Cataplexy,
FDA,
Muscle weakness,
DSS,
Pitolisant,
Epworth Sleepiness Scale,
Myotonic dystrophy,
Myotonia,
News,
Somnolence,
Pharmaceutical industry,
Nursing,
Medicinal plants 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).
Key Points:
- 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).
- "In addition, a positive signal for pitolisant has been demonstrated for fatigue, suggesting it could be a potential new treatment option for this symptom as well.
- "The positive signals from this Phase 2 study are very encouraging, and support pitolisant as a potential treatment option for DM1."
- This Phase 2 signal detection study was a randomized, double-blind, placebo-controlled study in adults ages 18-65 with DM1.
