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Harmony Biosciences Holdings, Inc.

32.05

+0.12000.38%

Volume:13.24K

Turnover:425.77K

Market Cap:1.84B

PE:12.23

High:32.46

Open:32.27

Low:31.95

Close:31.93

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Overview Company News Filings

Harmony Biosciences (HRMY) Upgraded to Strong Buy: Here's Why

5 High Earnings Yield Value Stocks to Buy Amid Market Volatility

Harmony Biosciences Holdings Inc expected to post earnings of 74 cents a share - Earnings Preview

Mizuho Adjusts Price Target on Harmony Biosciences to $42 From $52, Keeps Outperform Rating

MT Newswires Live

Harmony Biosciences Holdings, Inc. : Deutsche Bank Cuts Target Price to $52 From $55

THOMSON REUTERS

Concerns Over Harmony Biosciences: FDA Setback, Patent Risks, and High-Risk Pipeline

Harmony Biosciences Stock Falls On FDA Setback For Pitolisant In Sleeping Disorder

Harmony Biosciences Price Target Maintained With a $75.00/Share by HC Wainwright & Co.

Harmony Biosciences: Buy Rating Affirmed Despite FDA Setback, Strong Growth Potential in Pitolisant Franchise and Pipeline Opportunities

BUZZ-Harmony Biosciences drops after FDA refuses to review hypersomnia drug

Harmony Biosciences Is Maintained at Buy by Needham

BRIEF-Harmony Biosciences Provides Update On The Status Of The Supplemental New Drug Application For Pitolisant In Idiopathic Hypersomnia

Harmony Biosciences: FDA Turns Away Idiopathic Hypersomnia Application

Harmony Biosciences : Needham Cuts Target Price to $50 From $52

THOMSON REUTERS

Harmony Biosciences Receives US FDA's Refusal to File Letter Related to Application for Pitolisant in Idiopathic Hypersomnia

MT Newswires Live

Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia

THOMSON REUTERS

Harmony Biosciences Holdings Inc - Receives FDA Refusal to File Letter for Pitolisant

THOMSON REUTERS

Harmony Biosciences -on Track to Initiate a Phase 3 Registrational Trial of Pitolisant Hd in Ih in Q4 2025, With a Target Pdufa Date in 2028

THOMSON REUTERS

Harmony Biosciences Holdings Inc - 2025 Net Revenue Guidance Remains Unchanged at $820-$860 Million

THOMSON REUTERS

Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia

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An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Since a changing earnings picture is a powerful factor influencing near-term stock price movements, the Zacks rating system is very useful for individual investors. They may find it difficult to make decisions based on rating upgrades by Wall Street analysts, as these are mostly driven by subjective factors that are hard to see and measure in real time.Therefore, the Zacks rating upgrade for Harmony Biosciences basically reflects positivity about its earnings outlook that could tr","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/harmony-biosciences-hrmy-upgraded-strong-170010269.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["HRMY"],"gpt_icon":0},{"id":"2513247447","title":"5 High Earnings Yield Value Stocks to Buy Amid Market Volatility","url":"https://stock-news.laohu8.com/highlight/detail?id=2513247447","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513247447?lang=en_us&edition=fundamental","pubTime":"2025-02-24 21:06","pubTimestamp":1740402360,"startTime":"0","endTime":"0","summary":"The U.S. stock market took a hit on Friday as a wave of troubling economic news sent all major indexes tumbling. 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Biosciences Holdings Inc  expected to post earnings of 74 cents a share - Earnings Preview","url":"https://stock-news.laohu8.com/highlight/detail?id=2513953252","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513953252?lang=en_us&edition=fundamental","pubTime":"2025-02-21 22:24","pubTimestamp":1740147861,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings Inc  expected to post earnings of74cents a share - Earnings Preview Harmony Biosciences Holdings Inc HRMY.OQ HRMY.O is expected to show a rise in quarterly revenue when 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20:01","pubTimestamp":1740052861,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250220:nAQN2K2SPK:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2512414940","title":"Concerns Over Harmony Biosciences: FDA Setback, Patent Risks, and High-Risk Pipeline","url":"https://stock-news.laohu8.com/highlight/detail?id=2512414940","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512414940?lang=en_us&edition=fundamental","pubTime":"2025-02-20 17:45","pubTimestamp":1740044742,"startTime":"0","endTime":"0","summary":"Analyst Jason Gerberry from Bank of America Securities reiterated a Sell rating on Harmony Biosciences Holdings (HRMY – Research Report) and decrea...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/concerns-over-harmony-biosciences-fda-setback-patent-risks-and-high-risk-pipeline?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/ratings/concerns-over-harmony-biosciences-fda-setback-patent-risks-and-high-risk-pipeline?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU1718418525.SGD","LU0130103400.USD","LU1363072403.SGD","LU1074936037.SGD","IE00B19Z3581.USD","LU1496350502.SGD","LU0648001328.SGD","LU0106831901.USD","LU0640476718.USD","LU0052756011.USD","LU0256863811.USD","LU0477156797.USD","LU0306806265.USD","LU0053666078.USD","IE00BLSP4452.SGD","LU2129689605.HKD","LU0648000940.SGD","BK4534","LU0320765489.SGD","LU1496350171.SGD","BK4007","LU2129689431.USD","IE00BZ1G4Q59.USD","IE00BBT3K403.USD","LU0310800965.SGD","LU0170899867.USD","LU2133065610.SGD","LU1880398471.USD","BK4504","BK4553","BAC","BK4559","LU1791807156.HKD","LU0234572021.USD","LU1883839398.USD","IE00B1BXHZ80.USD","HRMY","LU1894683348.USD","LU1668664300.SGD","BK4207","LU1280957306.USD","LU0128525689.USD","LU0320765646.SGD","BK4581","LU2129689514.USD","LU0130102774.USD","LU0321505868.SGD","IE00BKVL7J92.USD","IE0002270589.USD","IE00B19Z3B42.SGD"],"gpt_icon":0},{"id":"2512439602","title":"Harmony Biosciences Stock Falls On FDA Setback For Pitolisant In Sleeping Disorder","url":"https://stock-news.laohu8.com/highlight/detail?id=2512439602","media":"Benzinga","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512439602?lang=en_us&edition=fundamental","pubTime":"2025-02-20 03:24","pubTimestamp":1739993040,"startTime":"0","endTime":"0","summary":"On Wednesday, Harmony Biosciences Holdings, Inc.  received a Refusal to File  letter from the U.S. Food and Drug Administration  for pitolisant for excessive daytime sleepiness  in adult patients with idiopathic hypersomnia .Harmony’s 2025 net revenue guidance of $820 million-$860 million remains unchanged.Also Read: Neurology-Focused Harmony Biosciences Gains Confidence With Wakix Sales Surge, Strategic Pipeline Expansion, Bullish Analyst Says. Although the primary outcome for excessive daytime sleepiness  between pitolisant and placebo did not reach statistical significance in the randomized withdrawal phase of the Phase 3 INTUNE Study, the data from the open-label phase showed that patients experienced improvements on the Epworth Sleepiness Scale that were five times greater than what is recognized as clinically meaningful.Pitolisant is marketed as Wakixin the U.S. for EDS or cataplexy in adult patients with narcolepsy and for EDS in pediatric patients 6 years of age and older with ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/harmony-biosciences-stock-falls-fda-192400581.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4510","HRMY","BK4007","BK4563","BK4085","IH"],"gpt_icon":0},{"id":"2512480606","title":"Harmony Biosciences Price Target Maintained With a $75.00/Share by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2512480606","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512480606?lang=en_us&edition=fundamental","pubTime":"2025-02-20 01:36","pubTimestamp":1739986560,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/HRMY/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 19, 2025 12:36 ET (17:36 GMT)","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY"],"gpt_icon":0},{"id":"2512482918","title":"Harmony Biosciences: Buy Rating Affirmed Despite FDA Setback, Strong Growth Potential in Pitolisant Franchise and Pipeline Opportunities","url":"https://stock-news.laohu8.com/highlight/detail?id=2512482918","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512482918?lang=en_us&edition=fundamental","pubTime":"2025-02-20 00:55","pubTimestamp":1739984111,"startTime":"0","endTime":"0","summary":"Analyst Patrick Trucchio from H.C. Wainwright reiterated a Buy rating on Harmony Biosciences Holdings (HRMY – Research Report) and keeping the pric...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/harmony-biosciences-buy-rating-affirmed-despite-fda-setback-strong-growth-potential-in-pitolisant-franchise-and-pipeline-opportunities?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/ratings/harmony-biosciences-buy-rating-affirmed-despite-fda-setback-strong-growth-potential-in-pitolisant-franchise-and-pipeline-opportunities?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2512847044","title":"BUZZ-Harmony Biosciences drops after FDA refuses to review hypersomnia drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2512847044","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512847044?lang=en_us&edition=fundamental","pubTime":"2025-02-20 00:48","pubTimestamp":1739983695,"startTime":"0","endTime":"0","summary":"BUZZ-Harmony Biosciences drops after FDA refuses to review hypersomnia drug** Shares of rare neurological disease-focused pharma company Harmony Biosciences HRMY.O down 5.9% at $36.77**  Company says ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250219:nL3N3PA0ZR:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2512482197","title":"Harmony Biosciences Is Maintained at Buy by Needham","url":"https://stock-news.laohu8.com/highlight/detail?id=2512482197","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512482197?lang=en_us&edition=fundamental","pubTime":"2025-02-20 00:35","pubTimestamp":1739982900,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/HRMY/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 19, 2025 11:35 ET (16:35 GMT)","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY"],"gpt_icon":0},{"id":"2512585486","title":"BRIEF-Harmony Biosciences Provides Update On The Status Of The Supplemental New Drug Application For Pitolisant In Idiopathic Hypersomnia","url":"https://stock-news.laohu8.com/highlight/detail?id=2512585486","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512585486?lang=en_us&edition=fundamental","pubTime":"2025-02-19 23:22","pubTimestamp":1739978563,"startTime":"0","endTime":"0","summary":"BRIEF-Harmony Biosciences Provides Update On The Status Of The Supplemental New Drug Application For Pitolisant In Idiopathic HypersomniaFeb 19 (Reuters) - Harmony Biosciences Holdings Inc HRMY.O:HARM","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250219:nTUA35RXXV:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2512483201","title":"Harmony Biosciences: FDA Turns Away Idiopathic Hypersomnia Application","url":"https://stock-news.laohu8.com/highlight/detail?id=2512483201","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512483201?lang=en_us&edition=fundamental","pubTime":"2025-02-19 22:55","pubTimestamp":1739976900,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings said the Food and Drug Administration has turned away its application seeking expanded approval of its Wakix narcolepsy drug for the treatment of excessive daytime sleepiness in adults with the chronic sleep disorder idiopathic hypersomnia.Harmony on Wednesday said the FDA issued a \"refusal-to-file\" letter, which indicates that an application is incomplete and won't be reviewed.Harmony last year filed for the expanded approval of pitolisant, as Wakix is known generically, despite the drug missing its primary endpoint in a Phase 3 study in patients with idiopathic hypersomnia.The Plymouth Meeting, Pa., company termed the FDA's refusal to file a short-term setback and said its long-term strategy for pitolisant in idiopathic hypersomnia is on track with its focus on a higher-dose formulation of the drug.Harmony said it expects to launch a Phase 3 registrational study of pitolisant HD in the fourth quarter, with a target of FDA approval in idiopathic hypersomni","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":"Harmony Biosciences: FDA Turns Away Idiopathic Hypersomnia Application","news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2512044107","title":"Harmony Biosciences : Needham Cuts Target Price to $50 From $52","url":"https://stock-news.laohu8.com/highlight/detail?id=2512044107","media":"THOMSON 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Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512107639?lang=en_us&edition=fundamental","pubTime":"2025-02-19 21:50","pubTimestamp":1739973031,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings  said Wednesday that the US Food and Drug Administration issued a Refusal to File letter related to its supplemental new drug application for pitolisant in adults with idiopathic hypersomnia, a rare disorder characterized by excessive daytime sleepiness.The company said it continues to expect 2025 revenue of $820 million to $860 million.Analysts polled by FactSet expect $848.5 million.Harmony said it plans to start a phase 3 trial in Q4 for pitolisant HD, a higher-dose version, targeting a 2028 regulatory decision.The study design follows FDA input and builds on findings from the phase 3 INTUNE trial, the company said, adding that while the trial did not achieve \"statistical significance\" in its primary endpoint, patients in an open-label phase showed improvements in sleepiness scores.Shares of the company were down more than 7% in recent Wednesday premarket activity.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4007","HRMY"],"gpt_icon":0},{"id":"2512775101","title":"Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia","url":"https://stock-news.laohu8.com/highlight/detail?id=2512775101","media":"THOMSON 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2028","url":"https://stock-news.laohu8.com/highlight/detail?id=2512101092","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512101092?lang=en_us&edition=fundamental","pubTime":"2025-02-19 21:05","pubTimestamp":1739970300,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250219:nTUA35RXXV:5","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2512101013","title":"Harmony Biosciences Holdings Inc - 2025 Net Revenue Guidance Remains Unchanged at $820-$860 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Hypersomnia","url":"https://stock-news.laohu8.com/highlight/detail?id=2512710402","media":"Business Wire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512710402?lang=en_us&edition=fundamental","pubTime":"2025-02-19 21:05","pubTimestamp":1739970300,"startTime":"0","endTime":"0","summary":"PLYMOUTH MEETING, Pa., February 19, 2025----Harmony Biosciences Holdings, Inc.  today announced that it received a Refusal to File  letter from the U.S. Food and Drug Administration  for pitolisant for the treatment of excessive daytime sleepiness  in adult patients with idiopathic hypersomnia . Harmony’s 2025 net revenue guidance of $820-$860 million remains unchanged.\"Our planned Phase 3 registrational trial, a double-blind, randomized, parallel-group study in patients with IH, is based on input from the FDA,\" said Kumar Budur, M.D., M.S., Chief Medical and Scientific Officer at Harmony Biosciences. \"We believe this study design will effectively demonstrate the benefit of pitolisant in patients with IH based on the robust clinical response that was observed in the Phase 3 INTUNE Study. We are grateful to the patients and clinicians who participated in the INTUNE Study, and our commitment to these patients remains steadfast. 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