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Harmony Biosciences Holdings, Inc.

27.06

-0.5400-1.96%

Volume:29.03K

Turnover:784.80K

Market Cap:1.56B

PE:9.99

High:27.36

Open:27.36

Low:26.77

Close:27.60

52wk High:40.87

52wk Low:25.52

Shares:57.60M

Float Shares:44.56M

Volume Ratio:0.81

T/O Rate:0.07%

Dividend:- -

Dividend Rate:- -

EPS(TTM):2.71

EPS(LYR):2.71

ROE:20.75%

ROA:11.48%

PB:1.79

PE(LYR):9.99

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Overview Company News Filings

Harmony Biosciences CFO Sandip Kapadia Reports Disposal of Common Shares

Harmony Biosciences Reports Promising Phase 3 Data for EPX-100 in Dravet Syndrome

Harmony Biosciences (HRMY) Is Up 7.6% After GR Pitolisant Bioequivalence Win and Patent Runway Push

Simply Wall St.

Harmony Biosciences Unveils New Phase 3 ARGUS Trial Data on EPX-100 for Dravet Syndrome

Mizuho Raises Price Target on Harmony Biosciences Holdings to $46 From $39, Keeps Outperform Rating

MT Newswires Live

Harmony Biosciences : Mizuho Raises Target Price to $46 From $39

THOMSON REUTERS

Harmony Biosciences Holdings (HRMY) Is Up 6.8% After Positive Pitolisant Study Results Are Patent Hopes Justified?

Simply Wall St.

Harmony Biosciences CFO Sandip Kapadia Reports Sale of Common Shares

Positive Outlook on Harmony Biosciences Holdings: Promising Pipeline Developments and Revenue Growth Potential

BUZZ- Harmony Biosciences jumps as co announces positive results from sleep disorder drug study

Harmony Biosciences Price Target Maintained With a $42.00/Share by Needham

Promising Developments and Upcoming Catalysts Drive Buy Rating for Harmony Biosciences

Harmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results

MT Newswires Live

Harmony Biosciences Shares Rise 2% Premarket After Co Announces Positive Results From Sleep Disorder Drug Study

THOMSON REUTERS

Harmony Biosciences: New Drug Application to Be Submitted in Early 2026; Target Pdufa in Q1 2027

THOMSON REUTERS

Harmony Biosciences - No New Safety Issues Reported for Pitolisant Gr

THOMSON REUTERS

Harmony Biosciences: Utility Patent Applications Filed With Potential Exclusivity to 2044

THOMSON REUTERS

Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation

THOMSON REUTERS

Harmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation

BRIEF-Harmony Biosciences Announces Initiation Of First-In-Human Study With Potential Best-In-Class Orexin 2 Receptor Agonist (Bp1.15205) For Central Disorders Of Hypersomnolence

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Biosciences CFO Sandip Kapadia Reports Disposal of Common Shares","url":"https://stock-news.laohu8.com/highlight/detail?id=2590321725","media":"Reuters","labels":["shareholding","insiderTrades","express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2590321725?lang=en_us&edition=fundamental","pubTime":"2025-12-10 05:11","pubTimestamp":1765314665,"startTime":"0","endTime":"0","summary":"Sandip Kapadia, Chief Financial Officer of Harmony Biosciences Holdings Inc., reported a disposal of common shares of the company. The full filing can be accessed through the link below.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on December 09, 2025, and is solely responsible for the information contained therein.","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:20251209:nNDLc3gXMt:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":"Harmony Biosciences CFO Sandip Kapadia Reports Disposal of Common Shares","news_tag":"shareholding,insiderTrades,express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4007","HRMY"],"gpt_icon":0},{"id":"2589353622","title":"Harmony Biosciences Reports Promising Phase 3 Data for EPX-100 in Dravet Syndrome","url":"https://stock-news.laohu8.com/highlight/detail?id=2589353622","media":"Reuters","labels":["dataReport","express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2589353622?lang=en_us&edition=fundamental","pubTime":"2025-12-08 21:05","pubTimestamp":1765199125,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings Inc. has announced initial data from the open-label extension  of its ongoing Phase 3 ARGUS trial, which is evaluating EPX-100  for the treatment of Dravet syndrome. The data, to be presented at the 2025 American Epilepsy Society Annual Meeting in December, showed that participants with at least six months of exposure to EPX-100 experienced a median reduction of approximately 50% in countable motor seizure frequency per 28 days. Half of the participants achieved at least a 50% reduction in seizure frequency. EPX-100 was generally well-tolerated, with the most common adverse events being seizures, pyrexia, and upper respiratory tract infection. No significant gastrointestinal adverse events were reported. The ARGUS and LIGHTHOUSE trials for EPX-100 are ongoing, with topline data from ARGUS expected in 2026.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timel","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:20251208:nNDL76YTwB:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport,express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4007","HRMY"],"gpt_icon":0},{"id":"2589306859","title":"Harmony Biosciences (HRMY) Is Up 7.6% After GR Pitolisant Bioequivalence Win and Patent Runway Push","url":"https://stock-news.laohu8.com/highlight/detail?id=2589306859","media":"Simply Wall St.","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2589306859?lang=en_us&edition=fundamental","pubTime":"2025-12-05 08:23","pubTimestamp":1764894219,"startTime":"0","endTime":"0","summary":"Harmony Biosciences recently reported positive pivotal bioequivalence results for its gastro-resistant (GR) pitolisant formulation, confirming equivalence to existing WAKIX tablets and supporting plans to file a New Drug Application in early 2026 with a potential review decision in the first quarter of 2027.\nBy pairing these GR data with high-dose pitolisant development and patent applications that could extend exclusivity to 2044, Harmony is reinforcing the long-term durability of its...","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/6121000-choice2-main-header/1585186699299","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6121000-choice2-main-header/1585186699299"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-hrmy/harmony-biosciences-holdings/news/harmony-biosciences-hrmy-is-up-76-after-gr-pitolisant-bioequ","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-hrmy/harmony-biosciences-holdings/news/harmony-biosciences-hrmy-is-up-76-after-gr-pitolisant-bioequ","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"simplywall_highlight","symbols":["BK4007","HRMY"],"gpt_icon":0},{"id":"2588053716","title":"Harmony Biosciences Unveils New Phase 3 ARGUS Trial Data on EPX-100 for Dravet Syndrome","url":"https://stock-news.laohu8.com/highlight/detail?id=2588053716","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2588053716?lang=en_us&edition=fundamental","pubTime":"2025-12-02 21:05","pubTimestamp":1764680721,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings Inc. has announced that new open-label extension data from its ongoing Phase 3 ARGUS trial investigating EPX-100  for the treatment of Dravet syndrome will be presented at the 2025 American Epilepsy Society Annual Meeting. The meeting will take place from December 5 to December 9, 2025, in Atlanta, Georgia. Poster presentations are scheduled for Monday, December 8, with topics including preliminary results from the open-label extension phase of the ARGUS study and a drug-drug interaction study of EPX-100 with clinical probe substrates for selected CYP enzymes. The ARGUS trial is currently enrolling participants.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the o","market":"nz","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:20251202:nNDLb8fP9X:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2588372799","title":"Mizuho Raises Price Target on Harmony Biosciences Holdings to $46 From $39, Keeps Outperform Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2588372799","media":"MT Newswires Live","labels":["express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2588372799?lang=en_us&edition=fundamental","pubTime":"2025-12-01 20:43","pubTimestamp":1764592990,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings (HRMY) has an average rating of buy and mean price target of $46.18, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research f","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate","earning"],"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":"express","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["MFG","HRMY"],"gpt_icon":0},{"id":"2588217287","title":"Harmony Biosciences : Mizuho Raises Target Price to $46 From $39","url":"https://stock-news.laohu8.com/highlight/detail?id=2588217287","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2588217287?lang=en_us&edition=fundamental","pubTime":"2025-12-01 19:35","pubTimestamp":1764588928,"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:20251201:nFWN3X70H1:1","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":"2586279104","title":"Harmony Biosciences Holdings (HRMY) Is Up 6.8% After Positive Pitolisant Study Results Are Patent Hopes Justified?","url":"https://stock-news.laohu8.com/highlight/detail?id=2586279104","media":"Simply Wall St.","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2586279104?lang=en_us&edition=fundamental","pubTime":"2025-11-28 07:30","pubTimestamp":1764286208,"startTime":"0","endTime":"0","summary":"Earlier this week, Harmony Biosciences Holdings announced positive pivotal bioequivalence study results for its new pitolisant gastro-resistant formulation, setting the stage for a planned New Drug Application submission in early 2026.\nWith patent applications potentially extending pitolisant exclusivity to 2044, the company is aiming to reinforce its leadership position in sleep disorder therapeutics.\nWe'll explore how the bioequivalence study success and anticipated regulatory milestones...","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/6121000-choice2-main-header/1585186699299","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6121000-choice2-main-header/1585186699299"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-hrmy/harmony-biosciences-holdings/news/harmony-biosciences-holdings-hrmy-is-up-68-after-positive-pi","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-hrmy/harmony-biosciences-holdings/news/harmony-biosciences-holdings-hrmy-is-up-68-after-positive-pi","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"simplywall_highlight","symbols":["BK4007","HRMY"],"gpt_icon":0},{"id":"2586409644","title":"Harmony Biosciences CFO Sandip Kapadia Reports Sale of Common Shares","url":"https://stock-news.laohu8.com/highlight/detail?id=2586409644","media":"Reuters","labels":["shareholding","insiderTrades","express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2586409644?lang=en_us&edition=fundamental","pubTime":"2025-11-26 05:10","pubTimestamp":1764105042,"startTime":"0","endTime":"0","summary":"Sandip Kapadia, Chief Financial Officer of Harmony Biosciences Holdings Inc., reported a disposal of common shares of the company. The full filing can be accessed through the link below.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on November 25, 2025, and is solely responsible for the information contained therein.","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:20251125:nNDL3GFhKY:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":"Harmony Biosciences CFO Sandip Kapadia Reports Sale of Common Shares","news_tag":"shareholding,insiderTrades,express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2586549618","title":"Positive Outlook on Harmony Biosciences Holdings: Promising Pipeline Developments and Revenue Growth Potential","url":"https://stock-news.laohu8.com/highlight/detail?id=2586549618","media":"TIPRANKS","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2586549618?lang=en_us&edition=fundamental","pubTime":"2025-11-25 00:05","pubTimestamp":1764000341,"startTime":"0","endTime":"0","summary":"H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating on Harmony Biosciences Holdings today and set a price target of $55.00. Patrick Tr...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/positive-outlook-on-harmony-biosciences-holdings-promising-pipeline-developments-and-revenue-growth-potential-ratings?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/ratings/positive-outlook-on-harmony-biosciences-holdings-promising-pipeline-developments-and-revenue-growth-potential-ratings?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["HRMY"],"gpt_icon":0},{"id":"2585951484","title":"BUZZ- Harmony Biosciences jumps as co announces positive results from sleep disorder drug study","url":"https://stock-news.laohu8.com/highlight/detail?id=2585951484","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2585951484?lang=en_us&edition=fundamental","pubTime":"2025-11-24 23:43","pubTimestamp":1763998983,"startTime":"0","endTime":"0","summary":"BUZZ-Harmony Biosciences jumps as co announces positive results from sleep disorder drug study** Shares of Harmony Biosciences HRMY.O rise 2.2% to $35.07** Co reports positive results from key study on pitolisant GR, a gastro-resistant tablet formulation of its sleep disorder drug Wakix designed to withstand stomach acid and dissolve in the intestine** HRMY says results support plan to file for U.S. approval in early 2026; aims for FDA decision in Q1 2027** New GR tablets shown to work the same as current Wakix tablets; no new safety issues found** Study also showed all patients could start at full dose without gradual increase** HRMY stock up 0.5%% YTD, including session moves   ","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:20251124:nL6N3X00MM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2585493449","title":"Harmony Biosciences Price Target Maintained With a $42.00/Share by Needham","url":"https://stock-news.laohu8.com/highlight/detail?id=2585493449","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2585493449?lang=en_us&edition=fundamental","pubTime":"2025-11-24 23:13","pubTimestamp":1763997180,"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  November 24, 2025 10:13 ET (15:13 GMT)","market":"hk","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":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2585905498","title":"Promising Developments and Upcoming Catalysts Drive Buy Rating for Harmony Biosciences","url":"https://stock-news.laohu8.com/highlight/detail?id=2585905498","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2585905498?lang=en_us&edition=fundamental","pubTime":"2025-11-24 22:25","pubTimestamp":1763994330,"startTime":"0","endTime":"0","summary":"Analyst Ami Fadia of Needham reiterated a Buy rating on Harmony Biosciences Holdings, retaining the price target of $42.00. Ami Fadia has given his...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/promising-developments-and-upcoming-catalysts-drive-buy-rating-for-harmony-biosciences-ratings?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/promising-developments-and-upcoming-catalysts-drive-buy-rating-for-harmony-biosciences-ratings?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":"2585460695","title":"Harmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results","url":"https://stock-news.laohu8.com/highlight/detail?id=2585460695","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2585460695?lang=en_us&edition=fundamental","pubTime":"2025-11-24 22:08","pubTimestamp":1763993303,"startTime":"0","endTime":"0","summary":"Harmony Biosciences  said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix  to treat narcolepsy.The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.","market":"sg","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["HRMY","BK4007"],"gpt_icon":0},{"id":"2585467875","title":"Harmony Biosciences Shares Rise 2% Premarket After Co Announces Positive Results From Sleep Disorder Drug Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2585467875","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2585467875?lang=en_us&edition=fundamental","pubTime":"2025-11-24 21:28","pubTimestamp":1763990923,"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:20251124:nL4N3X00O8:1","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":["BK4007","HRMY"],"gpt_icon":0},{"id":"2585746299","title":"Harmony Biosciences: New Drug Application to Be Submitted in Early 2026; 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The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX  tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be inter","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:20251124:nNDL5wVlz2:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport,express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4007","HRMY"],"gpt_icon":0},{"id":"2584421909","title":"BRIEF-Harmony Biosciences Announces Initiation Of First-In-Human Study With Potential Best-In-Class Orexin 2 Receptor Agonist (Bp1.15205) For Central Disorders Of Hypersomnolence","url":"https://stock-news.laohu8.com/highlight/detail?id=2584421909","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2584421909?lang=en_us&edition=fundamental","pubTime":"2025-11-19 22:12","pubTimestamp":1763561552,"startTime":"0","endTime":"0","summary":"BRIEF-Harmony Biosciences Announces Initiation Of First-In-Human Study With Potential Best-In-Class Orexin 2 Receptor Agonist (Bp1.15205) For Central Disorders Of HypersomnolenceHarmony Biosciences Ho","market":"nz","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:20251119:nFWN3WV0R5:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY","BK4007"],"gpt_icon":0}],"pageSize":20,"totalPage":6,"pageCount":3,"totalSize":112,"code":"91000000","status":"200"}]}}