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Harmony Biosciences Holdings, Inc.

29.44

+0.08000.27%

Pre-market: 29.990.5500+1.87%04:46 EDT

Volume:415.04K

Turnover:12.23M

Market Cap:1.69B

PE:11.73

High:29.71

Open:29.44

Low:28.92

Close:29.36

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Overview Company News Filings

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

Press Release: Harmony Biosciences to Report Fourth Quarter and Full Year 2024 Financial Results on February 25, 2025

HRMY or ONC: Which Is the Better Value Stock Right Now?

Here is Why Growth Investors Should Buy Harmony Biosciences (HRMY) Now

Harmony Biosciences Holdings, Inc (HRMY): A Cheap Biotech Stock to Invest In Now

Deutsche Bank Initiates Coverage on Harmony Biosciences With Buy Rating, $55 Price Target

MT Newswires Live

Harmony Biosciences initiated with a Buy at Deutsche Bank

Insmed's NDA for Lung Disease Drug Gets FDA's Priority Review

RZLT Shares Rise 30.8% in 6 Months: What's Driving the Rally?

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Wainwright reiterated a Buy rating on Harmony Biosciences Holdings (HRMY – Research Report) and keeping the 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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 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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":"sh","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":"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":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["HRMY","BK4007"],"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 REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512775101?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: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":"2512101097","title":"Harmony Biosciences Holdings Inc - Receives FDA Refusal to File Letter for Pitolisant","url":"https://stock-news.laohu8.com/highlight/detail?id=2512101097","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512101097?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:4","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":"2512101092","title":"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","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 Million","url":"https://stock-news.laohu8.com/highlight/detail?id=2512101013","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512101013?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:2","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":"2512710402","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=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. With the initiation of this pivotal Phase 3 trial in Q4 2025","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-provides-status-supplemental-130500832.html","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":"yahoofinance","symbols":["IH","BK4085","BK4563","BK4510","BK4007","HRMY"],"gpt_icon":0},{"id":"2512529811","title":"Press Release: Harmony Biosciences to Report Fourth Quarter and Full Year 2024 Financial Results on February 25, 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2512529811","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512529811?lang=en_us&edition=fundamental","pubTime":"2025-02-18 21:05","pubTimestamp":1739883900,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings, Inc.  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  or 785-424-1699 , and reference passcode HRMYQ424. It is recommended that you dial in at least 10 minutes prior to the call.","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HRMY"],"gpt_icon":0},{"id":"2512992203","title":"HRMY or ONC: Which Is the Better Value Stock Right Now?","url":"https://stock-news.laohu8.com/highlight/detail?id=2512992203","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512992203?lang=en_us&edition=fundamental","pubTime":"2025-02-18 00:40","pubTimestamp":1739810413,"startTime":"0","endTime":"0","summary":"Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both Harmony Biosciences Holdings, Inc.  and BeiGene, Ltd. . But which of these two stocks is more attractive to value investors?We'll need to take a closer look to find out.The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank is a proven strategy that targets companies with positive earnings estimate revision trends, while our Style Scores work to grade companies based on specific traits.Harmony Biosciences Holdings, Inc. has a Zacks Rank of #1 , while BeiGene, Ltd. has a Zacks Rank of #3  right now. Investors should feel comfortable knowing that HRMY likely has seen a stronger improvement to its earnings outlook than ONC has recently. But this is only part of the picture for value investors.","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/hrmy-onc-better-value-stock-164013176.html","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":"yahoofinance","symbols":["BK4007","BK4139","ONC","HRMY"],"gpt_icon":0},{"id":"2511760695","title":"Here is Why Growth Investors Should Buy Harmony Biosciences (HRMY) Now","url":"https://stock-news.laohu8.com/highlight/detail?id=2511760695","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2511760695?lang=en_us&edition=fundamental","pubTime":"2025-02-14 01:45","pubTimestamp":1739468704,"startTime":"0","endTime":"0","summary":"Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a great growth stock is not easy at all.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Style Score , which looks beyond the traditional growth attributes to analyze a company's real growth prospects.Harmony Biosciences Holdings, Inc.  is one such stock that our proprietary system currently recommends. The company not only has a favorable Growth Score, but also carries a top Zacks Rank.Studies have shown that stocks with the best growth features consistently outperform the market. And returns are even better for stocks that possess the combination of a Growth Score of A or","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/why-growth-investors-buy-harmony-174504000.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","BK4007","BK4211","ISBC"],"gpt_icon":0},{"id":"2510521320","title":"Harmony Biosciences Holdings, Inc (HRMY): A Cheap Biotech Stock to Invest In Now","url":"https://stock-news.laohu8.com/highlight/detail?id=2510521320","media":"Insider Monkey","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510521320?lang=en_us&edition=fundamental","pubTime":"2025-02-12 19:17","pubTimestamp":1739359028,"startTime":"0","endTime":"0","summary":"We recently compiled a list of the 10 Cheap Biotech Stocks to Invest in Now.In this article, we are going to take a look at where Harmony Biosciences Holdings, Inc  stands against the other cheap biotech stocks.Biotech Stocks Face Uncertainty Despite Interest Rate Cuts. Biotechnology stocks are among the most volatile in the market due to their high risk. The outcomes of FDA clinical trials and the effectiveness of their therapies in the real world might cause significant fluctuations in their pricing. The introduction of COVID-19 vaccinations in 2020 caused the biotech industry to soar to prominence. As Big Pharma started investing in acquisitions, investor interest increased in late 2023 and early 2024. But the momentum faded, and for months, biotech stocks did not move. Few M&A transactions and initial public offerings  broke the otherwise quiet period in the second quarter, which saw a steep fall in biopharma deal activity. This slowdown followed a thriving first quarter in which p","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-holdings-inc-hrmy-111708917.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":["BK4159",".IXIC","CAGR","MNQmain","NVIW.SI","TSYW.SI","TQQQ","PSQ","USAW.SI","QID","BK4007","NQmain","QLD","HRMY","SQQQ","USJW.SI"],"gpt_icon":1},{"id":"2510800064","title":"Deutsche Bank Initiates Coverage on Harmony Biosciences With Buy Rating, $55 Price Target","url":"https://stock-news.laohu8.com/highlight/detail?id=2510800064","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510800064?lang=en_us&edition=fundamental","pubTime":"2025-02-11 20:18","pubTimestamp":1739276312,"startTime":"0","endTime":"0","summary":"Harmony Biosciences Holdings (HRMY) has an average rating of Buy and mean price target of $54.22, 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"],"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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["DB","HRMY"],"gpt_icon":0},{"id":"2510806008","title":"Harmony Biosciences initiated with a Buy at Deutsche Bank","url":"https://stock-news.laohu8.com/highlight/detail?id=2510806008","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510806008?lang=en_us&edition=fundamental","pubTime":"2025-02-11 18:25","pubTimestamp":1739269532,"startTime":"0","endTime":"0","summary":"Deutsche Bank analyst David Hoang initiated coverage of Harmony Biosciences (HRMY) with a Buy rating and $55 price target Published first on TheFly...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/harmony-biosciences-initiated-with-a-buy-at-deutsche-bank?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/the-fly/harmony-biosciences-initiated-with-a-buy-at-deutsche-bank?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BK4588","HRMY","BK4552","BK4118","BK4007","BK4566","BK4585","DB"],"gpt_icon":0},{"id":"2509747047","title":"Insmed's NDA for Lung Disease Drug Gets FDA's Priority Review","url":"https://stock-news.laohu8.com/highlight/detail?id=2509747047","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509747047?lang=en_us&edition=fundamental","pubTime":"2025-02-07 21:53","pubTimestamp":1738936380,"startTime":"0","endTime":"0","summary":"Insmed Incorporated INSM announced that the FDA has accepted its new drug application  seeking approval of its reversible inhibitor of dipeptidyl peptidase 1 , brensocatib, for treating patients with non-cystic fibrosis bronchiectasis.With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Aug. 12, 2025.If approved, brensocatib will become the first and only approved treatment for bronchiectasis, a chronic lung disease with no approved treatments. It would also become the first DPP1 inhibitor to be approved for the treatment of neutrophil-mediated diseases.Last month, the company outlined key pipeline goals for 2025. At the time, management stated that upon approval, it expects to launch brensocatib in the United States in the third quarter of 2025.In the past year, shares of Insmed have skyrocketed 182.7% against the industry’s decline of 6.5%.INSM's Brensocatib NDA Based on Data from ASPEN Study. The latest NDA was based on data from the","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/insmeds-nda-lung-disease-drug-135300938.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":["CSTL","ARGX","LU0320765992.SGD","BK4007","HRMY","LU0109394709.USD","BK4505","LU0889565916.HKD","BK4588","LU0053671581.USD","INSM","BK4139","BK4196","BK4585"],"gpt_icon":0},{"id":"2509209101","title":"RZLT Shares Rise 30.8% in 6 Months: What's Driving the Rally?","url":"https://stock-news.laohu8.com/highlight/detail?id=2509209101","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509209101?lang=en_us&edition=fundamental","pubTime":"2025-02-06 23:35","pubTimestamp":1738856100,"startTime":"0","endTime":"0","summary":"Shares of Rezolute RZLT have rallied 30.8% in the past six months against the industry’s decline of 4.1%, driven by investor enthusiasm about the company’s encouraging progress with the development activities for its lead pipeline candidate, ersodetug .Rezolute is a late-stage clinical biotech focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism .The company is evaluating ersodetug in the phase III sunRIZE study for treating patients with congenital HI, an ultra-rare pediatric genetic disorder.An independent Data Monitoring Committee  reviewed the OLA of the sunRIZE study, which evaluated ersodetug in eight infants aged between three months to one year for treating congenital HI. Per the DMC review, treatment with ersodetug was generally safe and well-tolerated in the given patient population. The DMC also approved the enrollment of subsequent infants into the double-blind portion of the study.Some better-ranked stocks in the biotech sector are 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