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Biocryst Pharmaceuticals

9.06

+0.27003.07%

Post-market: 9.05-0.0100-0.11%19:52 EDT

Volume:3.91M

Turnover:35.54M

Market Cap:1.90B

PE:-34.92

High:9.23

Open:8.91

Low:8.90

Close:8.79

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Overview Company News Filings

BioCryst Pharmaceuticals Faces FDA Review Extension for Pediatric ORLADEYO® Application, New Target Date Set for December 2025

BioCryst Pharmaceuticals Inc. Concluded Annual Stockholders Meeting

BioCryst announces new data on efficacy, safety of ORLADEYO

Sector Update: Health Care Stocks Lean Lower Premarket Friday

MT Newswires Live

BioCryst Pharmaceuticals Receives Approval for Orladeyo in Colombia

MT Newswires Live

BioCryst announces INVIMA in Colombia approved ORLADEYO

Orladeyo® (Berotralstat) Approved in Colombia

THOMSON REUTERS

Sector Update: Health Care Stocks Advance Premarket Friday

MT Newswires Live

Press Release: BioCryst Achieves Reimbursement for ORLADEYO Across all Major European Countries

BioCryst reports inducement grants under Nasdaq listing rule

BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

THOMSON REUTERS

BioCryst Says Orladeyo Prompted 'Significant' Drop Hereditary Angioedema Attacks in Study

MT Newswires Live

BioCryst Pharmaceuticals Says FDA Grants Priority Review for Orladeyo in Children

MT Newswires Live

BRIEF-Biocryst Announces FDA Acceptance Of NDA For Orladeyo (Berotralstat) Oral Granules In Patients With Hereditary Angioedema Aged 2 To 11 Years

BioCryst Gets Speedy FDA Review of Pediatric Use of Orladeyo

BioCryst Pharmaceuticals: Filed Line Extension Application for Use of Orladeyo Oral Granules in Patients With Hae Aged 2-11 Years With Ema

THOMSON REUTERS

BioCryst Pharmaceuticals Inc: FDA Grants Priority Review of Application, With Pdufa Target Action Date of September 12, 2025

THOMSON REUTERS

BioCryst Announces FDA Acceptance of Nda for Orladeyo® (Berotralstat) Oral Granules in Patients With Hereditary Angioedema Aged 2 to 11 Years

THOMSON REUTERS

BioCryst Pharmaceuticals Is Maintained at Equal-Weight by Barclays

Barclays Sticks to Its Hold Rating for BioCryst (BCRX)

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BioCryst Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration  has extended the Prescription Drug User Fee Act  goal date for the company's new drug application for ORLADEYO  oral granules. This extension pertains to the use of the medication in pediatric patients aged 2 to 11 years with hereditary angioedema . The FDA's decision to extend the deadline by three months, now set for December 12, 2025, follows the submission of additional final reports and formulation data by BioCryst, which were deemed a major amendment to the application. This extension allows the FDA ample time to conduct a thorough review of the new information.","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:20250625:nNDL9J7fgS:1","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":null,"symbols":["BK4139","BK4547","BCRX"],"gpt_icon":0},{"id":"2544988503","title":"BioCryst Pharmaceuticals Inc. Concluded Annual Stockholders Meeting","url":"https://stock-news.laohu8.com/highlight/detail?id=2544988503","media":"Reuters","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2544988503?lang=en_us&edition=fundamental","pubTime":"2025-06-17 04:14","pubTimestamp":1750104856,"startTime":"0","endTime":"0","summary":"BioCryst Pharmaceuticals Inc. held its Annual Meeting of Stockholders on June 12, 2025. During the meeting, several proposals were addressed. Two directors, Steven K. Galson, M.D., MPH, and Alan G. Levin, were elected to the board. The ratification of Ernst & Young LLP as the independent registered public accountants for 2025 was approved. Additionally, an amendment to the Stock Incentive Plan, which increased the number of shares available for issuance by 11,000,000 shares, was also approved.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. BioCryst Pharmaceuticals 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 ","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250616:nNDLs57wM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4547","BCRX","BK4139"],"gpt_icon":0},{"id":"2543712886","title":"BioCryst announces new data on efficacy, safety of ORLADEYO","url":"https://stock-news.laohu8.com/highlight/detail?id=2543712886","media":"TIPRANKS","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2543712886?lang=en_us&edition=fundamental","pubTime":"2025-06-16 19:15","pubTimestamp":1750072507,"startTime":"0","endTime":"0","summary":"BioCryst (BCRX) Pharmaceuticals announced new data on the long-term efficacy and safety of ORLADEYO for the prophylactic treatment of hereditary an...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/biocryst-announces-new-data-on-efficacy-safety-of-orladeyo-thefly?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/biocryst-announces-new-data-on-efficacy-safety-of-orladeyo-thefly?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":["BK4547","BCRX","BK4139"],"gpt_icon":0},{"id":"2543687483","title":"Sector Update: Health Care Stocks Lean Lower Premarket Friday","url":"https://stock-news.laohu8.com/highlight/detail?id=2543687483","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2543687483?lang=en_us&edition=fundamental","pubTime":"2025-06-13 21:15","pubTimestamp":1749820521,"startTime":"0","endTime":"0","summary":"Health care stocks were leaning lower premarket Friday with the Health Care Select Sector SPDR Fund  declining by 0.6% and the iShares Biotechnology ETF  down 1.1% recently.Moderna  shares were down more than 2% even after the company said the US Food and Drug Administration has approved its mRESVIA vaccine to prevent lower respiratory tract disease caused by respiratory syncytial virus in individuals aged 18 to 59 years who are at increased risk for disease.BioCryst Pharmaceuticals  shares were nearly 1% higher after the company said Colombia's National Institute of Drug and Food Surveillance has approved Orladeyo to prevent hereditary angioedema attacks in patients at least 12 years old.Astria Therapeutics  shares were up nearly 4% after the company said initial results from its ongoing long-term open-label trial of navenibart in hereditary angioedema showed a significant reduction in monthly attack rates, supporting the potential for dosing schedules of every three or six months.","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://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":["XLV","BK4588","BK4532","BK4533","BK4547","BK4585","MRNA","BCRX","BK4581","BK4501","BK4139","BK4568","ATXS","BK4534","IBB","BK4548","BK4551"],"gpt_icon":1},{"id":"2543689468","title":"BioCryst Pharmaceuticals Receives Approval for Orladeyo in Colombia","url":"https://stock-news.laohu8.com/highlight/detail?id=2543689468","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2543689468?lang=en_us&edition=fundamental","pubTime":"2025-06-13 19:25","pubTimestamp":1749813950,"startTime":"0","endTime":"0","summary":"BioCryst Pharmaceuticals  said Friday that Colombia's National Institute of Drug and Food Surveillance has approved Orladeyo to prevent hereditary angioedema attacks in patients at least 12 years old.The company said it has an exclusive collaboration with Pint Pharma for Orladeyo in the pan-Latin America region, with Pint in charge of all marketing authorizations and commercialization in the region.Orladeyo has also been approved in Chile, Argentina, Brazil, Mexico and Peru, the company said.","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4547","BK4139","BCRX"],"gpt_icon":0},{"id":"2543468674","title":"BioCryst announces INVIMA in Colombia approved ORLADEYO","url":"https://stock-news.laohu8.com/highlight/detail?id=2543468674","media":"TIPRANKS","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2543468674?lang=en_us&edition=fundamental","pubTime":"2025-06-13 19:05","pubTimestamp":1749812712,"startTime":"0","endTime":"0","summary":"BioCryst (BCRX) Pharmaceuticals announced that the National Institute of Drug and Food Surveillance, INVIMA, in Colombia has granted approval for o...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/biocryst-announces-invima-in-colombia-approved-orladeyo-thefly?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/biocryst-announces-invima-in-colombia-approved-orladeyo-thefly?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BCRX","BK4547","BK4139"],"gpt_icon":0},{"id":"2543686495","title":"Orladeyo® (Berotralstat) Approved in Colombia","url":"https://stock-news.laohu8.com/highlight/detail?id=2543686495","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2543686495?lang=en_us&edition=fundamental","pubTime":"2025-06-13 19:00","pubTimestamp":1749812451,"startTime":"0","endTime":"0","summary":null,"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:20250613:nFWN3SG0B5:1","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":["BK4139","BK4547","BCRX"],"gpt_icon":0},{"id":"2541836868","title":"Sector Update: Health Care Stocks Advance Premarket Friday","url":"https://stock-news.laohu8.com/highlight/detail?id=2541836868","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2541836868?lang=en_us&edition=fundamental","pubTime":"2025-06-06 21:10","pubTimestamp":1749215418,"startTime":"0","endTime":"0","summary":"Health care stocks were advancing premarket Friday as the Health Care Select Sector SPDR Fund  was up 0.5% and the iShares Biotechnology ETF  was 0.6% higher recently.Novo Nordisk's  obesity and diabetes drug semaglutide has a \"very rare side effect\" whereby patients taking the drug could develop a condition that may cause loss of vision, the European Medicines Agency said. Novo Nordisk shares were more than 2% higher pre-bell.Arvinas  and Pfizer  submitted a new drug application to the US Food and Drug Administration for vepdegestrant as a treatment for patients with ESR1-mutated advanced or metastatic breast cancer. Arvinas shares were up more than 1% premarket.BioCryst Pharmaceuticals  shares were 0.7% higher after the company said its Orladeyo drug has been approved for reimbursement in the Netherlands for the routine prevention of hereditary angioedema attacks in patients aged 12 years and up.","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://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":["NVO.AU","BK4532","LU0154236417.USD","PFE.AU","LU0122379950.USD","LU0289739699.SGD","IE00BLSP4239.USD","LU0985481810.HKD","LU0058720904.USD","LU0225284248.USD","LU0225771236.USD","BK4534","BCRX","SGXZ57979304.SGD","BK4585","SG9999003800.SGD","LU0868494617.USD","IE00B19Z3581.USD","LU1023059063.AUD","BK4588","IBB","LU1057294990.SGD","SG9999011175.SGD","BK4139","ARVN","BK4547","XLV","LU1093756325.SGD","LU0234572021.USD","BK7095","LU1894683348.USD","LU1066053197.SGD","IE00B19Z3B42.SGD","LU0321505439.SGD","IE00BZ1G4Q59.USD","IE0002270589.USD","LU1883839398.USD","BK7104","SG9999013999.USD","LU0306807586.USD","LU1093756168.USD","LU1066051498.USD","LU0306806265.USD","BK4533","IE00BLSP4452.SGD","LU0456855351.SGD","LU1894683264.USD","IE00BBT3K403.USD"],"gpt_icon":1},{"id":"2541851924","title":"Press Release: BioCryst Achieves Reimbursement for ORLADEYO Across all Major European Countries","url":"https://stock-news.laohu8.com/highlight/detail?id=2541851924","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2541851924?lang=en_us&edition=fundamental","pubTime":"2025-06-06 19:00","pubTimestamp":1749207600,"startTime":"0","endTime":"0","summary":"RESEARCH TRIANGLE PARK, N.C., June 06, 2025  -- BioCryst Pharmaceuticals, Inc.  today announced that, following a positive recommendation from the Zorginstituut Nederland, ORLADEYO  has been approved for the routine prevention of hereditary angioedema  attacks in patients aged 12 years and older. This reimbursement approval in the Netherlands marks national reimbursement for ORLADEYO across all major European countries, providing HAE patients with access to the first oral, once-daily preventive therapy.\"From day one, our mission has been to bring ORLADEYO to as many people living with hereditary angioedema as possible. Securing reimbursement in the Netherlands is a proud moment for our team as it means that patients and physicians across all major European countries now have access to a modern, oral prophylactic option to help prevent HAE attacks. This is a great day for the HAE community and for the future of treatment,\" said Abid Karim, general manager of Europe at BioCryst.This deci","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://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":["BCRX","R","BK4139","BK4232","LU0012050646.USD","LU0106261612.USD","LU0205194284.USD","IE00B64QTZ34.USD","LU1169590202.USD","BK4022","LU0205193047.USD","LU1169589451.USD","HAE","IE00BLDYK493.USD","BK4547","BK4198"],"gpt_icon":0},{"id":"2540821776","title":"BioCryst reports inducement grants under Nasdaq listing rule","url":"https://stock-news.laohu8.com/highlight/detail?id=2540821776","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2540821776?lang=en_us&edition=fundamental","pubTime":"2025-06-03 19:15","pubTimestamp":1748949333,"startTime":"0","endTime":"0","summary":"BioCryst (BCRX) Pharmaceuticals announced that the compensation committee of BioCryst’s board of directors granted seven newly-hired employees rest...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/biocryst-reports-inducement-grants-under-nasdaq-listing-rule-thefly?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/biocryst-reports-inducement-grants-under-nasdaq-listing-rule-thefly?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":["NDAQ","USJW.SI","LU2210150020.SGD","BK4112","TQQQ","BCRX","MNQmain","IE00B3QW5Z07.USD",".IXIC","BK4139","SQQQ","LU2210149790.SGD","IE00BGHQF748.EUR","NVIW.SI","QID","BK4547","IE00B64PRP62.GBP","TSYW.SI","BK4588","QLD","USAW.SI","NQmain","BK4585","LU2095319765.USD","IE00BKPKM429.USD","PSQ"],"gpt_icon":0},{"id":"2540775673","title":"BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)","url":"https://stock-news.laohu8.com/highlight/detail?id=2540775673","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2540775673?lang=en_us&edition=fundamental","pubTime":"2025-06-03 19:00","pubTimestamp":1748948456,"startTime":"0","endTime":"0","summary":null,"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:20250603:nTUAXBGRY: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":["BK4547","BCRX","BK4139"],"gpt_icon":0},{"id":"2535941423","title":"BioCryst Says Orladeyo Prompted 'Significant' Drop Hereditary Angioedema Attacks in Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2535941423","media":"MT Newswires Live","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535941423?lang=en_us&edition=fundamental","pubTime":"2025-05-16 20:17","pubTimestamp":1747397820,"startTime":"0","endTime":"0","summary":"BioCryst Pharmaceuticals  said Friday that new data showed \"significant and sustained\" reductions in hereditary angioedema attack rates among adolescents and other patients treated with Orladeyo.The findings were based on retrospective analyses involving 155 US patients over 18 months, the company said.Patients with more than eight attacks monthly saw an average reduction of over six attacks per month after one year of treatment, according to the study.In adolescents aged 12 to 17, average monthly attack rates fell by 1.56 at 12 months and by 1.85 at 18 months compared to baseline, BioCryst said.BioCryst reported consistent reductions in attack frequency across all 90-day follow-up periods after Orladeyo initiation.Shares of the company were up over 1.4% in recent Friday premarket activity.","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://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BCRX","BK4547","BK4139"],"gpt_icon":0},{"id":"2535290970","title":"BioCryst Pharmaceuticals Says FDA Grants Priority Review for Orladeyo in Children","url":"https://stock-news.laohu8.com/highlight/detail?id=2535290970","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535290970?lang=en_us&edition=fundamental","pubTime":"2025-05-14 20:33","pubTimestamp":1747225997,"startTime":"0","endTime":"0","summary":"BioCryst Pharmaceuticals  said Wednesday that the US Food and Drug Administration has accepted and granted priority review to its new drug application for Orladeyo, or berotralstat, to treat hereditary angioedema in children 2 to 11 years old.The company said the FDA has set a target action date of Sept. 12.The application was supported by interim data from a clinical trial showing that Orladeyo was well-tolerated with consistent safety profile and led to a sustained reduction in attack rates in the target age group, according to BioCryst.BioCryst said it has also submitted a line extension application with the European Medicines Agency for the use of Orladeyo oral granules in hereditary angioedema patients aged 2 to 11. Additional filings in other markets, including Japan and Canada, are being planned, the company added.Orladeyo is currently approved for adults and pediatric patients 12 years and older in over 30 countries, including the US, the company said.","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":["BCRX","BK4547","BK4139"],"gpt_icon":0},{"id":"2535025551","title":"BRIEF-Biocryst Announces FDA Acceptance Of NDA For Orladeyo (Berotralstat) Oral Granules In Patients With Hereditary Angioedema Aged 2 To 11 Years","url":"https://stock-news.laohu8.com/highlight/detail?id=2535025551","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535025551?lang=en_us&edition=fundamental","pubTime":"2025-05-14 19:55","pubTimestamp":1747223758,"startTime":"0","endTime":"0","summary":"BRIEF-Biocryst Announces FDA Acceptance Of NDA For Orladeyo (Berotralstat) Oral Granules In Patients With Hereditary Angioedema Aged 2 To 11 YearsMay 14 (Reuters) - BioCryst Pharmaceuticals Inc BCRX.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:20250514:nTUAC8HS9H: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":["BCRX","BK4139","BK4547"],"gpt_icon":0},{"id":"2535284170","title":"BioCryst Gets Speedy FDA Review of Pediatric Use of Orladeyo","url":"https://stock-news.laohu8.com/highlight/detail?id=2535284170","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535284170?lang=en_us&edition=fundamental","pubTime":"2025-05-14 19:33","pubTimestamp":1747222380,"startTime":"0","endTime":"0","summary":"BioCryst Pharmaceuticals has won U.S. Food and Drug Administration priority review for an application seeking expanded approval of its Orladeyo hereditary-angioedema drug for children ages 2 through 11.BioCryst on Wednesday said an FDA green light would make Orladeyo the first targeted oral prophylactic therapy for children under the age of 12 with hereditary angioedema, a genetic disorder characterized by recurrent episodes of severe swelling.The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. BioCryst said the agency set a target action date of Sept. 12 for the application.The FDA approved Orladeyo in December 2020 to prevent hereditary-angioedema attacks in patients 12 and older.BioCryst, a Durham, NC., biotechnology company, earlier this month raised its 2025 global Orladeyo revenue forecast to $580 million to $600 million from a prior range of ","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":"1","news_top_title":"BioCryst Gets Speedy FDA Review of Pediatric Use of Orladeyo","news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","BCRX","BK4547"],"gpt_icon":0},{"id":"2535042977","title":"BioCryst Pharmaceuticals: Filed Line Extension Application for Use of Orladeyo Oral Granules in Patients With Hae Aged 2-11 Years With Ema","url":"https://stock-news.laohu8.com/highlight/detail?id=2535042977","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535042977?lang=en_us&edition=fundamental","pubTime":"2025-05-14 19:00","pubTimestamp":1747220401,"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:20250514:nTUAC8HS9H:3","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":["BK4547","BCRX","BK4139"],"gpt_icon":0},{"id":"2535042151","title":"BioCryst Pharmaceuticals Inc: FDA Grants Priority Review of Application, With Pdufa Target Action Date of September 12, 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2535042151","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535042151?lang=en_us&edition=fundamental","pubTime":"2025-05-14 19:00","pubTimestamp":1747220401,"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:20250514:nTUAC8HS9H: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":["BK4547","BK4139","BCRX"],"gpt_icon":0},{"id":"2535042119","title":"BioCryst Announces FDA Acceptance of Nda for Orladeyo® (Berotralstat) Oral Granules in Patients With Hereditary Angioedema Aged 2 to 11 Years","url":"https://stock-news.laohu8.com/highlight/detail?id=2535042119","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535042119?lang=en_us&edition=fundamental","pubTime":"2025-05-14 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21:00","pubTimestamp":1746622800,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/BCRX/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 07, 2025 09:00 ET (13:00 GMT)","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://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":["BK4139","BCRX","BK4547"],"gpt_icon":0},{"id":"2533622622","title":"Barclays Sticks to Its Hold Rating for BioCryst (BCRX)","url":"https://stock-news.laohu8.com/highlight/detail?id=2533622622","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2533622622?lang=en_us&edition=fundamental","pubTime":"2025-05-07 15:17","pubTimestamp":1746602279,"startTime":"0","endTime":"0","summary":"Barclays analyst Gena Wang maintained a Hold rating on BioCryst (BCRX – Research Report) today and set a price target of $11.00. Wang covers the 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