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Precigen

1.42

-0.0100-0.70%

Post-market: 1.460.0400+2.82%19:57 EDT

Volume:5.16M

Turnover:7.36M

Market Cap:419.16M

PE:-2.53

High:1.50

Open:1.43

Low:1.39

Close:1.43

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Overview Company News Filings

Buy Rating for Precigen Driven by Promising Developments and Strong Market Potential of PRGN-2012

Precigen Says FDA Accepts for Priority Review Application for Recurrent Respiratory Papillomatosis Treatment

MT Newswires Live

Precigen Shares Jump 21.1% After FDA Grants Priority Review Status for Its Respiratory Tract Disease Treatment

THOMSON REUTERS

Precigen Shares Rise 16.6% Premarket After FDA Grants Priority Review Status for Its Respiratory Tract Disease Treatment

THOMSON REUTERS

Precigen Gets FDA Priority Review of Recurrent Respiratory Papillomatosis Treatment

FDA Grants Priority Review to Precigen's Bla for Prgn-2012 for the Treatment of Adults With Recurrent Respiratory Papillomatosis With Pdufa Target Action Date Set for August 27, 2025

THOMSON REUTERS

FDA Grants Priority Review to Precigen's BLA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis with PDUFA Target Action Date Set for August 27, 2025

Precigen Price Target Raised to $6.00/Share From $4.00 by HC Wainwright & Co.

Precigen Price Target Maintained With a $5.00/Share by JMP Securities

Precigen’s Strategic Advancements and Pipeline Developments Drive Buy Rating

PGEN Stock Surges More Than 40% in a Week: What's Driving the Rally?

Exploring 3 Prominent High Growth Tech Stocks In The United States

Simply Wall St.

Precigen Secures $79M Financing for 2025 Launch

Stifel thinks Precigen stock set to rebound after capital secured, BLA submitted

Precigen’s Strategic Advances and Financial Strength Boost Market Position for PRGN-2012

Sector Update: Health Care Stocks Lean Lower Pre-Bell Monday

MT Newswires Live

Precigen Completes Submission of Biologics License Application for Respiratory Disease Treatment; Shares Jump Pre-Bell

MT Newswires Live

Precigen Completes Submission of Bla With Request for Priority Review to the FDA for Prgn-2012 for the Treatment of Adults With Recurrent Respiratory Papillomatosis

THOMSON REUTERS

Precigen Completes Submission of BLA with Request for Priority Review to the FDA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis

JMP Securities Adjusts Price Target on Precigen to $5 From $7, Keeps Market Outperform Rating

MT Newswires Live

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Rating for Precigen Driven by Promising Developments and Strong Market Potential of PRGN-2012","url":"https://stock-news.laohu8.com/highlight/detail?id=2514011839","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514011839?lang=en_us&edition=fundamental","pubTime":"2025-02-26 00:25","pubTimestamp":1740500714,"startTime":"0","endTime":"0","summary":"In a report released today, Jason Butler from JMP Securities reiterated a Buy rating on Precigen (PGEN – Research Report), with a price target of $...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/buy-rating-for-precigen-driven-by-promising-developments-and-strong-market-potential-of-prgn-2012?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/ratings/buy-rating-for-precigen-driven-by-promising-developments-and-strong-market-potential-of-prgn-2012?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":["PGEN"],"gpt_icon":0},{"id":"2514645018","title":"Precigen Says FDA Accepts for Priority Review Application for Recurrent Respiratory Papillomatosis Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2514645018","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514645018?lang=en_us&edition=fundamental","pubTime":"2025-02-25 22:56","pubTimestamp":1740495378,"startTime":"0","endTime":"0","summary":"Precigen  said Tuesday that a biologics license application for PRGN-2012, an investigational gene therapy for the treatment of adults with recurrent respiratory papillomatosis, was accepted by the US Food and Drug Administration for priority review.The agency set a target action date of Aug. 27 and said that it is not planning to hold an advisory committee meeting to discuss the application.PRGN-2012 is designed to elicit immune responses directed against cells infected with human papillomavirus 6 or HPV 11, the company said.The application is supported by data from a clinical study that met its primary safety and efficacy endpoints, Precigen said. The study showed more than 50% of patients achieving complete response and more than 85% of patients experiencing a decrease in surgical interventions in the year after treatment compared to the year prior to treatment.PGEN shares were over 2% higher in recent trading.Price: 1.79, Change: +0.03, Percent Change: +2.00","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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4139","PGEN"],"gpt_icon":0},{"id":"2514974850","title":"Precigen Shares Jump 21.1% After FDA Grants Priority Review Status for Its Respiratory Tract Disease 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Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2514496091","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514496091?lang=en_us&edition=fundamental","pubTime":"2025-02-25 21:34","pubTimestamp":1740490443,"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:20250225:nFWN3PG0KR: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","PGEN"],"gpt_icon":0},{"id":"2514259091","title":"Precigen Gets FDA Priority Review of Recurrent Respiratory Papillomatosis Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2514259091","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514259091?lang=en_us&edition=fundamental","pubTime":"2025-02-25 21:28","pubTimestamp":1740490080,"startTime":"0","endTime":"0","summary":"Precigen has won U.S. Food and Drug Administration priority review for its application seeking approval of its proposed PRGN-2012 gene therapy for adults with recurrent respiratory papillomatosis, a rare disorder of the vocal cords.Precigen on Tuesday said a green light would make PRGN-2012 the only FDA-approved therapeutic for the treatment of adults with the disorder, which is a lifelong neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11 that can be fatal.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.Precigen said the FDA set a target action date of Aug. 27, adding that the agency indicated that is isn't currently planning to hold an advisory committee meeting to discuss the application.The Germantown, Md., biopharmaceutical company said it hopes to introduce PRGN-2012 to the recurrent respir","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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","PGEN"],"gpt_icon":0},{"id":"2514099815","title":"FDA Grants Priority Review to Precigen's Bla for Prgn-2012 for the Treatment of Adults With Recurrent Respiratory Papillomatosis With Pdufa Target Action Date Set for August 27, 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2514099815","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514099815?lang=en_us&edition=fundamental","pubTime":"2025-02-25 21:05","pubTimestamp":1740488703,"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:20250225:nTUA9QLVYW: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":["PGEN","BK4139"],"gpt_icon":0},{"id":"2514913550","title":"FDA Grants Priority Review to Precigen's BLA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis with PDUFA Target Action Date Set for August 27, 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2514913550","media":"PR Newswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514913550?lang=en_us&edition=fundamental","pubTime":"2025-02-25 21:05","pubTimestamp":1740488700,"startTime":"0","endTime":"0","summary":"– Priority review reduces the BLA review timeline to 6-months and is granted to therapies that, if approved, would provide significant improvements in the treatment, diagnosis or prevention of serious conditions –。– If approved, PRGN-2012 would be the first and only available FDA-approved therapy for eligible patients with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries –。The BLA is supported by data from the pivotal Phase 1/2 clinical study , which were presented at the 2024 American Society of Clinical Oncology  annual meeting and published in The Lancet Respiratory Medicine. The pivotal studymet its primary safety and efficacy endpoints, with more than 50% of patients achieving Complete Response and more than 85% of patients experiencing a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment. PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatme","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/fda-grants-priority-review-precigens-130500478.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/fda-grants-priority-review-precigens-130500478.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":["PGEN","BK4139"],"gpt_icon":0},{"id":"2505092055","title":"Precigen Price Target Raised to $6.00/Share From $4.00 by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2505092055","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2505092055?lang=en_us&edition=fundamental","pubTime":"2025-01-23 20:22","pubTimestamp":1737634920,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/PGEN/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  January 23, 2025 07:22 ET (12:22 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":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["PGEN"],"gpt_icon":0},{"id":"2503457193","title":"Precigen Price Target Maintained With a $5.00/Share by JMP Securities","url":"https://stock-news.laohu8.com/highlight/detail?id=2503457193","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2503457193?lang=en_us&edition=fundamental","pubTime":"2025-01-14 22:45","pubTimestamp":1736865900,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/PGEN/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  January 14, 2025 09:45 ET (14:45 GMT)","market":"fut","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":["PGEN","JMP"],"gpt_icon":0},{"id":"2503557256","title":"Precigen’s Strategic Advancements and Pipeline Developments Drive Buy Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2503557256","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2503557256?lang=en_us&edition=fundamental","pubTime":"2025-01-14 07:25","pubTimestamp":1736810710,"startTime":"0","endTime":"0","summary":"Analyst Jason Butler from JMP Securities reiterated a Buy rating on Precigen (PGEN – Research Report) and keeping the price target at $5.00. Jason ...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/precigens-strategic-advancements-and-pipeline-developments-drive-buy-rating?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/precigens-strategic-advancements-and-pipeline-developments-drive-buy-rating?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":["PGEN"],"gpt_icon":0},{"id":"2500902522","title":"PGEN Stock Surges More Than 40% in a Week: What's Driving the Rally?","url":"https://stock-news.laohu8.com/highlight/detail?id=2500902522","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500902522?lang=en_us&edition=fundamental","pubTime":"2025-01-03 02:28","pubTimestamp":1735842480,"startTime":"0","endTime":"0","summary":"Shares of Precigen PGEN have soared nearly 43% in the past week after the company provided an encouraging regulatory update for its lead pipeline program.Last week, Precigen announced that it has completed a rolling submission for a biologic license application  seeking the FDA’s accelerated approval for PRGN-2012, an experimental gene therapy to treat adults with recurrent respiratory papillomatosis .A rare disease, RRP causes benign tumors  to grow in the respiratory tract, most commonly in the larynx . It is caused by two types of human papilloma virus  – HPV 6 and HPV 11.The BLA is supported by data from a pivotal phase I/II study that evaluated PRGN-2012 for the treatment of adult patients with RRP. Data from the study showed that more than 50% of patients achieved a complete response . Also, more than 85% of patients experienced a reduction in surgical interventions in the year after receiving PRGN-2012 compared to the year before receiving the therapy.Precigen currently carries ","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/pgen-stock-surges-more-40-182800609.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":["BK4568","BK4139","BK4196","CTMX","CSTL","BK4583","INO","PGEN"],"gpt_icon":0},{"id":"2500832938","title":"Exploring 3 Prominent High Growth Tech Stocks In The United States","url":"https://stock-news.laohu8.com/highlight/detail?id=2500832938","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500832938?lang=en_us&edition=fundamental","pubTime":"2025-01-01 22:02","pubTimestamp":1735740172,"startTime":"0","endTime":"0","summary":"Over the last 7 days, the United States market has dropped 2.6%, yet it remains up by 23% over the past year with earnings anticipated to grow by 15% annually in the coming years. In this context, identifying high growth tech stocks involves looking for companies with strong innovation potential and robust financial health that can thrive even amidst short-term market fluctuations.Top 10 High Growth Tech Companies In The United States. Overview: GoodRx Holdings, Inc. provides consumers in the United States with tools and information to compare prices and save on prescription drug purchases, with a market cap of approximately $1.74 billion.Overview: Halozyme Therapeutics, Inc. is a biopharma technology platform company that focuses on researching, developing, and commercializing proprietary enzymes and devices globally, with a market cap of approximately $6.11 billion.","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/exploring-3-prominent-high-growth-140252952.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":["BK4167","GDRX","PGEN","BK4211","HALO","UBCP"],"gpt_icon":0},{"id":"2495506926","title":"Precigen Secures $79M Financing for 2025 Launch","url":"https://stock-news.laohu8.com/highlight/detail?id=2495506926","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495506926?lang=en_us&edition=fundamental","pubTime":"2024-12-31 05:48","pubTimestamp":1735595289,"startTime":"0","endTime":"0","summary":"Precigen ( ($PGEN) ) has provided an announcement. Precigen has announced a private placement of $79.0 million through the sale of its 8.00% Series...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/company-announcements/precigen-secures-79m-financing-for-2025-launch?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/company-announcements/precigen-secures-79m-financing-for-2025-launch?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":["PGEN","BK4139"],"gpt_icon":0},{"id":"2495525626","title":"Stifel thinks Precigen stock set to rebound after capital secured, BLA submitted","url":"https://stock-news.laohu8.com/highlight/detail?id=2495525626","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495525626?lang=en_us&edition=fundamental","pubTime":"2024-12-30 22:45","pubTimestamp":1735569942,"startTime":"0","endTime":"0","summary":"Stifel notes Precigen (PGEN) has completed the BLA submission of PRGN-2012, which comes on the heels of 2 financial announcements that together pro...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/stifel-thinks-precigen-stock-set-to-rebound-after-capital-secured-bla-submitted?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/stifel-thinks-precigen-stock-set-to-rebound-after-capital-secured-bla-submitted?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":["SF","PGEN","BK4127","BK4139"],"gpt_icon":0},{"id":"2495485525","title":"Precigen’s Strategic Advances and Financial Strength Boost Market Position for PRGN-2012","url":"https://stock-news.laohu8.com/highlight/detail?id=2495485525","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495485525?lang=en_us&edition=fundamental","pubTime":"2024-12-30 22:45","pubTimestamp":1735569911,"startTime":"0","endTime":"0","summary":"Stifel Nicolaus analyst Benjamin Burnett has maintained their bullish stance on PGEN stock, giving a Buy rating today. Benjamin Burnett’s rating is...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/precigens-strategic-advances-and-financial-strength-boost-market-position-for-prgn-2012?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/blurbs/precigens-strategic-advances-and-financial-strength-boost-market-position-for-prgn-2012?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":["BK4139","PGEN"],"gpt_icon":0},{"id":"2495998540","title":"Sector Update: Health Care Stocks Lean Lower Pre-Bell Monday","url":"https://stock-news.laohu8.com/highlight/detail?id=2495998540","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495998540?lang=en_us&edition=fundamental","pubTime":"2024-12-30 22:09","pubTimestamp":1735567798,"startTime":"0","endTime":"0","summary":"Health care stocks were leaning lower premarket Monday as the Health Care Select Sector SPDR Fund  was down 0.7% and the iShares Biotechnology ETF  was inactive.Marinus Pharmaceuticals  soared 43% after it said it signed a deal under which Immedica Pharma will acquire all of its issued and outstanding shares for $0.55 a share.Axsome Therapeutics  said Monday it has met the primary endpoint in its ACCORD-2 phase 3 trial of AXS-05, which is intended for Alzheimer's disease agitation, but failed to achieve statistical significance for its primary endpoint in another trial. Axsome shares slid 7.1%.Precigen  said Monday it has completed a rolling biologics license application submission to the US Food and Drug Administration for PRGN-2012, a treatment for recurrent respiratory papillomatosis in adults. Precigen shares rose 12.8%.","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":["BK4581","BK4588","PGEN","BK4585","MRNS","BK4505","XLV","BK4139","IBB","AXSM","BK4007"],"gpt_icon":0},{"id":"2495460735","title":"Precigen Completes Submission of Biologics License Application for Respiratory Disease Treatment; Shares Jump Pre-Bell","url":"https://stock-news.laohu8.com/highlight/detail?id=2495460735","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495460735?lang=en_us&edition=fundamental","pubTime":"2024-12-30 20:35","pubTimestamp":1735562155,"startTime":"0","endTime":"0","summary":"Precigen  said Monday it has completed a rolling biologics license application submission to the US Food and Drug Administration for PRGN-2012, a treatment for recurrent respiratory papillomatosis in adults.The FDA is reviewing the submission to determine acceptance and to set a Prescription Drug User Fee Act action date, the company said.Precigen said it has requested a priority review, which would shorten the review period to six months, the company said.Precigen shares were more than 18% higher in premarket trading.","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["PGEN","BK4139"],"gpt_icon":0},{"id":"2495543767","title":"Precigen Completes Submission of Bla With Request for Priority Review to the FDA for Prgn-2012 for the Treatment of Adults With Recurrent Respiratory Papillomatosis","url":"https://stock-news.laohu8.com/highlight/detail?id=2495543767","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495543767?lang=en_us&edition=fundamental","pubTime":"2024-12-30 20:00","pubTimestamp":1735560002,"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:20241230:nTUA8FCJX8:1","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":["PGEN","BK4139"],"gpt_icon":0},{"id":"2495545521","title":"Precigen Completes Submission of BLA with Request for Priority Review to the FDA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis","url":"https://stock-news.laohu8.com/highlight/detail?id=2495545521","media":"PR Newswire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2495545521?lang=en_us&edition=fundamental","pubTime":"2024-12-30 20:00","pubTimestamp":1735560000,"startTime":"0","endTime":"0","summary":"– PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of adults with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries – – PRGN-2012 received Breakthrough Therapy Designation from the FDA and Orphan Drug Designation from the FDA and the European Commission –– The BLA, under an accelerated approval pathway, is supported by data from the Phase 1/2 pivotal study in which more than 50% of patients achieved Complete Response and more than 85% of patients had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment –– PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 –。PRGN-2012 is an investigational AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus  6 or HPV 11. PRGN-2012 received Breakthrough Therapy Desig","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/precigen-completes-submission-bla-request-120000584.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/precigen-completes-submission-bla-request-120000584.html","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":"yahoofinance","symbols":["BK4139","BK4218","BK4181","INN","PGEN"],"gpt_icon":0},{"id":"2495111315","title":"JMP Securities Adjusts Price Target on Precigen to $5 From $7, Keeps Market Outperform 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