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Super League Gaming Inc.

0.2524

+0.01546.50%

Post-market: 0.2406-0.0118-4.68%16:00 EDT

Volume:46.97K

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Market Cap:4.49M

PE:-0.11

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Fate Therapeutics' Lupus Candidate FT819 Gets FDA RMAT Tag

Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE)

Press Release: Artiva Biotherapeutics Appoints Subhashis Banerjee, M.D., as Chief Medical Officer

FDA Grants Three Fast Track Tags to Allogene's Autoimmune Disease Drug

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It opens up early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application.FT819 is an off-the-shelf, iPSC-derived CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.The latest RMAT designation by the FDA underlines the potential of FT819 to address an area of significant unmet medical needs.Year to date, shares of Fate Therapeutics have plunged 44% comp","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/fate-therapeutics-lupus-candidate-ft819-144200510.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":["BK4139","LU0823416689.USD","ADMA","BK4077","BK4533","JAZZ","IE00BN0W2W23.USD","KRYS","FATE","BK4007","IE00BN0W2V16.EUR","LU0320765992.SGD","LU0889565916.HKD","LU0109394709.USD","SLE","IE00BN0W2T93.GBP","BK4532"],"gpt_icon":0},{"id":"2527549951","title":"Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE)","url":"https://stock-news.laohu8.com/highlight/detail?id=2527549951","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2527549951?lang=en_us&edition=fundamental","pubTime":"2025-04-14 20:00","pubTimestamp":1744632000,"startTime":"0","endTime":"0","summary":"– Recognizes potential of off-the-shelf CAR T-cell therapy to address significant unmet need and enables increased dialogue with FDA throughout the development process. – RMAT review by FDA included initial clinical safety and activity data from ongoing Phase 1 study of FT819 in SLE. SAN DIEGO, April 14, 2025  -- Fate Therapeutics, Inc. , a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell -derived off-the-shelf cellular immunotherapies to patients, today announced that the U.S. Food and Drug Administration  granted Regenerative Medicine Advanced Therapy  designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the treatment of active moderate to severe systemic lupus erythematosus , including lupus nephritis .The RMAT designation was established under the 21st Century Cures Act to expedite the development and review of regenerative medicine therapies for serious","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://finance.yahoo.com/news/fate-therapeutics-receives-regenerative-medicine-120000379.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":["FATE","IE00B66KJ199.SGD","BK4157","IE0031619046.USD","AEIS","IE00B7SZL793.SGD","IE00B19Z4B17.USD","BK4077","SLE","BK4139"],"gpt_icon":0},{"id":"2526384049","title":"Press Release: Artiva Biotherapeutics Appoints Subhashis Banerjee, M.D., as Chief Medical Officer","url":"https://stock-news.laohu8.com/highlight/detail?id=2526384049","media":"Dow Jones","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526384049?lang=en_us&edition=fundamental","pubTime":"2025-04-09 04:05","pubTimestamp":1744142700,"startTime":"0","endTime":"0","summary":"Dr. Banerjee's appointment culminates Artiva's efforts to build a seasoned development team with strong expertise in autoimmune diseases and cell therapy. Dr. Banerjee added, \"Artiva is leading the development of NK cell treatments for autoimmune disease, with the potential to offer a much-needed, long-term therapeutic option with an accessibility and safety profile that enables broad use in a community setting. The robust B-cell depletion seen with AlloNK through enhanced antibody-directed killing of cells in non-Hodgkin lymphoma bodes well for our opportunity to deeply deplete B-cells in patients with autoimmune diseases and to bring about meaningful clinical improvements and medication reductions. Artiva has built a very seasoned development team, and I am excited to lead the effort to further define the indications where AlloNK can be most impactful, and to help drive the program towards late-stage development.\"","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":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4077","BMS","R","BK4232","BK4022","RA","SLE","IIM","ARTV","BK4139"],"gpt_icon":0},{"id":"2525318890","title":"FDA Grants Three Fast Track Tags to Allogene's Autoimmune Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2525318890","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2525318890?lang=en_us&edition=fundamental","pubTime":"2025-04-08 18:46","pubTimestamp":1744109160,"startTime":"0","endTime":"0","summary":"Allogene Therapeutics ALLO announced that the FDA has granted three fast track designations to its investigational CRISPR-based allogeneic CAR-T therapy, ALLO-329.These designations apply to three autoimmune diseases — systemic lupus erythematosus , idiopathic inflammatory myopathy  and diffuse systemic sclerosis .How Does the Fast Track Tag Benefit ALLO’s Drug Development?Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, meet an unmet medical need, or offer a potential advantage over existing treatments. Per the FDA, the purpose of granting this designation is to ‘get important new drugs to the patient earlier.’。In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. 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