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Applied Therapeutics Inc.

0.3440

+0.01143.43%

Post-market: 0.34410.0001+0.03%19:58 EDT

Volume:4.50M

Turnover:1.51M

Market Cap:48.70M

PE:-0.45

High:0.3480

Open:0.3300

Low:0.3210

Close:0.3326

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Overview Company News Filings

RBC downgrades Applied Therapeutics as FDA rejects Govorestat, hacks price target

Update: Applied Therapeutics' Shares Fall After FDA Rejects NDA for Govorestat in Classic Galactosemia

MT Newswires Live

Exchange-Traded Funds, Equity Futures Higher Pre-Bell Friday Ahead of US Farm Prices Data

MT Newswires Live

Top Premarket Decliners

MT Newswires Live

Applied Therapeutics CRL a ‘major setback,’ says William Blair

Stock Track | Applied Therapeutics Plunges 71.76% Pre-market as RBC Downgrades, Slashes Price Target

U.S. RESEARCH ROUNDUP-Applied Therapeutics, Brown-Forman, Ulta Beauty

Applied Therapeutics Inc : Baird Cuts Target Price to $5 From $14

THOMSON REUTERS

RBC Downgrades Applied Therapeutics to Sector Perform From Outperform, Cuts Price Target to $4 From $12, Keeps Speculative Risk

MT Newswires Live

Applied Therapeutics Inc : RBC Cuts to Sector Perform From Outperform; Cuts Target Price to $4 From $12

THOMSON REUTERS

Applied Therapeutics Shares Drop 73.1% Premarket After U.S. FDA Declines to Approve Co's Genetic Disease Drug

THOMSON REUTERS

24H｜Nvidia and ASML Rise 1%; MicroStrategy Gains 4%; Archer Aviation Jumps 10%; Applied Therapeutics Plunges 74%

Tiger Newspress

APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA

BRIEF-Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat

Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter

BUZZ-Applied Therapeutics plummets after FDA declines to approve genetic disease drug

US FDA Rejects Applied Therapeutics' New Drug Application for Govorestat in Classic Galactosemia

MT Newswires Live

Applied Therapeutics Shares Down 82.73% at $1.48 in Extended Trade After US FDA Declines to Approve Genetic Disease Drug

THOMSON REUTERS

Applied Therapeutics trading resumes

Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application

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downgrades Applied Therapeutics as FDA rejects Govorestat, hacks price target","url":"https://stock-news.laohu8.com/highlight/detail?id=2487655260","media":"Investing.com","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487655260?lang=en_us&edition=fundamental","pubTime":"2024-11-29 21:46","pubTimestamp":1732887992,"startTime":"0","endTime":"0","summary":"Investing.com --RBC Capital Markets downgraded Applied Therapeutics Inc  stock to \"sector perform\" from \"outperform” citing increased risks after the U.S. Food and Drug Administration  rejected the company’s application for its experimental drug govorestat to treat galactosemia.Shares of Applied Therapeutics plunged 75% to $2 in premarket trading on Friday.RBC analyst Brian Abrahams in a note said the FDA’s issuance of a Complete Response Letter  for govorestat creates \"significant uncertainties\" about the drug’s future in the rare metabolic disorder, where no approved treatments exist.Abrahams said the FDA may require an additional clinical trial with more definitive outcomes, even though the company had already expressed openness to a narrower label or accelerated approval based on existing data.The analyst highlighted potential value in Applied Therapeutics' SORD deficiency program, which targets a larger patient population.\"There remain uncertainties as to whether APLT can assemble","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://finance.yahoo.com/news/rbc-downgrades-applied-therapeutics-fda-134632450.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":["LENZ","APLT"],"gpt_icon":0},{"id":"2487660554","title":"Update: Applied Therapeutics' Shares Fall After FDA Rejects NDA for Govorestat in Classic Galactosemia","url":"https://stock-news.laohu8.com/highlight/detail?id=2487660554","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487660554?lang=en_us&edition=fundamental","pubTime":"2024-11-29 21:34","pubTimestamp":1732887265,"startTime":"0","endTime":"0","summary":"Applied Therapeutics  shares fell over 75% premarket Friday after the company disclosed late Wednesday that the US Food and Drug Administration issued a complete response letter indicating its decision not to approve a new drug application for govorestat to treat classic galactosemia due to \"deficiencies in the clinical application.\"The drugmaker said it is reviewing the regulator's feedback and plans to request a meeting to discuss requirements for a potential NDA resubmission or appeal.Govorestat is also being developed to treat sorbitol dehydrogenase deficiency, the 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(APLT)’ complete response letter from the FDA for govorestat for the treatment of galactosemia is 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Wh","market":"hk","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":"Stock Track | Applied Therapeutics Plunges 71.76% Pre-market as RBC Downgrades, Slashes Price Target","news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["APLT"],"gpt_icon":1},{"id":"2487530855","title":"U.S. RESEARCH ROUNDUP-Applied Therapeutics, Brown-Forman, Ulta Beauty","url":"https://stock-news.laohu8.com/highlight/detail?id=2487530855","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487530855?lang=en_us&edition=fundamental","pubTime":"2024-11-29 19:31","pubTimestamp":1732879860,"startTime":"0","endTime":"0","summary":"Nov 29 (Reuters) - Wall Street securities analysts revised their ratings and price targets on several U.S.-listed companies, including Applied Therapeutics, Brown-Forman and Ulta Beauty on Friday.  HI","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.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_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":["LU1057294990.SGD","LU2242646821.SGD","SG9999003800.SGD","LU1066053197.SGD","PFE","SG9999002232.USD","LU0385154629.USD","BK4093","SW","BK4081","LU0234572021.USD","BK4581","BK4139","DSGX","LU0612318385.USD","BK4585","LU0868494617.USD","LU1066051498.USD","LU1989763690.USD","IE00BLSP4239.USD","BK4599","CF","LU1920063259.USD","LU0225284248.USD","SG9999011175.SGD","LU2360106947.USD","SJM","ULTA","BK4534","LU0612318971.USD","LENZ","SG9999002224.SGD","TXNM","BK4533","LU0289739699.SGD","LU0985481810.HKD","IE000M9KFDE8.USD","IE00B19Z3581.USD","LU1894683264.USD","LU0654597011.USD","LU1894683348.USD","DOMO","LU0889565916.HKD","LU0471298777.SGD","LU2360108059.USD","BK4136","LU0170899867.USD","APLT","SG9999001176.SGD","LU0823411888.USD"],"gpt_icon":1},{"id":"2487537483","title":"Applied Therapeutics Inc : Baird Cuts Target Price to $5 From $14","url":"https://stock-news.laohu8.com/highlight/detail?id=2487537483","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487537483?lang=en_us&edition=fundamental","pubTime":"2024-11-29 19:21","pubTimestamp":1732879264,"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:20241129:nFWN3N00JM: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":["LU0109394709.USD","BK4139","LU0320765992.SGD","LU0889565916.HKD","APLT"],"gpt_icon":0},{"id":"2487537572","title":"RBC Downgrades Applied Therapeutics to Sector Perform From Outperform, Cuts Price Target to $4 From $12, Keeps Speculative Risk","url":"https://stock-news.laohu8.com/highlight/detail?id=2487537572","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487537572?lang=en_us&edition=fundamental","pubTime":"2024-11-29 19:14","pubTimestamp":1732878871,"startTime":"0","endTime":"0","summary":"Applied Therapeutics (APLT) has an average rating of overweight and mean price target of $11.25, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research fr","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate","earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LENZ","APLT"],"gpt_icon":0},{"id":"2487153190","title":"Applied Therapeutics Inc : RBC Cuts to Sector Perform From Outperform; 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MicroStrategy Gains 4%; Archer Aviation Jumps 10%; Applied Therapeutics Plunges 74%","url":"https://stock-news.laohu8.com/highlight/detail?id=1119264582","media":"Tiger Newspress","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1119264582?lang=en_us&edition=fundamental","pubTime":"2024-11-29 10:00","pubTimestamp":1732845601,"startTime":"0","endTime":"0","summary":"$MARA Holdings(MARA)$ shares gained 2.5% in overnight trading. In a Wednesday post on X, MARA, formerly Marathon Digital, wrote that it acquired its latest batch of Bitcoin at an average price of $95,","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":true,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BITF","SOS","MARA","APLT","AMD","ASML","ACHR","RIOT","NVDA","CLSK","GRFS","MSTR"],"gpt_icon":1},{"id":"2487345384","title":"APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2487345384","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487345384?lang=en_us&edition=fundamental","pubTime":"2024-11-28 23:13","pubTimestamp":1732806780,"startTime":"0","endTime":"0","summary":"Applied TherapeuticsAPLT announced that the FDA has issued a Complete Response Letter  for the new drug application  seeking approval for APLT’s lead candidate, govorestat, to treat classic galactosemia. The CRL stated that the FDA has reviewed the application and cannot approve the NDA in its current form due to deficiencies in the clinical study results submitted in support of the application.Applied Therapeutics isevaluating the FDA's feedback. It intends to promptly request a meeting to discuss the requirements for a potential NDA resubmission or appeal of the decision, and appropriate next steps. Shares of the company tanked 77.3% in the after-market hours, following the disappointing news.APLT’s govorestat  is a novel central nervous system penetrant ARI, which is currently being developed for three rare neurological diseases. The NDA for govorestat for the galactosemia indication was accepted by the FDA in late February under its Priority Review pathway.Year to date, shares of A","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/T8SwUImUDIjgxL38j1nI4w--~B/aD00MTQ7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/17664ed95646b97db9beb170298a16b3","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/T8SwUImUDIjgxL38j1nI4w--~B/aD00MTQ7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/17664ed95646b97db9beb170298a16b3"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/aplt-stock-plunges-77-fda-151300400.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU2087621335.USD","SG9999001176.SGD","LU0225771236.USD","LU0058720904.USD","LU1023059063.AUD","LU0985481810.HKD","PFE","BK4121","BK4139","SG9999002224.SGD","BK4550","BK4007","IE00B19Z3B42.SGD","LU0321505868.SGD","BK4588","IE00BZ1G4Q59.USD","BK4578","GILD","IE00BBT3K403.USD","LU0320765992.SGD","LU0321505439.SGD","LU0234572021.USD","SG9999001176.USD","LU0234570918.USD","BK4592","BK4583","LU1430594728.SGD","BK4505","LU1066051498.USD","IE00BSNM7G36.USD","SGXZ57979304.SGD","SG9999013999.USD","BK4532","CRL","LU0868494617.USD","BK4566","LU1883839398.USD","APLT","LU1894683264.USD","BK4534","ALLO","BK4581","LU0456855351.SGD","BK4599","SG9999011175.SGD","LU0170899867.USD","LU0289739699.SGD","LU1571399168.USD","IE00B19Z3581.USD","LU1057294990.SGD"],"gpt_icon":1},{"id":"2486890373","title":"BRIEF-Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat","url":"https://stock-news.laohu8.com/highlight/detail?id=2486890373","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486890373?lang=en_us&edition=fundamental","pubTime":"2024-11-28 07:23","pubTimestamp":1732749800,"startTime":"0","endTime":"0","summary":"BRIEF-Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat Nov 27 (Reuters) - Applied Therapeutics Inc APLT.O:APPLIED THERAPEUTICS RECEIVE","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:20241127:nTUATHB7K: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","LU0889565916.HKD","LU0109394709.USD","APLT","LU0320765992.SGD"],"gpt_icon":0},{"id":"2486385169","title":"Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter","url":"https://stock-news.laohu8.com/highlight/detail?id=2486385169","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486385169?lang=en_us&edition=fundamental","pubTime":"2024-11-28 06:33","pubTimestamp":1732746780,"startTime":"0","endTime":"0","summary":"Applied Therapeutics shares dropped after hours after disclosing that the Food and Drug Administration issued a complete response letter for its new drug application for govorestat for treatment of classic galactosemia.The company's stock was 76% lower, at $2.04. It closed the regular session at $8.57, down about 16%.The company said it is reviewing the FDA's feedback and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision along with appropriate next steps.An FDA complete response letter indicates that an application can't be approved in its current form.Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol dehydrogenase deficiency.","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":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["APLT","LU0109394709.USD","BK4139","LENZ","LU0889565916.HKD","LU0320765992.SGD"],"gpt_icon":0},{"id":"2486388201","title":"BUZZ-Applied Therapeutics plummets after FDA declines to approve genetic disease drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2486388201","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486388201?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:59","pubTimestamp":1732744744,"startTime":"0","endTime":"0","summary":"BUZZ-Applied Therapeutics plummets after FDA declines to approve genetic disease drug** Shares of Applied Therapeutics APLT.O fall 80.3% to $1.70 after the bell** Company says the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic metabolic disease** The FDA's letter to the company said the marketing application for the drug, govorestat, cannot be approved in its current form, due to certain deficiencies - APLT** Galactosemia can cause neurological complications, including deficiencies in speech, cognition, behavior and motor skills** Up to last close, stock up more than double YTD  ","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:20241127:nL3N3MY1EX:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0109394709.USD","LU0889565916.HKD","BK4139","LU0320765992.SGD","APLT"],"gpt_icon":0},{"id":"2486388934","title":"US FDA Rejects Applied Therapeutics' New Drug Application for Govorestat in Classic Galactosemia","url":"https://stock-news.laohu8.com/highlight/detail?id=2486388934","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486388934?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:51","pubTimestamp":1732744272,"startTime":"0","endTime":"0","summary":"Applied Therapeutics  said late Wednesday that the US Food and Drug Administration issued a complete response letter indicating the health regulator's decision not to approve the new drug application for govorestat to treat classic galactosemia due to \"deficiencies in the clinical application.\"The drugmaker said it is reviewing the regulator's feedback and plans to request a meeting to discuss requirements for a potential NDA resubmission or appeal.Govorestat is also being developed to treat sorbitol dehydrogenase deficiency, the company said, adding it plans to file an NDA for that indication in Q1 2025.","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":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LU0109394709.USD","LU0889565916.HKD","BK4139","LU0320765992.SGD","APLT","LENZ"],"gpt_icon":0},{"id":"2486388351","title":"Applied Therapeutics Shares Down 82.73% at $1.48 in Extended Trade After US FDA Declines to Approve Genetic Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2486388351","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486388351?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:45","pubTimestamp":1732743910,"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:20241127:nL2N3MY130:1","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":["LU0889565916.HKD","APLT","BK4139","LU0320765992.SGD","LU0109394709.USD"],"gpt_icon":0},{"id":"2486580079","title":"Applied Therapeutics trading resumes","url":"https://stock-news.laohu8.com/highlight/detail?id=2486580079","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486580079?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:40","pubTimestamp":1732743611,"startTime":"0","endTime":"0","summary":"16:40 EST Applied Therapeutics (APLT) trading resumes Published first on TheFly – the ultimate source for real-time, market-moving breaking financi...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/applied-therapeutics-trading-resumes?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/applied-therapeutics-trading-resumes?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":["BK4139","LU0320765992.SGD","LU0889565916.HKD","LU0109394709.USD","APLT","LENZ"],"gpt_icon":0},{"id":"2486800640","title":"Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application","url":"https://stock-news.laohu8.com/highlight/detail?id=2486800640","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486800640?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:33","pubTimestamp":1732743180,"startTime":"0","endTime":"0","summary":"Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical application.Shares dropped 16% to $8.57 in post-marketing trading. Through Wednesday's close, the stock has more-than-doubled since the beginning of the year.The FDA issues a complete response letter when it decides not to approve a new drug application in its present form.The biopharmaceutical company on Wednesday said it is reviewing the feedback from the FDA and plans to immediately request a meeting to potentially resubmit the NDA for the treatment of galactosemia or appeal the decision along with appropriate next steps.\"We are disappointed by the FDA's decision today,\" Chief Executive Shoshana Shendelman said.Galactosemia is a progressive and debilitating disease without any existing treatment options, the executive added.Overall, Galactosemia a rare genetic disorder that prevents the body 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