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Applied Therapeutics Inc.

0.4349

+0.02486.05%

Post-market: 0.43500.0001+0.02%19:59 EDT

Volume:6.26M

Turnover:2.68M

Market Cap:50.60M

PE:-0.30

High:0.4504

Open:0.4100

Low:0.4000

Close:0.4101

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Overview Company News Filings

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

Applied Therapeutics’ NDA for govorestat receives negative response from FDA

US FDA declines to approve Applied Therapeutics' genetic disease drug

Applied Therapeutics Inc - Expects to Submit an Nda Early in Q1 of 2025

THOMSON REUTERS

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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":["CLSK","AMD","NVDA","GRFS","BITF","MARA","APLT","ACHR","MSTR","RIOT","SOS","ASML"],"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":["LU0234572021.USD","PFE","SG9999001176.USD","SG9999002224.SGD","APLT","CRL","LU0234570918.USD","LU0321505868.SGD","GILD","IE00BBT3K403.USD","IE00BZ1G4Q59.USD","LU1894683264.USD","LU1571399168.USD","SG9999011175.SGD","LU1023059063.AUD","BK4505","BK4532","LU0321505439.SGD","LU1057294990.SGD","LU0170899867.USD","LU1883839398.USD","BK4583","ALLO","LU0985481810.HKD","LU0058720904.USD","BK4121","BK4566","BK4139","LU2087621335.USD","LU0320765992.SGD","LU1430594728.SGD","LU0225771236.USD","IE00B19Z3581.USD","IE00B19Z3B42.SGD","BK4581","BK4534","BK4007","LU0868494617.USD","SG9999013999.USD","LU0456855351.SGD","SG9999001176.SGD","SGXZ57979304.SGD","LU0289739699.SGD","LU1066051498.USD","BK4588","BK4592","BK4550","BK4599","BK4578","IE00BSNM7G36.USD"],"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":["LU0109394709.USD","LU0889565916.HKD","LU0320765992.SGD","BK4139","APLT"],"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":"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":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["APLT","LENZ","LU0320765992.SGD","BK4139","LU0109394709.USD","LU0889565916.HKD"],"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  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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 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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":["APLT","BK4139","LU0109394709.USD","LU0889565916.HKD","LU0320765992.SGD","LENZ"],"gpt_icon":0},{"id":"2486800640","title":"Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug 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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 ","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","LENZ","LU0889565916.HKD","LU0109394709.USD","LU0320765992.SGD","BK4139"],"gpt_icon":0},{"id":"2486807226","title":"Applied Therapeutics’ NDA for govorestat receives negative response from FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2486807226","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486807226?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:15","pubTimestamp":1732742113,"startTime":"0","endTime":"0","summary":"Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for govoresta...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/applied-therapeutics-nda-for-govorestat-receives-negative-response-from-fda?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-nda-for-govorestat-receives-negative-response-from-fda?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["LU0889565916.HKD","BK4139","LU0320765992.SGD","APLT","LU0109394709.USD","LENZ"],"gpt_icon":0},{"id":"2486807148","title":"US FDA declines to approve Applied Therapeutics' genetic disease drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2486807148","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486807148?lang=en_us&edition=fundamental","pubTime":"2024-11-28 05:14","pubTimestamp":1732742094,"startTime":"0","endTime":"0","summary":"US FDA declines to approve Applied Therapeutics' genetic disease drugNov 27  - The U.S. Food and Drug Administration on Wednesday declined to approve Applied Therapeutics' APLT.O drug to treat galactosemia, a rare genetic metabolic disease, the company said.  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