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Applied Therapeutics Inc.

0.3440

+0.01143.43%

Post-market: 0.3341-0.0099-2.88%16:52 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

FDA Rejects Applied Therapeutics' NDA for Govorestat, Citing Flaws; Shares Plunge 76%

Applied Therapeutics (APLT) Stock Plunges 75% as FDA Rules Against Genetic Drug

Dow, S&P 500 End November at Record Highs

Biotech Stock Roundup: BBIO Stock Up on Drug Approval, SAVA, APLT Plunge on Setbacks & More

Applied Therapeutics Is Maintained at Outperform by Baird

Top Midday Decliners

MT Newswires Live

Sector Update: Health Care Stocks Rise in Afternoon Trading

MT Newswires Live

BUZZ-Soleno falls after FDA rejects peer Applied's genetic disease drug

Applied Therapeutics target lowered to $8, ‘catalyst watch’ removed at Citi

US STOCKS-S&P 500 hits record high as major indexes rise on tech, retail stocks

Top Stock Movers Now: Hasbro, MicroStrategy, Super Micro Computer, and More

Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. -- Barrons.com

BUZZ-Applied Therapeutics falls over 70% as FDA rejects genetic disease drug

Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug

Applied Therapeutics' Govorestat Faces Unclear Regulatory Path After FDA Rejection, RBC Says

MT Newswires Live

Applied Therapeutics Shares Drop 75% After U.S. FDA Declines to Approve Co's Genetic Disease Drug

THOMSON REUTERS

Stock Track | Applied Therapeutics Plunges 75% as FDA Rejects Govorestat for Galactosemia, Analysts Slash Outlook

Sector Update: Health Care Stocks Advance Pre-Bell Friday

MT Newswires Live

US STOCKS-Wall St set for higher open in shorter Black Friday session

US Equity Futures Tread Water Ahead of Shortened Black Friday Session

MT Newswires Live

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Our strong commitment to the Galactosemia community is rooted in our belief that govorestat has the potential to change the lives of patients with Galactosemia.\". During clinical studies, Govorestat, a central nervous system penetrant aldose reductase inhibitor, has rapidly and consistently lowered galactitol levels, producing favorable results for young patients. 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Among these, BridgeBio Pharma, Inc. BBIO gained on approval of cardiovascular drug while a few others faced setbacks.BridgeBio Pharma, Inc. announced that it has obtained FDA approval for its pipeline candidate acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy  to reduce cardiovascular death and cardiovascular-related hospitalization. The candidate has been approved under the brand name Attruby. BBIO stock surged on the news.The FDA approval is based on positive results from the phase III ATTRibute-CM study, in which Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life. The approval came ahead of the targeted action date of Nov. 29.MariTide caused approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. In patients with type II diabetes who were obese or overweight, the weight loss reduction was ","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/0.VF5p.GUKhgU24gMni2XA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/59a827b8514d5d6d47690daa5eb16f24","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/0.VF5p.GUKhgU24gMni2XA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/59a827b8514d5d6d47690daa5eb16f24"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/biotech-stock-roundup-bbio-stock-185100614.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":["LU2242652126.USD","BK4534","APLT","BK4581","LU1023059063.AUD","BK4566","LU1057294990.SGD","AMGN","LU1571399168.USD","BK4585","LU1983299246.USD","IE00BFTCPJ56.SGD","LU0289739699.SGD","LU0058720904.USD","LU2112291526.USD","BK4533","BK4547","SAVAW","BK4599","SAVA","IE00B2B36J28.USD","LU0109394709.USD","LU0889565916.HKD","BK4139","LU1061106388.HKD","IE0009355771.USD","IE00BJT1NW94.SGD","LU2242646821.SGD","IE00BJJMRZ35.SGD","LU0122379950.USD","BK4007","BK4505","IE0002141913.USD","SG9999001440.SGD","LU0868494617.USD","BBIO","BK4588","LU0320765992.SGD","IE00B4R5TH58.HKD"],"gpt_icon":1},{"id":"2487059363","title":"Applied Therapeutics Is Maintained at Outperform by Baird","url":"https://stock-news.laohu8.com/highlight/detail?id=2487059363","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487059363?lang=en_us&edition=fundamental","pubTime":"2024-11-30 02:20","pubTimestamp":1732904400,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/APLT/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 29, 2024 13:20 ET (18:20 GMT)","market":"sg","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":["LENZ","APLT"],"gpt_icon":0},{"id":"2487598353","title":"Top Midday Decliners","url":"https://stock-news.laohu8.com/highlight/detail?id=2487598353","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487598353?lang=en_us&edition=fundamental","pubTime":"2024-11-30 01:58","pubTimestamp":1732903130,"startTime":"0","endTime":"0","summary":"Applied Therapeutics (APLT) late Wednesday said the US Food and Drug Administration has issued a complete response letter indicating its decision to not approve a new drug application for the company'","market":"sh","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4139","RMBL","LU0889565916.HKD","BK4214","BK4122","APVO","LU0109394709.USD","LU0320765992.SGD","APLT"],"gpt_icon":0},{"id":"2487560039","title":"Sector Update: Health Care Stocks Rise in Afternoon Trading","url":"https://stock-news.laohu8.com/highlight/detail?id=2487560039","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487560039?lang=en_us&edition=fundamental","pubTime":"2024-11-30 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drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2487560566","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487560566?lang=en_us&edition=fundamental","pubTime":"2024-11-30 01:40","pubTimestamp":1732902030,"startTime":"0","endTime":"0","summary":"BUZZ-Soleno falls after FDA rejects peer Applied's genetic disease drug** Shares of Soleno Therapeutics SLNO.O fall 6.1% to $52.41** On Tuesday, U.S. FDA extended the review of SLNO's drug to treat a rare genetic disorder Prader–Willi syndrome** Investors are overreading into Applied's APLT.O FDA outcome - brokerage Baird** On Friday, FDA rejects APLT's drug to treat galactosemia, a rare genetic metabolic disease** Baird says SLNO's drug DCCR meets FDA's standard of substantial evidence of effectiveness at face value** In SLNO's study, in consultation with the FDA, DCCR met the main goal, whereas APLT's drug missed the main goal in its study - brokerage** SLNO has FDA's breakthrough designation for DCCR, while APLT does not - Baird** SLNO has a stronger application for approval and more external validation from the FDA - brokerage** FDA will decide on SLNO's drug by Mar. 27** YTD, SLNO up 28.8%  ","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:nL3N3N013G: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","BK4139","SLNO","LU0320765992.SGD","APLT"],"gpt_icon":0},{"id":"2487605385","title":"Applied Therapeutics target lowered to $8, ‘catalyst watch’ removed at Citi","url":"https://stock-news.laohu8.com/highlight/detail?id=2487605385","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487605385?lang=en_us&edition=fundamental","pubTime":"2024-11-30 01:30","pubTimestamp":1732901409,"startTime":"0","endTime":"0","summary":"Citi analyst Yigal Nochomovitz lowered the firm’s price target on Applied Therapeutics (APLT) to $8 from $13 and keeps a Buy rating on the shares, ...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/applied-therapeutics-target-lowered-to-8-catalyst-watch-removed-at-citi?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-target-lowered-to-8-catalyst-watch-removed-at-citi?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":["LENZ","LU0320765992.SGD","LU0889565916.HKD","APLT","LU0109394709.USD","BK4139"],"gpt_icon":0},{"id":"2487564071","title":"US STOCKS-S&P 500 hits record high as major indexes rise on tech, retail stocks","url":"https://stock-news.laohu8.com/highlight/detail?id=2487564071","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487564071?lang=en_us&edition=fundamental","pubTime":"2024-11-30 00:56","pubTimestamp":1732899378,"startTime":"0","endTime":"0","summary":"US STOCKS-S&P 500 hits record high as major indexes rise on tech, retail stocksS&P 500 hits record intraday high Nvidia leads tech stocks, retail stocks edge upApplied Therapeutics plummets after FDA declines drug approvalMarkets to close at 1:00 p.m. ETIndexes up: Dow 0.45%, S&P 500 0.51%, Nasdaq 0.68%Updates to midday tradingBy Johann M Cherian, Purvi Agarwal and Saeed Azhar. The S&P 500 index hit a record high as Wall Street's main indexes rose in a shortened Black Friday session, lifted by select technology stocks, while retail was in focus as the holiday shopping season kicked off.","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:nL3N3N0115:1","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":null,"symbols":["IE00B1BXHZ80.USD","IE00BMPRXN33.USD","LU1868836591.USD","IE0009356076.USD","3NVD.UK","LU0823414551.USD","LU1923623000.USD","NVD","LU1116320737.USD","M","LU0289739343.SGD","NVDX","LU0868494617.USD","LU2125154778.USD","NVD2.UK","LU2125909916.SGD","MSTR","NVDS.UK","LU0198837287.USD","TGT","NKE","NVDA","HAS","LU1435385759.SGD","LU0345770308.USD","LU2756315318.SGD","SNVD.UK","NVDS","NVD3.UK","2NVD.UK","APLT","LU2023250504.SGD","IE00B19Z9505.USD","LU1839511570.USD","LU0985320562.USD","IE00BJLML261.HKD","LU0053666078.USD","BK4566","NVDD","LU0868494708.USD","BK4579","BK4592","IE0004091025.USD","LU2552382058.USD","LU2087625088.SGD","NVDY","LU0820561909.HKD","NVDU"],"gpt_icon":1},{"id":"2487642705","title":"Top Stock Movers Now: Hasbro, MicroStrategy, Super Micro Computer, and More","url":"https://stock-news.laohu8.com/highlight/detail?id=2487642705","media":"Investopedia","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487642705?lang=en_us&edition=fundamental","pubTime":"2024-11-29 23:49","pubTimestamp":1732895353,"startTime":"0","endTime":"0","summary":"U.S. equities headed to Friday's early close—and the conclusion of November trading—in positive territory as the post-election market optimism continued.Hasbro shares gained when Elon Musk suggested he might be interested in buying the toymaker.Super Micro Computer shares sank as the server maker deals with the threat of delisting on the Nasdaq.U.S. equities were higher in morning trading in this shortened session, as the enthusiasm following the presidential election continued, helpingstocks head toward strong gains for the month of November. The Dow Jones Industrial Average, S&P 500, and Nasdaq were up.Hasbro  shares jumped when Elon Musk hinted on his social media platform, X, that he might be interested in buying the toy company.It was another record-setting performance for shares of Unusual Machines  following Wednesday's announcement that Donald Trump Jr. had joined the drone parts maker's advisory board.The price of bitcoin and other major cryptocurrencies rose, helping to lift ","market":"fut","thumbnail":"https://www.investopedia.com/thmb/iHPqvjKIY_i0BLSF5U8o4dzRZec=/6544x3736/filters:no_upscale():max_bytes(150000):strip_icc()/GettyImages-1362610245-43beed58968f423681ec1baa9dc35a39.jpg","type":0,"news_type":0,"thumbnails":["https://www.investopedia.com/thmb/iHPqvjKIY_i0BLSF5U8o4dzRZec=/6544x3736/filters:no_upscale():max_bytes(150000):strip_icc()/GettyImages-1362610245-43beed58968f423681ec1baa9dc35a39.jpg"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.investopedia.com/top-stock-movers-now-hasbro-microstrategy-super-micro-computer-and-more-8753304","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":"investopedia_highlight","symbols":["BK4595","BK7095","BK4190","BK4139","BK4588","BK4157","LU0320765992.SGD","BK4600","BK4596","BK4023","LU0053671581.USD","BK4585","BK4170","MSTR","NQmain","APLT","LU1861215975.USD","LU0109394709.USD","UMAC","HAS","MSTR.AU","LU0889565916.HKD","BK4566","HAS.AU","LU1861220033.SGD","BK4516"],"gpt_icon":1},{"id":"2487661025","title":"Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. -- Barrons.com","url":"https://stock-news.laohu8.com/highlight/detail?id=2487661025","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487661025?lang=en_us&edition=fundamental","pubTime":"2024-11-29 23:48","pubTimestamp":1732895280,"startTime":"0","endTime":"0","summary":"Applied Therapeutics stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease.Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%.The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited \"deficiencies in the clinical application\" of the drug, which it's marketing as govorestat.Founder and CEO Shoshana Shendelman said she was \"disappointed by the FDA's decision,\" adding that Applied Therapeutics would \"work with the FDA to address the concerns\" raised in its letter.It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the ye","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":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["APLT","LU0109394709.USD","LU0320765992.SGD","LU0889565916.HKD","LENZ","MMAT","BK4141","BK4139"],"gpt_icon":1},{"id":"2487563970","title":"BUZZ-Applied Therapeutics falls over 70% as FDA rejects genetic disease drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2487563970","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487563970?lang=en_us&edition=fundamental","pubTime":"2024-11-29 23:14","pubTimestamp":1732893243,"startTime":"0","endTime":"0","summary":"BUZZ-Applied Therapeutics falls over 70% as FDA rejects genetic disease drugUpdates** Applied Therapeutics' APLT.O shares fall 72.1% to $2.39, set for a record single-day drop** The U.S. FDA on Wednesday declined to approve APLT's drug to treat galactosemia, a rare genetic metabolic disease** The FDA's letter cited \"deficiencies in the clinical application\" for the drug, called govorestat, APLT says** Brokerage William Blair says the letter was \"unexpected and disappointing\" but believes it does not increase the regulatory risk for govorestat's approval for SORD deficiency, another rare genetic metabolic condition** Including session's losses, stock down 28.4% 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:20241129:nL3N3N00ZB: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":["APLT","LU0320765992.SGD","BK4139","LU0109394709.USD","LU0889565916.HKD"],"gpt_icon":0},{"id":"2487056526","title":"Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2487056526","media":"Investopedia","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487056526?lang=en_us&edition=fundamental","pubTime":"2024-11-29 23:06","pubTimestamp":1732892804,"startTime":"0","endTime":"0","summary":"Applied Therapeutics' application for a treatment of a rare metabolic disease was rejected by the Food and Drug Administration.The FDA said the drug, govorestat for galactosemia, had \"deficiencies in the clinical application.\"The news sent shares of Applied Therapeutics plunging 75% Friday morning.Applied Therapeutics  shares cratered Friday as the biopharmaceutical firm reported that the Food and Drug Administration  rejected its application for its experimental treatment for a rare metabolic disease known as Galactosemia.The company said it had received a Complete Response Letter  from the FDA that explained that after it completed a review of the drug, govorestat, it was unable to approve Applied Therapeutics' New Drug Application  in its current form. The FDA pointed to \"deficiencies in the clinical application.\". Patients with Galactosemia cannot process the simple sugar galactose. The company noted that approximately 3,300 people in the U.S. suffer from the disease, as well as 4,","market":"us","thumbnail":"https://www.investopedia.com/thmb/4ZZp5JvCDI3gkZJwWjUEQgA3Hbo=/3543x2362/filters:no_upscale():max_bytes(150000):strip_icc()/GettyImages-1236962131-84c386e68ae54159b31b09fc5499fa93.jpg","type":0,"news_type":0,"thumbnails":["https://www.investopedia.com/thmb/4ZZp5JvCDI3gkZJwWjUEQgA3Hbo=/3543x2362/filters:no_upscale():max_bytes(150000):strip_icc()/GettyImages-1236962131-84c386e68ae54159b31b09fc5499fa93.jpg"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.investopedia.com/applied-therapeutics-stock-plummets-after-fda-rejects-metabolic-disease-drug-8753289","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":"investopedia_highlight","symbols":["BK4585","BK4156","LU0109394709.USD","LENZ","BK4530","APLT","BK4121","LU0320765992.SGD","LU0390134368.USD","CEO","CRL","CRL.AU","LU0889565916.HKD","BK7095","BK4588","BK4139"],"gpt_icon":0},{"id":"2487501565","title":"Applied Therapeutics' Govorestat Faces Unclear Regulatory Path After FDA Rejection, RBC Says","url":"https://stock-news.laohu8.com/highlight/detail?id=2487501565","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487501565?lang=en_us&edition=fundamental","pubTime":"2024-11-29 22:41","pubTimestamp":1732891271,"startTime":"0","endTime":"0","summary":"Applied Therapeutics'  lead drug govorestat faces \"significant uncertainties\" around a regulatory path in galactosemia after the US Food and Drug Administration rejected its application, although it still has a potential path forward in sorbitol dehydrogenase, or SORD, deficiency, RBC Capital Markets said in a note Friday.Applied Therapeutics said earlier this week that the FDA rejected its new drug application for govorestat in galactosemia, citing deficiencies in the clinical package.RBC analysts said the company would likely need to conduct another clinical trial, \"pushing back galactosemia timelines meaningfully and adding considerable risk.\" This would push the timeline of govorestat in galactosemia by at least three years and reduce the program's probability of success to 20% from the previous estimate of 70%, the analysts said.Applied Therapeutics plans to file a new drug application for govorestat in SORD deficiency in Q1, but \"there remain uncertainties as to whether [Applied ","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://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["LU0109394709.USD","LU0320765992.SGD","LENZ","LU0889565916.HKD","APLT","BK4139"],"gpt_icon":0},{"id":"2487550396","title":"Applied Therapeutics Shares Drop 75% After U.S. FDA Declines to Approve Co's Genetic Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2487550396","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487550396?lang=en_us&edition=fundamental","pubTime":"2024-11-29 22:38","pubTimestamp":1732891088,"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:nFWN3N007J: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":["LU0320765992.SGD","APLT","LU0109394709.USD","LU0889565916.HKD","BK4139"],"gpt_icon":0},{"id":"1137881773","title":"Stock Track | Applied Therapeutics Plunges 75% as FDA Rejects Govorestat for Galactosemia, Analysts Slash Outlook","url":"https://stock-news.laohu8.com/highlight/detail?id=1137881773","media":"Stock Track","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1137881773?lang=en_us&edition=fundamental","pubTime":"2024-11-29 22:32","pubTimestamp":1732890774,"startTime":"0","endTime":"0","summary":"Applied Therapeutics Inc.  shares plummeted over 75% in the pre-market session on Friday, following the U.S. Food and Drug Administration's  decision to reject the company's New Drug Application  for govorestat in treating classic galactosemia, a rare genetic metabolic disorder.The FDA issued a Complete Response Letter  to APLT, stating that the clinical application for govorestat had deficiencies and failed to meet the necessary requirements for approval. This unexpected setback has led analyst","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":null,"news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["APLT"],"gpt_icon":0},{"id":"2487055739","title":"Sector Update: Health Care Stocks Advance Pre-Bell Friday","url":"https://stock-news.laohu8.com/highlight/detail?id=2487055739","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487055739?lang=en_us&edition=fundamental","pubTime":"2024-11-29 22:17","pubTimestamp":1732889856,"startTime":"0","endTime":"0","summary":"Health care stocks advanced pre-bell Friday with the Health Care Select Sector SPDR Fund  and iShares Biotechnology ETF  0.2% higher recently.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.\" Applied Therapeutics shares tumbled by over 74% premarket.RadNet's  shares were almost 4% higher after its DeepHealth unit said it received expanded US Food and Drug Administration 510 clearance for its SmartMammo mammography software.TC BioPharm  shares were down 12% after the company filed a registration statement with the US Securities and Exchange Commission Wednesday for the potential sale of up to $100 million of securities from time to time in one or more offerings.","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":["LU0109394709.USD","APLT","LU2065731478.USD","RDNT","BK4581","XLV","BK4139","TCBP","BK4588","LU0320765992.SGD","IBB","BK4196","BK4585","LU0889565916.HKD"],"gpt_icon":0},{"id":"2487522705","title":"US STOCKS-Wall St set for higher open in shorter Black Friday session","url":"https://stock-news.laohu8.com/highlight/detail?id=2487522705","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487522705?lang=en_us&edition=fundamental","pubTime":"2024-11-29 22:12","pubTimestamp":1732889526,"startTime":"0","endTime":"0","summary":"US STOCKS-Wall St set for higher open in shorter Black Friday sessionFor a Reuters live blog on U.S., UK and European stock markets, click LIVE/ or type LIVE/ in a news window.Retailers edge up ahead of Black Friday tradingApplied Therapeutics plummets after FDA declines drug approvalMarkets to close at 1:00 p.m. ETFutures up: Dow 0.19%, S&P 500 0.15%, Nasdaq 0.09%Updates before market openBy Johann M Cherian and Purvi Agarwal. U.S. stocks were on track for a slightly higher open on Black Friday, with Wall Street's main indexes set for monthly gains as the holiday shopping season kicked off, putting retail companies in the spotlight.\"But so far...  looking pretty solid for the Black Friday, Cyber Monday sale.\"","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"ea18a97b72e7ed0edfaf1d3713584fd1","theme_name":"🔥TrendingNo.19 · Stock Movements and Black Friday Shopping","theme_type":2,"isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241129:nL3N3N00W0:1","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":["IE000M9KFDE8.USD","LU2237443978.SGD","LU2237443622.USD","LU0320765992.SGD","BK4592","LU2237443549.SGD","BK4558","LU0211327993.USD","LU1989772923.USD","LU0211328371.USD","LU1116320737.USD","LU0823411888.USD","LU0256863811.USD","TGT","LU1430594728.SGD","LU2505996681.GBP","BK4561","LU1066051225.USD","TJX","BK4516","APLT","BK4595","LU0109394709.USD","IE00B1BXHZ80.USD","LU0094547139.USD","LU2506952097.USD","LU1066051498.USD","IE00BZ9MQY76.HKD","LU2237443465.HKD","MSTR","LU2237443895.HKD","LU2092937221.SGD","BK4155","BK4588","LU2361044949.HKD","WMT","BK4114","LU2506952170.USD","LU0314104364.USD","LU2360032135.SGD","LU0052756011.USD","BK4094","BTBT","BK4139","LU1303367103.USD","NKE","BK4585","IE00B19Z9Z06.USD","LU1035773651.USD"],"gpt_icon":1},{"id":"2487522765","title":"US Equity Futures Tread Water Ahead of Shortened Black Friday Session","url":"https://stock-news.laohu8.com/highlight/detail?id=2487522765","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2487522765?lang=en_us&edition=fundamental","pubTime":"2024-11-29 21:56","pubTimestamp":1732888580,"startTime":"0","endTime":"0","summary":"US equity futures were little changed before Friday's opening bell as traders returned from the Thanksgiving holiday ahead of a shortened trading session on Wall Street.Dow Jones Industrial Average futures and S&P 500 futures each increased 0.1% and Nasdaq futures were marginally up.US stock markets will close early at 1 pm ET.Oil prices were higher, with front-month global benchmark North Sea Brent crude up 0.2% at $72.92 per barrel and US West Texas Intermediate crude 0.7% higher at $69.22 per barrel.In other world markets, Japan's Nikkei closed 0.4% lower, Hong Kong's Hang Seng ended 0.3% higher, and China's Shanghai Composite finished 0.9% higher. UK's FTSE 100 slipped 0.2%, while Germany's DAX index gained 0.4% in Europe's early afternoon session.In equities, shares of Nano Nuclear Energy  were 1.9% higher pre-bell after the company said late Wednesday it closed a $60 million private placement of common shares and warrants.On the losing side, Applied Therapeutics  shares slumped 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