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

Zacks11-28 23:13

Applied Therapeutics APLT announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) seeking approval for APLT’s lead candidate, govorestat, to treat classic...

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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","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4599":"减肥药","BK4532":"文艺复兴科技持仓","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","ALLO":"Allogene Therapeutics Inc.","BK4592":"伊斯兰概念","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","BK4534":"瑞士信贷持仓","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4139":"生物科技","PFE":"辉瑞","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","BK4007":"制药","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","BK4566":"资本集团","BK4578":"CAR-T","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","SG9999002224.SGD":"Allianz Global High Payout SGD","LU0058720904.USD":"联博国际健康护理基金A","BK4121":"生命科学工具和服务","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","BK4550":"红杉资本持仓","BK4588":"碎股","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","BK4505":"高瓴资本持仓","APLT":"Applied Therapeutics Inc.","BK4581":"高盛持仓","GILD":"吉利德科学","SG9999001176.USD":"United Global Healthcare Acc USD","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","LU0234570918.USD":"高盛全球核心股票组合Acc Close","CRL":"查尔斯河","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","BK4583":"猴痘概念","LU1883839398.USD":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) ACC"},"translate_title":"FDA发布半乳糖血症药物NDA CRL后APLT股价暴跌77%","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"APLT":1,"ALLO":1,"PFE":1,"GILD":1,"CRL":1},"content_text":"Applied Therapeutics APLT announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) 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.\nApplied Therapeutics is evaluating 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.\nAPLT’s govorestat (also known as AT-007) 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. \nYear to date, shares of Applied Therapeutics have skyrocketed 155.8% against the industry’s 7.8% decline.\nImage Source: Zacks Investment Research\nPer APLT, clinical study results submitted in support of the govorestat NDA showed rapid and sustained reductions in galactitol upon treatment with the candidate, leading to meaningful clinical benefits for pediatric patients and a favorable safety profile. In the phase III ACTION-Galactosemia Kids study in children with galactosemia aged 2-17 years, govorestat improved daily activities, behavior, cognition, fine motor skills and tremor. It also significantly reduced plasma galactitol levels in adults and children with galactosemia. Additional studies provided strong efficacy and safety data across 185 classic galactosemia patients over three years.\nPer Applied Therapeutics, approximately 3,300 patients in the United States with 80-100 new births per year and approximately 4,400 patients in the EU with 120 new births per year suffer from galactosemia, a rare genetic metabolic disease.\nA regulatory filing for govorestat to treat classic galactosemia is also currently under review in the EU. The company expects a decision by the EU regulatory body early in the first quarter of 2025.\nOther Programs in APLT’s Clinical-Stage Pipeline\nApart from thegalactosemia indication, Applied Therapeutics is currently evaluating govorestat for two other indications, namely sorbitol dehydrogenase (SORD) deficiency and phosphomannomutase 2 deficiency (PMM2-CDG).\nThe company is gearing up to submit an NDA with the FDA for govorestat to treat the SORD indication early in the first quarter of 2025. Applied Therapeutics clarified that the review and potential approval of govorestat for treating SORD is independent of the ongoing review of govorestat for classic galactosemia.\nGovorestat enjoys the Orphan Medicinal Product designation in the EU for both galactosemia and SORD deficiency indications. Govorestat has also received Orphan Drug designation from the FDA for the treatment of galactosemia, PMM2-CDG and SORD deficiency, Pediatric Rare Disease designation for galactosemia and PMM2-CDG and Fast Track designation for galactosemia.\nBesides govorestat, APLT’s pipeline comprises two other investigational candidates — AT-001 is being studied for the treatment of diabetic cardiomyopathy, while AT-003 is being developed for diabetic retinopathy.\n\nApplied Therapeutics Inc. Price and Consensus\n\nApplied Therapeutics Inc. price-consensus-chart | Applied Therapeutics Inc. Quote\n\nZacks Rank & Stocks to Consider\nApplied Therapeutics currently carries a Zacks Rank #4 (Sell).\nSome better-ranked pharma stocks are Allogene Therapeutics ALLO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nOver the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 21.5% year to date.\nAllogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.\nOver the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.6% year to date.\nPfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.\nOver the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024 while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 12.8% year to date.\nGilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nAllogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report\nApplied Therapeutics Inc. (APLT) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2487345384"}