Penny Stock Applied Therapeutics' FDA Troubles Trigger Investor Lawsuit, Shareholders Claim Deception Over Govorestat Clinical Data

Benzinga12-21 06:15

Adrian Alexandru, representing all similarly affected investors, has filed a federal securities class-action lawsuit against Applied Therapeutics (NASDAQ:APLT), alleging the company violated federal ...

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The class action covers investors who purchased Applied Therapeutics securities between January 3, 2024, and December 2, 2024.Central to the lawsuit are claims that the company touted positive results from its Phase 3 INSPIRE trial for govorestat for Galactosemia, without disclosing significant issues. Bloomberg Law published a copy of the lawsuit online.Allegations include problems with electronic data capture and dosing errors during the dose-escalation phase of ","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"CRL":"查尔斯河","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","APLT":"Applied Therapeutics Inc.","LU0390134368.USD":"FRANKLIN GLOBAL GROWTH \"A\" (USD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LENZ":"Therapeutics","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4121":"生命科学工具和服务","BK4585":"ETF&股票定投概念","BK4530":"医药外包概念","BK4588":"碎股","BK4139":"生物科技"},"translate_title":"细价股Applied Therapeutics的FDA麻烦引发投资者诉讼，股东声称Govorestat临床数据存在欺骗行为","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CRL":1,"LENZ":1,"APLT":0.9},"content_text":"Adrian Alexandru, representing all similarly affected investors, has filed a federal securities class-action lawsuit against Applied Therapeutics (NASDAQ:APLT), alleging the company violated federal securities laws.\nThe lawsuit claims that the company provided misleading information about its clinical trials and failed to disclose key adverse facts, causing significant financial losses for shareholders.\nAlso Read: Rare Disease-Focused Applied Therapeutics' Lead Candidate Govorestat Has Blockbuster Potential, Analyst Sees 140% Stock Upside\nThe class action covers investors who purchased Applied Therapeutics securities between January 3, 2024, and December 2, 2024.\nCentral to the lawsuit are claims that the company touted positive results from its Phase 3 INSPIRE trial for govorestat for Galactosemia, without disclosing significant issues. Bloomberg Law published a copy of the lawsuit online.\nAllegations include problems with electronic data capture and dosing errors during the dose-escalation phase of the study, which were concealed from investors.\nInvestor confidence began to erode on November 27, 2024, when Applied Therapeutics received an FDA Complete Response Letter (CRL).\nThe CRL indicated that the agency could not approve the company's New Drug Application for govorestat in its current form, citing deficiencies in the clinical application.\nFollowing the disclosure, Applied Therapeutics' stock price dropped sharply, which worsened after the company disclosed receiving a warning letter from the FDA on December 2 highlighting unresolved clinical trial issues.\nThe FDA's warning letter pointed to electronic data capture problems and a dosing error that resulted in lower-than-targeted doses for some patients during the trial's early phase.\nWhile Applied Therapeutics claims to have addressed these issues through detailed records and prior communications with the agency, investors reacted negatively to the revelations, further eroding the stock's value.\nThe lawsuit seeks to recover damages for investors who purchased shares at artificially inflated prices, alleging that the company's failure to provide accurate and complete information misled the market.\nOn Friday, Applied Therapeutics named John Johnson as executive chairman and announced that Shoshana Shendelman has stepped down as Chair and CEO. The company named Les Funtleyder, Applied Therapeutics' CFO, as the interim CEO.\nRBC Capital analyst maintains Applied Therapeutics with a Sector Perform, lowering the price target from $4 to $1.5.\nPrice Action: APLT stock closed lower by 13.7% to $0.87 on Friday.\nRead Next:\n\nKroger Launches $5 Billion Accelerated Share Repurchase: Details\n\nUp Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.\nGet the latest stock analysis from Benzinga?\n\nThis article Penny Stock Applied Therapeutics' FDA Troubles Trigger Investor Lawsuit, Shareholders Claim Deception Over Govorestat Clinical Data originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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