NEW YORK, NY / ACCESSWIRE / December 12, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Applied Therapeutics, Inc. ("Applied Therapeutics, Inc.") (NASDAQ:APLT) concerning possible violations of federal securities laws.
Applied Therapeutics issued a press release on November 27, 2024, announcing "that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia." According to the Company, "[t]he CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application."
Following this news, Applied Therapeutics' stock price fell sharply during after-hours trading on the same day. To obtain additional information, go to:
https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=116312&wire=1
or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212)363-7500.
WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
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jlevi@levikorsinsky.com
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SOURCE: Levi & Korsinsky, LLP
View the original press release on accesswire.com