Applied Therapeutics, Inc. (APLT)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Applied Therapeutics, Inc. (“Applied Therapeutics” or “the Company”) (NASDAQ: APLT). Investors who purchased Applied Therapeutics securities are encouraged to obtain additional information and assist the investigation.
The investigation concerns whether Applied Therapeutics has violated federal securities laws.
Investigation Details
On November 27, 2024, Applied Therapeutics issued a press release 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.” On this news, Applied Therapeutics’ stock price fell $1.64 per share, or 16.06%, to close at $8.57 per share on November 27, 2024. Then, on December 3, 2024, the FDA posted on its website a Warning Letter to Applied Therapeutics, the contents of which indicated that the Company was aware at least as early as May 2024 that the FDA had identified significant issues in the govorestat NDA. On this news, Applied Therapeutics’ stock price fell $0.31 per share, or 18.34%, to close at $1.38 per share on December 4, 2024.
What’s Next?
If you are aware of any facts relating to this investigation or purchased Applied Therapeutics securities, you can assist this investigation. You can also contact Peretz Bronstein or his client relations manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660
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Contact
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Nathan Miller
332-239-2660 | [email protected]