Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of February 18, 2025 in Applied Therapeutics Lawsuit – APLT

Key Takeaways:

• FDA Rejected Govorestat NDA: The FDA issued a Complete Response Letter, unable to approve the drug in its current form.
• Stock Price Dropped Over 80%: Shares fell from $10.21 to $1.29 within days.
• Class Action Lawsuit Filed: Levi & Korsinsky is seeking to recover investor losses due to alleged securities fraud.
• Disclosure of FDA Warning Letter: A subsequent warning letter further decreased investor confidence.
• Investor Deadline on February 18, 2025: Affected investors must act before this date to seek lead plaintiff status.

Applied Therapeutics Faces Legal Action Following FDA Setback

Applied Therapeutics, Inc. (NASDAQ: APLT) is confronting a class action securities lawsuit filed by the law firm Levi & Korsinsky, LLP. The lawsuit alleges that the company engaged in securities fraud, leading to significant losses for investors during the period between January 3, 2024, and December 2, 2024.

FDA Issues Complete Response Letter

On November 27, 2024, Applied Therapeutics announced it had received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for govorestat, the company’s lead drug candidate. The CRL indicated that the FDA was unable to approve the NDA in its current form, citing “deficiencies in the clinical application.”

Impact on Stock Prices

The announcement had an immediate and dramatic impact on the company’s stock price. Closing at $10.21 per share on November 26, 2024, the stock plummeted to $8.57 per share the following day. The decline continued over the next few days, dropping to $2.03 on November 29 and sliding further to $1.75 per share by December 2, 2024. This represents a total decline of more than 80% in less than a week.

Disclosure of FDA Warning Letter Intensifies Concerns

After market hours on December 2, 2024, Applied Therapeutics disclosed it had received a “warning letter” from the FDA pertaining to clinical trial issues underlying the CRL. This revelation exacerbated investor concerns, prompting additional declines in the stock price. Shares fell to $1.69 on December 3, dropped to $1.38 on December 4, and settled at $1.29 per share on December 5, 2024.

Class Action Lawsuit Filed by Levi & Korsinsky

Levi & Korsinsky, LLP has initiated a class action lawsuit seeking to recover losses on behalf of shareholders adversely affected by the alleged securities fraud. The complaint suggests that Applied Therapeutics may have misled investors regarding the viability of govorestat’s approval, failing to disclose significant issues that led to the FDA’s rejection.

Investor Deadline Approaching

Investors who purchased Applied Therapeutics securities during the specified period and suffered losses have until February 18, 2025, to request that the court appoint them as lead plaintiff. Serving as a lead plaintiff is not a requirement to share in any potential recovery but allows investors to take a more active role in the litigation process.

What This Means for Investors

The unfolding legal situation underscores the importance of transparency and regulatory compliance for biotech companies. Investors affected by the steep decline in Applied Therapeutics’ stock price are encouraged to consider their legal options. According to Levi & Korsinsky, there are no out-of-pocket costs or fees for participating in the lawsuit.

Affected investors can contact Levi & Korsinsky for more information via email at