Attention Investors: Important Update on Applied Therapeutics Inc. Investigation

NEW YORK, NY / ACCESSWIRE / December 15, 2024

Overview

Levi & Korsinsky has recently initiated an investigation into Applied Therapeutics, Inc. (NASDAQ: APLT) regarding potential securities law violations. The investigation was prompted by a press release issued by Applied Therapeutics on November 27, 2024, which disclosed that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of govorestat.

What is govorestat?

Govorestat is a novel central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI) developed by Applied Therapeutics for the treatment of Classic Galactosemia, a rare genetic metabolic disorder. The CRL issued by the FDA indicates that there are deficiencies in the NDA that need to be addressed before govorestat can be approved for commercial use.

Potential Impact on Investors

Investors who have stakes in Applied Therapeutics, Inc. may be concerned about the implications of the FDA’s decision and the ongoing investigation into possible securities law violations. The uncertainty surrounding the approval of govorestat could affect the company’s stock value and future prospects.

How will this affect me?

As an investor in Applied Therapeutics, Inc., you may experience fluctuations in your investment portfolio as a result of the ongoing investigation and FDA’s CRL for govorestat. It is important to stay informed about any developments related to the company and seek guidance from financial advisors to make informed decisions.

How will this affect the world?

The outcome of the investigation and FDA’s decision on govorestat could have broader implications for the pharmaceutical industry and drug development process. The scrutiny of regulatory authorities and adherence to compliance standards play a crucial role in ensuring the safety and efficacy of new treatments for rare diseases like Classic Galactosemia.

Conclusion

As the investigation into Applied Therapeutics, Inc. unfolds and the FDA’s review of govorestat continues, investors and industry stakeholders will be closely monitoring the situation for any updates or developments that could impact the company’s future and the pharmaceutical landscape as a whole.