Applied Therapeutics Settled With Investors Over Govorestat FDA Rejection – How to Claim Your Payout

Court: S.D. New York

Case: 1:24-cv-09715

Applied Therapeutics APLT has agreed to settle a lawsuit from investors over hiding dosing errors, missing trial data, and regulatory risks tied to its lead drug candidate, govorestat.

The settlement comes after the FDA rejected the company’s application in 2024, sending the stock crashing more than 80%.

What Really Happened With Govorestat

In 2023, Applied Therapeutics promoted positive results for Govorestat, its drug candidate for galactosemia, assuring investors that the trial data were strong and that FDA approval was on track.

But in late 2024, the FDA issued a Complete Response Letter, rejecting the application due to protocol errors, flawed dosing, and missing data. The disclosure blindsided investors, triggering an 80% stock drop in just a few days.

Investors Push Back—and Sue

In response, investors filed a lawsuit accusing Applied Therapeutics of misrepresenting the strength of its clinical trial data, downplaying regulatory risks, and overstating govorestat’s chances of approval.

The Deal That Finally Closed the Chapter

Now, Applied Therapeutics has agreed to settle with investors to resolve the claims. The agreement aims to provide compensation for shareholders who suffered losses with the FDA’s rejection. While the final details are still in progress, investors can already submit a claim to get payment. You can check more info and file your claim here.