A case was filed on Friday in the District of New Jersey by Christina Pham as a class action against Reata Pharmaceuticals Inc., J Warren Huff, and Manmeet S. Soni. The case alleges misrepresentations in press releases and Securities and Exchange Commission (SEC) related to the company’s New Drug Application (NDA) for Bardoxolone.
Bardoxolone is a drug intended to treat patients with chronic kidney disease caused by Alport Syndrome, per the complaint. The drug received clinical trials designed by the defendant as a part of the New Drug Application process with the Food and Drug Administration (FDA).
As a part of press releases and SEC form 10-Q, the defendant reported that the drug was progressing through the trial process and that the NDA submission was proceeding to officially receive approval from the FDA, the complaint said. However, the defendants allegedly did not mention that the FDA had questioned the design and efficacy of the testing protocol to show that the patients received positive benefits of the drug as early as 2018 and continuing until the FDA definitively stated that the testing was inadequate in December 2021.
The plaintiff accuses the defendants of intentionally omitting this information which caused a drastic drop in the price of the stock. The plaintiff is suing for violations of Section 10(b) and Rule 10b-5 as well as violations of section 20(a) of the Exchange Act. The plaintiff is represented by the Rosen Law Firm, PA.