Reata Pharmaceuticals, Inc. (RETA) Made Material Misstatements Regarding the Viability of its Drug Bardoxolone
A class action was filed on behalf of all persons and entities that purchased or otherwise acquired Reata Pharmaceutical, Inc. (NASDAQ: RETA) securities, and/or sold Reata put options, between November 9, 2020 and December 8, 2021. The complaint alleges violations of the Securities Exchange Act of 1934. Reata is a clinical-stage biopharmaceutical company that focuses on small-molecular therapeutics.
According to the complaint, on March 1, 2021, Reata announced it had submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bardoxolone as a treatment of chronic kidney disease caused by Alport syndrome (AS). During the class period, defendants failed to disclose to investors that the FDA had raised concerns regarding the viability of the clinical study designed to measure the efficacy and safety of the drug, and that as a result, there was a material risk that the FDA would not approve the NDA.
On December 6, 2021, the FDA released briefing documents in advance of an Advisory Committee meeting for the Company’s NDA for bardoxolone, stating that throughout the clinical development, the agency had repeatedly questioned the validity of Reata’s study design because bardoxolone’s pharmacodynamics effect on kidney function would make the results difficult to assess the effectiveness of the drug. Though the FDA agreed that Reata’s Phase 3 study met its endpoints, “the FDA review team d[id] not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression of kidney failure.” On this news, the Company’s stock price fell almost $30.00, or 38%, to close at $48.92 per share on December 6, 2021.
Then, on December 8, 2021, the FDA’s Advisory Committee unanimously decided that bardoxolone was not effective based on the submitted data. On this news, the Company’s stock price fell $25.31, or 46%, to close at $29.11 per share on December 9, 2021.
If you purchased shares of Reata Pharmaceuticals, Inc. (RETA) between November 9, 2020 and December 8, 2021, you have until February 18, 2022, to ask the court to appoint you lead plaintiff for the class.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.