NEW YORK, Jan. 23, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Reata Pharmaceuticals, Inc. (“Reata” or the “Company”) (NASDAQ: RETA) and certain of its officers. The class action, filed in the United States District Court for the Eastern District of Texas, and docketed under 22-cv-00012, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Reata securities, and/or sold Reata put options, between November 9, 2020 and December 8, 2021, inclusive (the “Class Period”).  Plaintiff pursues claims against the Defendants under the Securities Exchange Act of 1934 (the “Exchange Act”).

If you are a shareholder who purchased Reata securities, and/or sold Reata put options, during the Class Period, you have until February 18, 2022 to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Reata is a clinical-stage biopharmaceutical company that focuses on small-molecule therapeutics.  One of its two lead product candidates is bardoxolone methyl (“bardoxolone”), which is being developed for multiple indications, including chronic kidney disease (“CKD”) caused by Alport syndrome (“AS”).

On March 1, 2021, Reata announced that it had submitted its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for bardoxolone as a treatment of CKD caused by AS.  The Phase 3 CARDINAL study was purportedly designed to measure the efficacy and safety of bardoxolone.  The primary endpoint for Year 2 was the change from baseline in estimated glomerular filtration rate (“eGFR”) after 100 weeks of treatment (end-of-treatment).  The key secondary endpoint for Year 2 was the change from baseline in eGFR at Week 104 (four weeks after last dose in second year of treatment).

The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects.  Specifically, Defendants failed to disclose to investors: (1) that the FDA had raised concerns regarding the validity of the clinical study designed to measure the efficacy and safety of bardoxolone for the treatment of CKD caused by AS; (2) that, as a result, there was a material risk that Reata’s NDA would not be approved; and (3) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

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 pharmacodynamic 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 to kidney failure.”

On this news, the Company’s stock price fell $29.77, or 38%, to close at $48.92 per share on December 6, 2021, on unusually heavy trading volume.

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, on unusually heavy trading volume.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:

Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980