NEW YORK, January 27, 2022 /PRNewswire/ — 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 United States District Court for the Eastern District of Texasand registered under 22-cv-00012, is on behalf of a class consisting of all persons and entities other than defendants who have purchased or otherwise acquired Reata securities and/or sold Reata put options, among November 9, 2020 and December 8, 2021, inclusive (the “Class Period”). Plaintiff is pursuing claims against 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 ask the court to name you as the 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 applying by email are encouraged to include their mailing address, phone number and number of shares purchased.
[Click here for information about joining the class action]
Reata is a clinical-stage biopharmaceutical company focused on small molecule therapeutics. One of its two lead product candidates is bardoxolone methyl (“bardoxolone”), which is in development for multiple indications, including chronic kidney disease (“CKD”) caused by Alport syndrome ( “AS”).
At March 1, 2021, Reata announced that it had submitted its New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) for bardoxolone as a treatment for CKD caused by AS. The phase 3 CARDINAL study was supposed 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 the last dose of the second year of treatment).
The Complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, and failed to disclose material adverse facts regarding the Company’s business, operations and prospects. Specifically, the 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, therefore, there was a significant 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 reasonable basis.
At December 6, 2021, the FDA released briefing materials ahead of a meeting of the company’s NDA advisory committee for bardoxolone, indicating that throughout clinical development, the agency repeatedly questioned the validity of the design of the Reata study, as the pharmacodynamic effect of bardoxolone on renal function would make the results difficult. to assess drug efficacy. Although the FDA agreed that Reata’s Phase 3 study had met its endpoints, “the FDA review team d[id] I do not believe that the submitted data demonstrates that bardoxolone is effective in slowing the loss of renal function in patients with AS and reducing the risk of progression to renal failure. »
At this news, the Company’s share price fell. $29.77i.e. 38%, to close at $48.92 per share on December 6, 2021on an unusually high volume of transactions.
Then, on December 8, 2021the FDA advisory committee unanimously decided that bardoxolone was not effective based on the data submitted.
At this news, the Company’s share price fell. $25.31i.e. 46%, to close at $29.11 per share on December 9, 2021on an unusually high volume of transactions.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Parisand Tel Aviv, is recognized as one of the leading firms in the areas of corporate litigation, securities and antitrust. 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 the tradition he established, fighting for the rights of victims of securities fraud, breaches of fiduciary duty and corporate misconduct. The firm recovered numerous multimillion-dollar damages on behalf of class members. See www.pomlaw.com.
CONTACT:
Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980
SOURCE Pomerantz LLP
