SAN DIEGO--(BUSINESS WIRE)--Robbins Geller Rudman & Dowd LLP announces that purchasers of Reata Pharmaceuticals, Inc. (NASDAQ: RETA) securities and/or sellers of Reata Pharmaceuticals put options between November 9, 2020 and December 8, 2021, inclusive (the “Class Period”) have until February 18, 2021 to seek appointment as lead plaintiff in Doyle v. Reata Pharmaceuticals, Inc., No. 21-cv-00987 (E.D. Tex.). Commenced on December 20, 2021, the Reata Pharmaceuticals class action lawsuit charges Reata Pharmaceuticals and certain of its top executives with violations of the Securities Exchange Act of 1934.
If you wish to serve as lead plaintiff of the Reata Pharmaceuticals class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at firstname.lastname@example.org. Lead plaintiff motions for the Reata Pharmaceuticals class action lawsuit must be filed with the court no later than February 18, 2022.
CASE ALLEGATIONS: One of Reata Pharmaceuticals’ 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 Pharmaceuticals 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 Reata Pharmaceuticals class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) 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; (ii) as a result, there was a material risk that Reata’s NDA would not be approved; and (iii) as such, defendants’ positive statements about Reata Pharmaceuticals’ 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 Reata Pharmaceuticals’ NDA for bardoxolone, stating that throughout the clinical development, the agency had repeatedly questioned the validity of Reata Pharmaceuticals’ 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 Pharmaceuticals’ 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, Reata Pharmaceuticals’ stock price fell by approximately 38%.
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, Reata Pharmaceuticals’ stock price fell an additional 46%, further damaging investors.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Reata Pharmaceuticals securities and/or sold Reata Pharmaceuticals put options during the Class Period to seek appointment as lead plaintiff in the Reata Pharmaceuticals class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Reata Pharmaceuticals class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Reata Pharmaceuticals class action lawsuit. An investor’s ability to share in any potential future recovery of the Reata Pharmaceuticals class action lawsuit is not dependent upon serving as lead plaintiff.
ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions. Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm. Please visit http://www.rgrdlaw.com for more information.
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