NEW YORK, Feb. 4, 2022 — Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired securities, and/or sold put options of Reata Pharmaceuticals, Inc. (“Reata” or the “Company”) (NASDAQ: RETA) between November 14, 2016 and December 8, 2021, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Eastern District of Texas and alleges violations of the Securities Exchange Act of 1934.
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”).
According to the complaint, 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 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 chronic kidney disease caused by Alport syndrome; (ii) as a result, there was a material risk that Reata’s NDA would not be approved; and (iii) as a result of the foregoing, Defendants’ statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On March 1, 2021, Reata announced that it had submitted its New Drug Application (“NDA”) to the FDA for bardoxolone as a treatment of CKD caused by Alport syndrome (“AS”). The Company’s 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).
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.
If you wish to serve as lead plaintiff, you must move the Court no later than February 18, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
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