A lawsuit was filed on behalf of investors in Reata Pharmaceuticals, Inc. (NASDAQ:RETA) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 01/27/2022 -- An investor, who purchased shares of Reata Pharmaceuticals, Inc. (NASDAQ: RETA), filed a lawsuit over alleged violations of Federal Securities Laws by Reata Pharmaceuticals, Inc.
Investors who purchased shares of Reata Pharmaceuticals, Inc. (NASDAQ: RETA) have certain options and for certain investors are short and strict deadlines running. Deadline: February 18, 2022. NASDAQ: RETA investors should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
On March 1, 2021, Reata Pharmaceuticals, Inc 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 chronic kidney disease ("CKD") caused by Alport syndrome ("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).
On December 6, 2021, the FDA released a briefing document regarding Reata Pharmaceuticals, Inc's chronic kidney disease drug candidate, bardoxolone methyl. Therein, the FDA stated that the data submitted by Reata Pharmaceuticals, Inc did not "demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with [Alport syndrome]."
The plaintiff claims that between November 9, 2020 and December 8, 2021, the Defendants failed to disclose to investors 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 chronic kidney disease caused by Alport syndrome, that, as a result, there was a material risk that Reata's NDA would not be approved, and 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.
Those who purchased shares of Reata Pharmaceuticals, Inc. (NASDAQ: RETA) have certain options and should contact the Shareholders Foundation.
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