Law Offices of Howard G. Smith continues its investigation on behalf of Reata Pharmaceuticals, Inc. (“Reata” or the “Company”) (NASDAQ: RETA) investors concerning the Company’s possible violations of federal securities laws.
On November 9, 2020, Reata announced that its Phase 3 CARDINAL study of bardoxolone in patients with chronic kidney disease by Alport syndrome “met its primary and key secondary endpoints at the end of Year 2.” Due to these results and “a recently completed pre-NDA meeting with the [FDA],” the Company planned to submit its NDA in the first quarter of 2021.
Then, 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 in 2020 the FDA had “voiced concerns about the interpretability of the eGFR findings given the available information on the time course for resolution of bardoxolone’s pharmacodynamic effect, as well as the amount of missing data in the bardoxolone arm.” The agency also questioned whether the Phase 3 study was adequately designed to assess the effectiveness of bardoxolone.
On this news, the Company’s stock price fell $29.77, or 38%, to close at $48.92 per share on December 6, 2021, thereby injuring investors.
Then, on December 8, 2021, the FDA’s Advisory Committee unanimously decided that bardoxolone was not effective.
On this news, the Company’s stock price fell $25.31, or 46%, to close at $29.11 per share on December 9, 2021, thereby injuring investors further.
If you purchased Reata securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
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Law Offices of Howard G. Smith
Howard G. Smith, Esquire