Reata investors may receive additional information about the case by clicking the link "Submit Your Information" above.
According to the complaint, Reata is a clinical stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways that regulate cellular metabolism and inflammation. Among Reata’s drug candidates under development is omaveloxolone, which is in Phase 2 clinical development to treat Friedreich’s ataxia (“FA”). Following the announcement of positive data from the MOXIe Part 2 study of omaveloxolone for FA in October 2019, Reata represented that it would seek submission for marketing approval of omaveloxolone for the treatment of FA in the U.S. with the U.S. Food and Drug Administration (“FDA”).
The Class Period commences on October 15, 2019. On October 14, 2019, during after-market hours, Reata issued a press release announcing positive topline results from the MOXIe Part 2 study of omaveloxolone for FA, and stating that Reata would seek marketing approval for omaveloxolone for treating FA in the U.S. based on those results. The press release quoted Reata’s Chief Executive Officer, J. Warren Huff, who represented, in relevant part, that “[t]he MOXIe trial with omaveloxolone is the first study to demonstrate a significant improvement in neurological function in patients with FA.”
The truth regarding omaveloxolone was revealed on August 10, 2020, during pre-market hours, when Reata issued a press release announcing its second quarter 2020 financial results. The press release disclosed that the FDA “is not convinced that the MOXIe Part 2 results” of Reata’s study assessing omaveloxolone for the treatment of FA “will support a single study approval without additional evidence that lends persuasiveness to the results,” and that, “[i]n preliminary comments for [a] meeting, the FDA stated that [Defendants] will need to conduct a second pivotal trial that confirms the mFARS results of the MOXIe Part 2 study with a similar magnitude of effect.”
Following this news, Reata’s stock price fell $51.79 per share, or 33.16%, to close at $104.41 per share on August 10, 2020.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (i) the MOXIe Part 2 study results were insufficient to support a single study marketing approval of omaveloxolone for the treatment of FA in the U.S. without additional evidence; (ii) as a result, it was foreseeable that the FDA would not accept marketing approval of omaveloxolone for the treatment of FA in the U.S. based on the MOXIe Part 2 study results; and (iii) as a result, Reata’s public statements were materially false and misleading at all relevant times.
If you are a member of the class described above, you may no later than December 14, 2020 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-844-887-9500 or 1-610-667-7706, or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.
CONTACT:
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq. or Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
1-844-887-9500 (toll free) or 1-610-667-7706
Or by e-mail at info@ktmc.com