Cassava investors may receive additional information about the case by clicking the link "Submit Your Information" above. If you are a member of the class described above, you may no later than October 26, 2021 move the Court to serve as lead plaintiff of the class, if you so choose.
Cassava is a clinical stage biotechnology company. Its lead therapeutic product candidate is called simufilam (formerly PTI-125) developed as a treatment for Alzheimer’s disease (“AD”). Simufilam purportedly targets an altered form of a protein called filamin A (“FLNA”) in the Alzheimer’s brain and reverts it to its native, healthy conformation, thereby countering the downstream toxic effects of altered FLNA.
The Class Period commences on September 14, 2020, when Cassava announced the final results from its Phase 2b clinical study of simufilam in a press release that stated, in relevant part, that “simufilam significantly improved an entire panel of validated biomarkers of disease in patients with Alzheimer’s disease.”
The truth regarding simufilam began to emerge after the close of trading on August 24, 2021, when it was disclosed that the U.S. Food and Drug Administration (“FDA”) had received a so-called Citizen Petition commencing an administrative action to “halt two ongoing trials of the drug Simufilam . . . pending a thorough audit by the FDA.” As detailed in the Citizen Petition, “[i]nformation available to the petitioner . . . raises grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy.”
Then, on August 25, 2021, before the market opened, Cassava issued a response to the Citizen Petition, claiming that the allegations regarding scientific integrity are false and misleading. Among other things, Cassava claimed that the clinical data, which the Citizen Petition stated had been reanalyzed to show simufilam was effective, had been generated by Quanterix Corp. (“Quanterix”), an independent company, suggesting that the reanalysis was valid. Following this news, Cassava’s share price fell $36.97, or 32%, to close at $80.86 per share on August 25, 2021.
Finally, on August 27, 2021, before the market opened, Quanterix issued a statement denying Cassava’s claims, stating that it “did not interpret the test results or prepare the data” touted by Cassava. That same day, Cassava responded to Quanterix’s statement, stating that “Quanterix’[s] sole responsibility with regard to this clinical study was to perform sample testing, specifically, to measure levels of p-tau in plasma samples collected from study subjects.” Following this news, Cassava’s share price fell $12.51, or 17.6%, to close at $58.34 per share on August 27, 2021.
The complaint alleges that throughout the Class Period, the defendants failed to disclose to investors that: (1) data underlying the foundational research for Cassava’s product candidates had been manipulated; (2) experiments using post-mortem human brain tissue frozen for nearly 10 years was contrary to a basic understanding of neurobiology; (3) biomarker analysis for patients treated with simufilam had been manipulated to conclude that simufilam was effective; (4) Quanterix, an independent company, had not interpreted the test results or prepared the data charts for the biomarker analysis for patients treated with simufilam; (5) as a result of the foregoing, there was a reasonable likelihood that Cassava would face regulatory scrutiny in connection with the development of simufilam; and (6) as a result of the foregoing, the defendants’ positive statements about Cassava’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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.
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: James Maro, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at firstname.lastname@example.org. 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.