Investigation of Cassava Sciences, Inc.

Cassava Sciences, Inc. (SAVA) Accused of Falsely Touting the Viability and Efficacy of its Lead Drug Candidate    

A class action was filed on behalf of all persons and entities that purchased or otherwise acquired Cassava Sciences, Inc. (NASDAQ:SAVA) securities between February 2, 2021 and August 24, 2021, for violations of the Securities Exchange Act of 1934.  Cassava is a biotechnology company engaged in the development of drugs for neurodegenerative diseases.  Its lead therapeutic product candidate is simufilam, a small molecule drug designed to treat Alzheimer’s disease.

According to the complaint, on February 2, 2021, Cassava announced results from its interim analysis of an open-label study of simufilam, which purportedly demonstrated that patients’ cognition and behavior scores both improved following six months of simufilam treatment, with no safety issues. According to the Company, “[i]n a clinical study funded by the National Institutes of Health and conducted by Cassava Sciences, six months of simufilam treatment improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6,” and “[i]n these same patients, simufilam also improved dementia related behavior, such as anxiety, delusions and agitation, by 1.3 points on the Neuropsychiatric Inventory, a 29% mean improvement from baseline to month 6.”  Cassava continued to tout the viability of simufilam throughout the class period. 

Then, on August 24, 2021, it was disclosed that the U.S. Drug and Food Administration had received a Citizen Petition commencing an administrative action to “halt two ongoing trials of the drug SImufilam … pending a thorough audit by the FDA.”  The Petition detailed “grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy.”  The Petition concluded that there are “compelling grounds for pausing the ongoing clinical trials until the FDA can conduct and complete a rigorous audit of Cassava’s research.”  On this news, the price of Cassava’s stock fell $37.00, or 32%. The stock has yet to recover.


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