Cassava Sciences

The U.S. Department of Justice has closed its investigation of Cassava Sciences related to alleged research misconduct over the experimental Alzheimer’s drug simufilam, four months after a related criminal indictment was dismissed. Cassava halted simufilam’s Alzheimer’s development last year after disappointing trial results. The company previously settled SEC charges over misleading trial claims with a monetary penalty, and is now developing simufilam for tuberous sclerosis complex–related epilepsy. » More on finance.yahoo.com

The phase‑3 trials RETHINK‑ALZ and REFOCUS‑ALZ, published in the Journal of Prevention of Alzheimer’s Disease, failed to meet both co‑primary and secondary endpoints, leading Cassava to halt Alzheimer’s development of simufilam. The company now plans a phase‑2 proof‑of‑concept study of simufilam in epilepsy related to tuberous sclerosis. Cassava recently reported heavy cash burn and a net loss of USD 106 million over 12 months, and market capitalization fell to about USD 102.4 million; however, the balance sheet shows a current ratio of 2.27. Exploratory post‑hoc analyses showed short‑term signals of efficacy in subgroups but were not consistently replicated. » More on de.investing.com

Cassava Sciences and CFO Eric J. Schoen agreed to pay $31.25 million to resolve a consolidated securities class action covering the period Sept. 14, 2020 to Oct. 12, 2023. The payment is to be deposited into a trust account in January 2026 and, after final court approval, will result in releases for the named executives; the company emphasizes it is not admitting wrongdoing. At the same time, the FDA has imposed a full clinical hold on the simufilam study and is requiring additional preclinical data and protocol changes, delaying the start of the trials. » More on de.investing.com

The FDA has fully suspended the planned clinical trial of Simufilam for epilepsy associated with tuberous sclerosis complex and is requesting additional information including preclinical data and adjustments to the study design. In response, Cassava Sciences' stock fell 13.3%. The company says it will promptly address the requested items but no longer expects the trial to start in the first half of 2026; a new timeline depends on the submission of documents and the FDA’s review. » More on de.investing.com

Cassava Sciences' stock fell about 13% in early U.S. trading after the FDA requested additional data to assess the safety risks of the drug candidate Simufilam. Simufilam is intended for epilepsy associated with tuberous sclerosis complex; the application was meant to support a planned proof-of-concept study. Cassava expects an official letter from the FDA, says it will cooperate, and remains committed to starting the study in the first half of 2026. » More on de.investing.com