Cassava Sciences has settled SEC charges related to misleading statements about its Alzheimer’s drug, simufilam. The company paid $40 million and is now focusing on the drug’s development. HC Wainwright upgraded Cassava’s stock to ‘Buy’ due to positive expectations for the upcoming clinical trial results.
Cassava Sciences, its founder, and former executives have agreed to pay over $40 million to settle SEC charges alleging they misled investors about the results of a Phase 2 trial for their Alzheimer’s drug, simufilam. The SEC found that the company manipulated trial data to falsely suggest the drug’s effectiveness. The settlement includes penalties and bans on serving as officers or directors for certain individuals.
Cassava Sciences has announced that its Alzheimer’s drug candidate, simufilam, has successfully passed an interim safety review, allowing its ongoing Phase 3 trials to continue without changes. The Data and Safety Monitoring Board (DSMB) reviewed patient safety data from the trials and recommended no modifications. Simufilam is a novel oral drug designed to treat Alzheimer’s disease. The two Phase 3 trials, fully enrolled with over 1,900 patients, are expected to yield top-line results by the end of 2024 and mid-2025.
