Cassava Sciences Stock Plummets 85% After Phase III Study Failure
Cassava Sciences announced on November 25, 2024, that its Phase III ReThink-ALZ study failed to meet primary and secondary endpoints for treating mild to moderate Alzheimer's disease. The trial results indicated that Simufilam did not show superiority over a placebo in improving ADAS-COG12 and ADCS-ADL scores. This news led to an 85% drop in the company’s stock price. Since 2021, the efficacy of Simufilam in reducing β-amyloid protein toxicity has been questioned. Two scientists petitioned the FDA to suspend the trials, citing image manipulation in research papers. An NIH investigation report accused the developers of academic misconduct in multiple publications. FDA reviews found issues with data handling, including improper equipment calibration and inappropriate statistical testing. The researchers were indicted by the DOJ in June 2023 for allegedly defrauding NIH grants of approximately $16 million.
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