The U.S. Department of Justice has concluded its investigation into Cassava Sciences regarding allegations of research misconduct related to its Alzheimer's drug, simufilam. This resolution is likely to enhance investor confidence and could positively impact SAVA's stock price.
Cassava Sciences received a full FDA clinical hold on simufilam trial. FDA requires additional pre-clinical data and protocol modifications. Clinical trial for TSC-related epilepsy now delayed beyond early 2026. Company reported $106.1 million cash to sustain operations until 2027. SAVA shares dropped 25.26% to $2.13 following the announcement.
Cassava's Phase 3 REFOCUS-ALZ study results were disappointing. Simufilam did not meet cognitive and functional endpoints. The drug development program for Alzheimer's will be terminated. Cassava plans to phase out the Alzheimer's program by Q2 2025. Stock declined 22.1%, reflecting market disappointment.