FDA Puts Cassava's Simufilam Epilepsy Trial On Full Clinical Hold

benzinga_article
2025.12.19 16:31
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Cassava Sciences confirmed that the FDA has placed a full clinical hold on its simufilam epilepsy trial, requiring additional data and protocol modifications. This delay means the trial will not start in the first half of 2026 as planned. The company has $106.1 million in cash reserves, expected to support operations into 2027. Cassava also reported that its Phase 3 Alzheimer's trial for simufilam did not meet key endpoints, leading to discontinuation. Shares fell 25.26% to $2.13.