Cassava Sciences Inc. (NASDAQ:SAVA) received a formal letter from the U.S. Food and Drug Administration (FDA) related to the company’s trial for simufilam
Following previously reported communications with the FDA regarding Cassava’s investigational new drug application and proposed proof-of-concept clinical trial for simufilam in tuberous sclerosis complex (TSC)-related epilepsy, the company confirmed a full FDA clinical hold.
The SEC filing highlighted that the company has to provide the FDA with additional information, including additional pre-clinical data, and modify the protocol design.
Cassava intends to work to address the items identified in the letter.
However, the company no longer expects to initiate a proof-of-concept clinical trial for simufilam in TSC-related epilepsy in the first half of 2026 as previously disclosed.
The updated timing for initiation of a clinical trial will depend on the company’s ability to provide the requested information and on satisfactory completion of the FDA’s review.
The company reported $106.1 million in cash and cash equivalents at September 30, 2025. Expected to support operations into 2027.
What’s Next For Simufilam After This Delay?
In March, Cassava Sciences shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease.
Topline data indicate that REFOCUS-ALZ did not meet each of the prespecified co-primary, secondary, and exploratory biomarker endpoints.
Cassava discontinued developing simufilam for Alzheimer’s disease.
SAVA Price Action: Cassava Sciences shares were down 25.26% at $2.13 at the time of publication on Friday, according to Benzinga Pro data.
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