FDA Places Clinical Hold on Cassava’s Epilepsy Trial

The latest update is out from Cassava Sciences ( (SAVA) ).

On December 15, 2025, Cassava Sciences received a formal letter from the U.S. Food and Drug Administration placing a full clinical hold on its proposed proof-of-concept trial of simufilam in tuberous sclerosis complex-related epilepsy, pending additional information such as more pre-clinical data and protocol design changes. As a result, the company no longer expects to start the TSC-related epilepsy trial in the first half of 2026, and future timing will depend on how quickly it can satisfy the FDA’s requests and the completion of the agency’s review, potentially slowing its expansion into this indication and affecting development timelines for stakeholders.

The most recent analyst rating on (SAVA) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Cassava Sciences stock, see the SAVA Stock Forecast page.

Spark’s Take on SAVA Stock

According to Spark, TipRanks’ AI Analyst, SAVA is a Neutral.

Cassava Sciences faces significant financial challenges with no revenue and ongoing operational losses, reflected in the low financial performance score. Technical indicators show bearish trends, and the negative P/E ratio emphasizes valuation concerns. However, the strategic license agreement with Yale University could offer future growth potential, though it currently holds minimal weight due to its speculative nature.

To see Spark’s full report on SAVA stock, click here.

More about Cassava Sciences

Cassava Sciences is a biopharmaceutical company developing investigational drugs, including simufilam, with a focus on neurological and related conditions such as TSC-related epilepsy.

Average Trading Volume: 2,780,212

Technical Sentiment Signal: Sell

Current Market Cap: $141.5M

Find detailed analytics on SAVA stock on TipRanks’ Stock Analysis page.