FDA placed a clinical hold on the proposed proof-of-concept clinical trial for Simufilam in tuberous sclerosis complex -related epilepsy earlier this week.
- Cassava said that it intends to work “expeditiously” with the FDA and address the items flagged by the agency.
- The company added that it no longer expects to initiate the trial in question in the first half of 2026.
- Cassava discontinued Simufilam’s study in mild-to-moderate Alzheimer’s disease in March.
Shares of Cassava Sciences, Inc.’s slid a deep 24% on Friday after the U.S. Food and Drug Administration placed a full clinical hold on the proposed proof-of-concept clinical trial for Simufilam in tuberous sclerosis complex -related epilepsy.
The stock is now on track for its worst day in about 9 months.
The company was informed by the FDA of the hold in a letter earlier this week, it said in a filing with the Securities and Exchanges Commission. The company now has to provide the agency with additional information, including additional pre-clinical data, and modify the protocol design.
Cassava said that it intends to work “expeditiously” with the FDA and address the items flagged by the agency. The company added that it no longer expects to initiate the trial in question in the first half of 2026.
The company failed to provide a new timing for the study, and said it would depend on its ability to provide the requested information and on satisfactory completion of FDA’s review.
Cassava Hits Multiple Roadblocks With Simufilam
Cassava discontinued Simufilam’s study in mild-to-moderate Alzheimer’s disease in March after the drug did not fare better than placebo in reducing cognitive or functional decline in a late-stage study. The company discontinued its efforts to develop the drug for Alzheimer’s disease and phased out the program and then committed to evaluating the drug’s potential in TSC-related epilepsy.
Tuberous Sclerosis Complex (TSC) is a rare genetic disorder causing non-cancerous tumors (hamartomas) to grow in many organs, primarily the brain, skin, kidneys, heart, lungs, and eyes. It can lead to symptoms including seizures, developmental delays, intellectual disabilities, and skin abnormalities.
According to Austin-based Cassava, TSC affects nearly 50,000 people in the US and epilepsy is one of the most common neurological features of TSC, occurring in 84% of patients. Current therapies for the condition include antiepileptic drugs and mTOR inhibitors which are not fully effective, and are associated with serious adverse events, the company said in November.
Cassava decided to study Simufilam in TSC-related epilepsy on the results of two sophisticated studies conducted in animals that support the drug’s potential, CEO Rick Barry said last month.
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