Cassava Sciences Shares Fall After FDA Places Hold on Epilepsy Drug Trial
By Katherine Hamilton
Cassava Sciences shares fell after the company said the Food and Drug Administration had put a hold on its epilepsy drug trial.
The stock fell 15% to $2.41 in after-hours trading Thursday. Through the close, the stock had gained 21% this year.
The FDA has put a clinical hold on the Austin, Texas, pharmaceutical company's investigational new drug application and proposed clinical trial for simufilam.
Simufilam was going to be tested to treat tuberous sclerosis complex-related epilepsy.
The FDA is asking Cassava for additional information, including more pre-clinical data and modifications to the protocol design.
Cassava said it plans to address the items identified by the FDA, but no longer expects to initiate a clinical trial for simufilam in the first half of 2026, as it previously planned.
The updated timing for the trial will depend on whether Cassava can provide the information to the FDA's satisfaction, the company said.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
December 18, 2025 18:39 ET (23:39 GMT)
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