Filana clears FDA hold, sets early 2027 start for TSC epilepsy trial screening
Filana Therapeutics said patient screening for its Phase 2a simufilam study in TSC-related epilepsy is expected to begin by the first quarter of 2027 after the FDA lifted a clinical hold in September 2026.
Filana Therapeutics reported on November 5, 2026 that the FDA lifted a clinical hold on its investigational new drug application for simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy in September 2026.1 Following that decision, the company is advancing preparations for its planned Phase 2a study.1
The study is expected to be sizable and multi-site: it is expected to enroll approximately 40 patients ages 12 to 55 at approximately 13 clinical sites in the United States.1 It will be a randomized, double-blind study evaluating two doses of simufilam added to standard of care therapy, consisting of a four-week baseline assessment, a 16-week treatment period, and an optional 48-week extension.1 Patient screening is expected to begin by the first quarter of 2027.1
Filana also cited new preclinical data: an October publication by researchers at Yale School of Medicine, in the journal Cells, evaluated simufilam in TSC2-deficient human cells and identified effects on cellular stress-related signaling and mitochondrial function.1
On financials, cash and cash equivalents at September 30, 2026 were $47.0 million,1 and the company has no debt.1 On July 23, 2026, the company transferred $31.25 million into escrow in connection with the potential settlement of certain securities litigation recorded in 2025.1
Looking ahead, net cash used in operations for the second half of 2026 is expected to be in a range from $11 to $15 million, and the company estimates cash and cash equivalents at year-end 2026 in a range from $38 to $42 million.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.