Filana Therapeutics Inc. (FLNA), a biotechnology company, delivered a scientific presentation outlining the biological rationale for its clinical development program for Simufilam in treating tuberous sclerosis complex-related epilepsy, at the eighteenth Eilat conference on new antiepileptic drugs and devices.
Following the announcement, shares fell to a 52-week low at $1.38.
Tuberous sclerosis complex (TSC) is a rare, genetic disorder caused by mutations on the TSC1 and TSC2 genes. This affects the mechanistic target of rapamycin (mTOR) pathway, leading to the formation of tumors. 80%-90% of TSC patients experience seizures, and over 60% of these remain refractory to existing anti-epileptic medications.
Simufilam is a novel, investigational drug designed to modulate the filamin A protein. The dysregulation of filamin A causes many disorders of the central nervous system (CNS), including TSC.
The company cited ongoing efforts to address the previously disclosed request for information contained in a Clinical Hold Letter from the U.S. FDA in December 2025. It intends to submit additional preclinical data and protocol design modifications to facilitate a response to the FDA.
Program updates are expected to be provided in the following months.
FLNA is currently trading at $1.40, up 1.36%.
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