Filana Therapeutics

Develops simufilam, an oral small molecule being investigated for TSC-related epilepsy and other possible central-nervous-system indications involving filamin A. This Austin-based clinical-stage biotechnology business centers on a single named candidate and has no approved products or product-sales revenue. Its stated mission is to develop therapies for CNS disorders involving dysregulation or overexpression of filamin A.

Current development follows a pivot away from the discontinued Alzheimer's program. The proposed proof-of-concept TSC-related-epilepsy trial remains on full FDA clinical hold while Filana addresses additional preclinical-information and protocol-modification requests. Advancing the program depends on FDA review, clinical development, regulatory approval, manufacturing supply, and commercialization capabilities.