Articles from Filana Therapeutics, Inc.

Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy
AUSTIN, Texas, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing simufilam for the treatment of Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's investigational new drug (IND) application, enabling Filana to initiate a planned Phase 2a proof-of-concept study in patients aged 12 to 55 with TSC-related epilepsy. Patient screening is expected to begin by the first quarter of 2027.
By Filana Therapeutics, Inc. · Via GlobeNewswire · September 22, 2026
Filana Therapeutics Reports Q2 2026 Financial Results and Provides Business Update
AUSTIN, Texas, July 29, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2026 and provided a business update.
By Filana Therapeutics, Inc. · Via GlobeNewswire · July 29, 2026
Filana Therapeutics Reports Q1 2026 Financial Results and Business Update
AUSTIN, Texas, May 07, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the first quarter ended March 31, 2026 and provided a business update on the development of simufilam, an oral small molecule intended to modulate filamin A protein.
By Filana Therapeutics, Inc. · Via GlobeNewswire · May 7, 2026
Filana Therapeutics Presents TSC-Related Epilepsy Program at Eilat XVIII
Presentation described the biological rationale for the evaluation of simufilam in TSC-related epilepsy
By Filana Therapeutics, Inc. · Via GlobeNewswire · May 5, 2026
Filana Therapeutics Announces Publication in Epilepsia of Preclinical Simufilam Data
AUSTIN, Texas, April 15, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced publication in Epilepsia of preclinical data showing that simufilam attenuated seizure progression in a well-accepted mouse model of severe TSC-related epilepsy1. The results support the continued evaluation of simufilam for the treatment of TSC-related epilepsy, which affects approximately 45,000 people in the U.S.2,3. Simufilam is an oral small molecule intended to modulate filamin A protein.
By Filana Therapeutics, Inc. · Via GlobeNewswire · April 15, 2026
Filana Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
Working to advance TSC-related epilepsy program, with a focus on capital efficiency
By Filana Therapeutics, Inc. · Via GlobeNewswire · March 12, 2026
Cassava Sciences Announces Name Change to Filana Therapeutics, Inc.
New corporate identity reflects the Company’s mission to develop novel medicines to modulate filamin A and address unmet needs in treating TSC-related epilepsy
By Filana Therapeutics, Inc. · Via GlobeNewswire · March 10, 2026