Articles from Filana Therapeutics, Inc.

Appointment brings leadership experience building and financing biopharma companies

– Patient screening in Phase 2a study of simufilam in TSC-related epilepsy expected to begin by Q1 2027, following recent lift of FDA clinical hold

Findings provide new insight into simufilam’s effects on cellular stress responses and mitochondrial function

AUSTIN, Texas, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, "Filana Therapeutics", the "Company"), a biotechnology company currently focused on developing therapies for the treatment of Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced that the Company’s management team will participate in the 2026 Maxim Growth Summit being held October 12-14, 2026 in New York.

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.

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.

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.

Presentation described the biological rationale for the evaluation of simufilam in TSC-related epilepsy

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.

Working to advance TSC-related epilepsy program, with a focus on capital efficiency

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