Filana Therapeutics reports news centered on its TSC-related epilepsy development program, simufilam, and the company’s transition from Cassava Sciences to the FLNA corporate identity. Recurring updates include financial results, business updates, scientific presentations, preclinical publications, and regulatory commentary related to the program’s FDA clinical hold.
Company news also covers the biological rationale for modulating filamin A, preclinical work in TSC-related epilepsy models, and corporate developments tied to governance, reporting, and Nasdaq trading under the FLNA symbol.
Filana Therapeutics (FLNA) announced publication in Cells of Yale researchers’ preclinical findings on simufilam in cells lacking the TSC2 gene. The study used engineered, kidney-derived human HEK293T cells to model cellular changes associated with tuberous sclerosis complex (TSC). Simufilam reduced elevated ATF4, a protein involved in cellular stress responses, by approximately 37% (p=0.03). It restored mitochondrial membrane potential, a measure of mitochondrial function, (p=0.007) and altered proteins associated with mitochondrial pathways.
Simufilam did not significantly suppress mTORC1, a signaling pathway involved in cell growth. Filana views the findings as support for continued investigation in TSC-related epilepsy and expects patient screening for its planned Phase 2a study by the first quarter of 2027. Clinical studies are needed to determine whether simufilam reduces seizures in patients.
Filana Therapeutics (FLNA) management will participate in the 2026 Maxim Growth Summit, held October 12–14, 2026, in New York. The conference format is one-on-one meetings, and the venue is The Hard Rock Hotel NYC.
Filana Therapeutics (FLNA) reported that the FDA has lifted the clinical hold on its IND for simufilam, allowing initiation of a planned Phase 2a proof-of-concept trial in patients aged 12 to 55 with TSC-related epilepsy.
The 16-week, multicenter, randomized, double-blind study will evaluate two doses of simufilam in approximately 40 patients across 13 U.S. sites, with all completers eligible for a 48-week extension study. Patient screening is expected to begin by the first quarter of 2027. The trial will assess safety, tolerability, pharmacokinetics, and multiple seizure-related and sleep outcomes, and is expected to inform future development, including in younger patients.
Simufilam, an oral small molecule that targets filamin A, is supported by preclinical mouse data showing reduced seizure frequency and dose-dependent attenuation of seizure progression in TSC-related models, under an exclusive worldwide license from Yale University.
Filana Therapeutics (NASDAQ: FLNA) reported Q2 2026 cash and cash equivalents of $82.7 million, down from $95.5 million at December 31, 2025, with no debt. Q2 net loss was $8.6 million, or $0.18 per share, versus a $44.2 million loss, or $0.92 per share, in Q2 2025.
Q2 2026 R&D expenses were $3.3 million, down 35% year over year due to the completed phase-out of the Alzheimer’s program, while G&A expenses fell 85% to $6.1 million, largely reflecting a $31.25 million securities litigation loss contingency recorded in Q2 2025 not repeating.
According to Filana Therapeutics, it paid $31.25 million into escrow on July 23, 2026 toward a potential settlement of certain securities litigation, which remains restricted pending final court approval. Net cash used in operations was $12.7 million in first-half 2026, below prior guidance, with second-half operating cash use expected at $11–$15 million plus the settlement funding. The company estimates unrestricted year-end 2026 cash of $36–$40 million and continues to work with the FDA to address the clinical hold on its TSC-related epilepsy trial.
Filana Therapeutics (NASDAQ: FLNA) reported Q1 2026 results and a business update on simufilam for TSC-related epilepsy on May 7, 2026. Cash was $86.6M at March 31, 2026; estimated cash at June 30, 2026 is $47–$50M. Net loss was $10.3M ($0.21/share); R&D and G&A declined year-over-year.
The company is addressing the FDA clinical hold with additional preclinical data and protocol changes and presented preclinical simufilam data at Eilat XVIII and in Epilepsia.
Filana Therapeutics (NASDAQ: FLNA) presented its biological rationale for evaluating simufilam in TSC-related epilepsy at Eilat XVIII in Madrid on May 5, 2026. The presentation covered the scientific and clinical rationale for the company’s program. Management said it is focused on addressing the clinical hold and will provide updates as available.
Filana Therapeutics (NASDAQ: FLNA) announced publication in Epilepsia (online Apr 14, 2026) of preclinical data showing that oral simufilam dose‑dependently attenuated seizure progression in the Tsc1‑cKO mouse, a severe model of TSC‑related epilepsy. The study reported a statistically significant correlation between dose and seizure counts and supports continued evaluation while the company works to resolve an FDA clinical hold.
Filana Therapeutics (NASDAQ: FLNA) reported 2025 results and a business update focused on its TSC-related epilepsy program and capital efficiency.
The company posted a net loss of $91.0 million ($1.88 per share) for 2025, year-end cash of $95.5 million and estimates cash of $47–$50 million at June 30, 2026. Filana is addressing FDA requests tied to a December 2025 clinical hold and expects to submit a response as soon as practicable.
Filana Therapeutics (NASDAQ: FLNA) is the new corporate name formerly known as Cassava Sciences, effective March 11, 2026.
The rebranding aligns the company with its strategic focus on developing medicines that modulate the filamin A protein to address CNS disorders, including Tuberous Sclerosis Complex-related epilepsy. The updated website is available at https://www.filanatx.com.