Filana Therapeutics still under FDA clinical hold on simufilam trial, reports Q2 2026 results

Filana Therapeutics reported on July 29, 2026 that its proof-of-concept trial of simufilam in TSC-related epilepsy remains under a clinical hold. Chief Executive Officer Rick Barry said the company continues to engage with the FDA on the hold and is working to address the agency's request for information so it can be lifted.¹ Barry said participation in the TSC World Conference this week would keep the company connected to the community and prepared for future development of simufilam as the regulatory process continues.¹

On the community engagement front, Filana is sponsoring the "2026 TSC World Conference," an event hosted by the TSC Alliance and Tuberous Sclerosis Complex International (TSCi) running July 30 to August 1, 2026, in Aurora, Colorado.¹ Separately, peer-reviewed proceedings from the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices were published in Epilepsia, including a summary of the biological rationale and preclinical data behind the simufilam program consistent with the presentation Filana gave in Madrid on May 5, 2026.¹

On finances, cash and cash equivalents at June 30, 2026 were $82.7 million, down from $95.5 million at the end of 2025.¹ Net cash used in operations was $12.7 million during the first half of 2026, below previous guidance.¹ The company expects net cash used in operations for the second half of 2026 to run $11 million to $15 million, plus a separately funded $31.25 million litigation settlement payment, and estimates unrestricted cash at year-end 2026 of $36 million to $40 million.¹ On July 23, 2026, Filana paid $31.25 million into escrow tied to a potential securities litigation settlement, a step toward final resolution pending court approval.¹