On September 17, Nasdaq warned Filana Therapeutics its shares had spent a month below the exchange's minimum price. Five days later, the FDA lifted the block on its main drug program.
The FDA cleared the company to advance simufilam toward a mid-stage human trial targeting tuberous sclerosis complex — TSC, a rare genetic condition that causes seizures in 80% to 90% of the people it affects, according to the company's September 22 announcement. Simufilam is an oral drug designed to act on a protein called filamin A. The case for it rests on animal studies; no human efficacy data exist yet.
Shares closed 39.28% higher at $1.0300 on September 23, after the announcement, on dollar volume of about $100 million across 186,415 trades.
For anyone holding the stock, the two events pull in opposite directions. The FDA news clears a regulatory obstacle that had stopped the trial program from moving forward. The Nasdaq notice starts a clock: to stay listed, the stock must close above $1.00 for at least ten consecutive business days before March 16, 2027. That deadline arrived because the shares had closed below that floor for thirty consecutive business days — a count the September 23 close has started, but not yet resolved.
The company says it completed trial-readiness work while the hold was in place, including engaging a clinical research organization and identifying sites. The planned study is a 16-week trial at 13 sites in the U.S., targeting 40 participants aged 12 to 55 whose seizures have not responded to existing treatments. Those who complete it are eligible for a 48-week follow-on study.
Patient screening is expected to start by the first quarter of 2027. The Nasdaq compliance window runs to the same month.