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# The FDA Unblocked This Drug Trial. Nasdaq May Delist the Company Anyway.
- URL: https://www.pennystocks.news/flna-the-fda-unblocked-this-drug-trial-nasdaq-may-delist-the/
- Published: 2026-09-23T16:20:34.000Z
- Updated: 2026-09-23T16:20:34.000Z
- Description: The FDA cleared Filana's simufilam program to advance to a human trial five days after Nasdaq put the company on notice for trading too low. Both clocks now run to early 2027.
- Author: PennyStocksNews Team
- Tags: nasdaq, ticker-flna

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**.

Filana Therapeutics, Inc. NASDAQ: FLNA 

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.