Aquestive Therapeutics, Inc. — Form 8-K
Filed October 15, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
Aquestive announced the FDA accepted its NDA resubmission for Anaphylm (dibutepinephrine) sublingual film for anaphylaxis treatment as complete, classifying it as a Class 2 response with a PDUFA goal date of March 16, 2027. The resubmission was submitted September 16, 2026, following positive human factors and pharmacokinetic study results in August 2026 that addressed FDA's January 2026 Complete Response Letter concerns. Concurrently, the company remains on track to submit a Canadian New Drug Submission in Q4 2026.
Why this rating
Lead asset NDA resubmission accepted with 5-month review timeline; potential first-to-market oral epinephrine rescue drug. Represents material near-term value catalyst for $291.6M market cap company—regulatory approval would enable commercial launch of differentiated product in large anaphylaxis market.
Tradability signal
NO TRADE
No trade: positive news with only -0.3% moved so far — good news prices in within seconds and long-side continuation has shown no measured edge (this cell: +0.15% over 4 hrs, n=240). (Filing arrived outside market hours — evaluated at the next open with a live quote.)
Derived from this site's own measured outcomes + live price/liquidity at analysis time. An experiment, not investment advice.
Price action (we called it positive)
before filing · preread $4.67 ▲ 0.06% | at our read · unknown $4.67 | +10 min · unknown $4.61 ▼ 1.39% | +30 min · unknown $4.46 ▼ 4.39% | +1 hr · unknown $4.41 ▼ 5.67% | +4 hrs · unknown $4.17 ▼ 10.81% |
The stock had already moved -0.06% between hitting EDGAR and our read finishing — deltas above are measured from our read.
Quotes via Yahoo Finance at capture time; for filings arriving outside market hours the clock starts at the next open. Not investment advice. How accurate are our calls? →
See more from October 15, 2026.
EDGAR·FLOW summarizes public SEC EDGAR filings with automated analysis. Materiality scores and stock-impact predictions are algorithmically generated and are not investment advice. Always verify against the source filing on SEC.gov.