Aquestive Therapeutics, Inc. — Form 8-K
Filed September 25, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
Aquestive resubmitted its Anaphylm (dibutepinephrine) NDA to the FDA on September 17, 2026, addressing a Complete Response Letter issued January 30, 2026. The company has $98.5M cash (as of June 30, 2026), access to $75M from RTW Investments upon FDA approval, and $20M more from Oaktree Capital upon approval. Anaphylm projects $1B peak annual revenue; pipeline includes Libervant ($100M) and AQST-108 for atopic dermatitis ($500M). The company plans commercial launch in 2027 if approved and is pursuing international filings in Canada (before end of 2026) and the EU (Q1 2027).
Why this rating
NDA resubmission is material for $291.6M market-cap company; $1B peak-sales asset represents 3.4× annual revenue. Regulatory approval remains uncertain. Cash runway and conditional funding mitigate near-term liquidity risk but approval contingency limits certainty.
Tradability signal
NO TRADE
No trade: positive news with only -0.8% moved so far — good news prices in within seconds and long-side continuation has shown no measured edge (this cell: -0.84% over 4 hrs, n=128). (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 $4.88 ▲ 1.24% | at our read · unknown $4.82 | +10 min pending | +30 min pending | +1 hr pending | +4 hrs pending |
The stock had already moved -1.23% 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 September 25, 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.