Compass Therapeutics, Inc. — Form 8-K
Filed September 22, 2026 · analyzed by the 8-K Agent
8-K
▼ Likely negative
significance 72/100
What the filing says
The FDA recommended Compass conduct a new trial demonstrating survival benefit before submitting a Biologics License Application for tovecimig in previously treated advanced biliary tract cancer, despite positive Phase 2/3 COMPANION-002 results showing statistically significant improvements in ORR (18.0% vs. 5.3%, p=0.0228) and PFS (median 4.7 vs. 2.6 months, HR 0.44, p<0.0001). Compass disagrees with the FDA requirement and intends to further engage with the agency, remaining confident in the data based on the 56% reduction in disease progression risk.
Why this rating
Regulatory setback requiring additional trial delays tovecimig BLA—major pipeline candidate for $277M company. Significant but not fatal given positive efficacy data and company's stated intent to re-engage FDA.
Tradability signal
SHORT
conviction 39/100 · expected -0.79% over 4 hrs
SHORT (drift): bad news keeps sliding after dissemination — our one persistent measured edge. Similar past filings (86 in this cell) moved +1.02% in the called direction over 4 hrs; shrunk for sample size that's a +0.79% edge. Price is down 31.3% since the filing hit EDGAR — the slide has begun. Caution: sub-$5 shorts can be hard to borrow — treat as avoid-longs if no locate. Exit plan: HARD stop 8% against entry — 1.4× this stock's measured hourly volatility, fixed, not trailing (trails test terribly on these names) — time exit 4 hrs. (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 negative)
before filing · preread $1.82 ▲ 30.00% | at our read · unknown $1.40 | +10 min · unknown $1.19 ▼ 14.71% | +30 min · unknown $1.34 ▼ 3.93% | +1 hr pending | +4 hrs pending |
The stock had already moved -23.08% 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 22, 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.