Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✕ COMPLETE RESPONSE LETTER
MacroGenics Inc., ZYNYZ (retifanlimab-dlwr) · Non-small cell lung cancer (NSCLC).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (10/22/25) through T+5. Run-up high $3.43 on 3/11/26, low $1.33 on 12/15/25 (T-120 to T-1). FDA decision 4/8/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-04-08
OutcomeCRL
Drug / candidateZYNYZ (retifanlimab-dlwr) - (POD1UM-304)
CompanyMacroGenics Inc.
120-day run-up (T-120→T-1)+108.1%
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Specialist biotech funds holding MGNX, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was ZYNYZ (retifanlimab-dlwr) approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for ZYNYZ (retifanlimab-dlwr) in its current form, was announced on April 8, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind ZYNYZ (retifanlimab-dlwr)?
ZYNYZ (retifanlimab-dlwr) is a MacroGenics Inc. (MGNX) program. The company announced the FDA decision on April 8, 2026; the primary source is linked on this page.
How did MGNX stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), MGNX moved +108.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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