MRK PDUFA Date: Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab)
FDA decision (PDUFA) target 2026-12-31 · Merck & Company Inc. · Inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC)
MRK run-up into the PDUFA (last ~120 days)
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.
Key facts
FDA PDUFA target date2026-12-31
Drug / candidateTrodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab)
IndicationInoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC)
The FDA PDUFA target date for MRK (Merck & Company Inc.) is 2026-12-31 for Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is MRK's drug Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab)?
Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) is Merck & Company Inc.'s candidate under FDA review for Inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.