CG Oncology: Vast Majority of Events in Hand for P6; 2Q Key Takes

研报英文原文证据摘录

J P M O R G A N

North America Equity Research

06 August 2026

CG Oncology

Vast Majority of Events in Hand for P6; 2Q Key Takes

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CGON, CGON US

Price (05 Aug 26):$72.42

SMid Biotechnology

This morning, we caught up with CGON’s CEO following the 2Q print

released before market open. The bottom line, creto’s intermediate-risk PIVOT6’s top line is now expected near term as the rolling BLA for the BCG-UNR setting

is on track to complete in 4Q (see our dinner note here).

From our follow-up, CGON has accrued the vast majority of the target number

of events for the topline. Mgmt indicated that the recently updated primary

completion date (now Nov) may not be a reliable indicator for the timing of the

topline. As a reminder, we continue to see the bar for success of the P6 trial as

near the low 0.6-handle for RFS HR and 70%-80% for RFS at Month 12-15

(see our preview 1.0, 2.0). On the BLA front, a combined initial HR BCG UNR and

IR filing appears unlikely, in our view. Mgmt noted that the BCG-UNR setting is

associated with the breakthrough designation, but not the IR setting. Beyond these

items, mgmt discussed their plans to advance development in the BCG-exposed

setting and expects to provide additional data from CORE-008 Cohort CX (creto

+ gem) later this year. Reiterate OW.