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NUVB PDUFA Date: IBTROZI

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FDA decision (PDUFA) target Jan 4, 2027 · Nuvation Bio Inc. · ROS1-positive non-small cell lung cancer

Key facts

FDA PDUFA target date2027-01-04
Drug / candidateIBTROZI (taletrectinib)
IndicationROS1-positive non-small cell lung cancer
CompanyNuvation Bio Inc.
Market-cap tierMid

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FAQ

When is the NUVB PDUFA date?
The FDA PDUFA target date for NUVB (Nuvation Bio Inc.) is 2027-01-04 for IBTROZI (taletrectinib). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is NUVB's drug IBTROZI?
IBTROZI (taletrectinib) is Nuvation Bio Inc.'s candidate under FDA review for ROS1-positive non-small cell lung cancer.