The FDA's decision date for taletrectinib is Jan 4, 2027, in 63 days. Nuvation's Quality Score is 0. Breakaway does the work for you: insider and Congress trades, the chart, and the financials, in one score. Scores as of 6:23 PM ET, 15 minutes behind.

Nuvation Bio (NUVB) · FDA decision date (PDUFA)

Nuvation's FDA decision on taletrectinib, a treatment for Non-small Cell Lung Cancer (NSCLC)

PDUFA dateJan 4in 63 days Quality Score0Below Average

Share price$4.59-3.57% on the day

As of 6:23 PM ET after-hours, delayed 15+ min · Live for Pro members

What the company said

“FDA had accepted a supplemental New Drug Application with updated data for IBTROZI in both TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC with a target action date of January 4, 2027.”

PDUFA date, Jan 4, 2027. As Nuvation Bio stated in its 10-Q of Aug 6, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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Kept by Andrew Gomes, Breakaway's founder, from the company's filings on the SEC's EDGAR and the drug's trials on ClinicalTrials.gov. Updated Nov 2, 2026.

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How to cite

Breakaway, Nuvation's FDA decision on taletrectinib, a treatment for Non-small Cell Lung Cancer (NSCLC), Nov 2, 2026, getbreakaway.com/biotech/NUVB-taletrectinib

Journalists: email support@getbreakaway.com for the data behind this page.

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