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FDA Calendar - Nuvalent, Inc.

Company Name Nuvalent, Inc.
NUVL
Drug Name Zidesamtinib (NDA)
Event Name FDA decision on Zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least 1 prior ROS1 tyrosine kinase inhibitor
Event Date 09/18/2026
Outcome Date
Outcome Pending
Drug Status
Rival Drugs Roche’s Rozlytrek; Pfizer's Xalkori, and Bristol Myers Squibb's Augtyro, to name a few
Market Potential
Other Approvals
News
Nuvalent's NDA For Zidesamtinib In ROS1-Positive NSCLC Accepted By FDA
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