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zidesamtinib (NVL-520)

Nuvalent · $NUVL
Priority Review Breakthrough Therapy NDA
PDUFA Date
September 18, 2026
Time Remaining
72 days
Review Type
Priority (6 mo)
90%
Baseline PoA
NDA priority review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$123.78 +57.15%
+$45.02 today
Day: $123.74 – $123.85
Market Cap
N/A
52-Week Range
$71.13
$123.85
Current price is at 100% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

TKI-pretreated advanced ROS1-positive non-small cell lung cancer (NSCLC)

Key Notes

FDA accepted the NDA with Priority Review and a PDUFA target action date of September 18, 2026. Brain-penetrant, ROS1-selective inhibitor designed to spare TRK and reduce related toxicity, supported by the ARROS-1 pivotal trial. Nuvalent lead program alongside neladalkib (ALK, PDUFA November 27, 2026). Source: Nuvalent 8-K and IR (NDA acceptance 2026).
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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