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Live Company Data
NYQ
Updated
1m ago
· Data: FMP
Current Price
$193.88
+31.37%
+$46.30 today
Day: $192.61 – $194.64
52-Week Range
Current price is at 79% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Indication
HR+/HER2- advanced breast cancer — 1L with emergent ESR1 mutation (with CDK4/6 inhibitor)
Key Notes
NDA 220359 under FDA review. PDUFA estimated ~June 30, 2026 (10-month standard review from ~August 2025 filing). ODAC review April 30, 2026 (AM session). SERENA-6 Phase 3: switching to camizestrant + CDK4/6i at ESR1 mutation emergence (before progression) reduced risk of disease progression/death by 56% (p<0.001). Novel mid-treatment "switch" design to intercept ESR1 resistance — potential new standard of care paradigm for 1-in-3 HR+ advanced breast cancer patients who develop ESR1 mutations during first-line treatment.
⚠️ 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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