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NYQ
Updated
3m 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 — first-line with emergent ESR1 mutation
Key Notes
ODAC (Oncologic Drugs Advisory Committee) meeting April 30, 2026 — MORNING SESSION. First FDA cancer AdCom in roughly 9 months, ending a drought since July 2025. Committee will weigh NDA 220359 for camizestrant tablets in combination with a CDK4/6 inhibitor for 1L HR+/HER2- advanced breast cancer with emergent ESR1 mutation (SERENA-6 data). The novel "switch" trial design — enrolling mid-CDK4/6i treatment at ESR1 mutation emergence rather than at progression — is likely the key discussion point. PDUFA estimated June 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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