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camizestrant (NDA 220359)

AstraZeneca · $AZN
Standard Review Advisory Committee ODAC
AdCom Date
April 30, 2026
Time Remaining
10 days
Review Type
Standard (10 mo)
85%
Baseline PoA
NDA standard review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NYQ

Updated 4m ago · Data: FMP
Current Price
$204.80 +51.50%
+$69.62 today
Day: $202.55 – $205.30
Market Cap
N/A
Shares out: 1.55B
Float: 1.54B
52-Week Range
$132.32
$212.71
Current price is at 90% of 52-week range
Avg Volume
2.28M
Beta
0.28
vs. S&P 500
Sector
Healthcare
Drug Manufacturers - General
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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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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