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Truqap (capivasertib (Truqap) + abiraterone (sNDA 218197/S-004))

AstraZeneca · $AZN
Standard Review Advisory Committee ODAC
AdCom Date
April 30, 2026
Time Remaining
30 days
Review Type
Standard (10 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NYQ

Updated 1m ago · Data: FMP
Current Price
$193.88 +31.37%
+$46.30 today
Day: $192.61 – $194.64
Market Cap
N/A
52-Week Range
$122.48
$212.71
Current price is at 79% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

Indication

PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC)

Key Notes

ODAC (Oncologic Drugs Advisory Committee) meeting April 30, 2026 — AFTERNOON SESSION. Committee will review sNDA 218197/S-004 for Truqap (capivasertib) in combination with abiraterone acetate (Zytiga) for PTEN-deficient de novo mHSPC. CAPItello-281 Phase 3 met primary rPFS endpoint (33.2 vs 25.7 months; HR 0.81; p=0.034). First AKT inhibitor sNDA for prostate cancer. Truqap is already approved for HR+ breast cancer. PDUFA estimated June-July 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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