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Truqap (supplemental) (capivasertib (Truqap) + abiraterone)

AstraZeneca · $AZN
Standard Review Breakthrough Therapy sNDA
PDUFA Date
June 30, 2026
Time Remaining
71 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 just now · 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

PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) — with abiraterone + ADT

Key Notes

sNDA 218197/S-004 under FDA review. PDUFA estimated ~June 30, 2026. ODAC review April 30, 2026 (PM session). Truqap already approved for HR+/HER2- breast cancer. CAPItello-281 Phase 3: capivasertib + abiraterone + ADT vs placebo + abiraterone + ADT in PTEN-deficient de novo mHSPC. Met primary endpoint with significantly improved rPFS (33.2 vs 25.7 months; HR 0.81; p=0.034). First biomarker-selected (PTEN deficiency) AKT inhibitor strategy in hormone-sensitive prostate cancer. Would expand Truqap into a second cancer indication.
⚠️ 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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