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· 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
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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