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Enhertu + Perjeta (fam-trastuzumab deruxtecan-nxki + pertuzumab)

AstraZeneca / Roche · $AZN
Priority Review Breakthrough Therapy sBLA
PDUFA Date
January 20, 2026
Date Status
119d ago (past)
Review Type
Priority (6 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

FDA Decision

✅
✓ FDA Approved
Decision issued: December 15, 2025
FDA Approved on 2025-12-15 (BLA761139). Source: FDA Drugs@FDA database.
Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139

Live Company Data NYQ

Updated 4m ago · Data: FMP
Current Price
$183.92 +33.64%
+$46.30 today
Day: $182.69 – $184.74
Market Cap
N/A
52-Week Range
$137.22
$212.71
Current price is at 62% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

First-line HER2-positive metastatic breast cancer (combination)

Key Notes

Supplemental BLA for Enhertu + pertuzumab combination in HER2+ metastatic breast cancer. Approved by FDA January 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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