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vepdegestrant (ARV-471)

Arvinas / Pfizer · $ARVN
Standard Review Fast Track NDA
PDUFA Date
June 5, 2026
Time Remaining
66 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 NMS

Updated 6m ago · Data: FMP
Current Price
$10.18 +34.12%
+$2.59 today
Day: $10.00 – $10.33
Market Cap
N/A
52-Week Range
$5.90
$14.51
Current price is at 50% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

Indication

ESR1-mutated ER+/HER2- advanced or metastatic breast cancer (2L+)

Key Notes

NDA accepted August 2025. PDUFA June 5, 2026. First-in-class PROTAC (PROteolysis TArgeting Chimera) ER degrader — the first PROTAC to reach NDA filing stage. Phase 3 VERITAC-2 trial showed 43% reduction in risk of disease progression or death vs fulvestrant in ESR1-mutated patients (HR 0.57; p<0.001). Developed jointly with Pfizer (50/50 cost/profit share). Targets a crowded oral SERD space alongside Lilly's approved Inluriyo, but PROTAC mechanism may differentiate. Market-moving binary event.
⚠️ 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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