← Back to Calendar

vepdegestrant (ARV-471)

Arvinas / Pfizer · $ARVN
Standard Review Fast Track NDA
PDUFA Date
June 5, 2026
Time Remaining
46 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 4m ago · Data: FMP
Current Price
$11.00 +27.91%
+$2.40 today
Day: $10.97 – $11.34
Market Cap
N/A
Shares out: 63.96M
Float: 55.35M
52-Week Range
$5.90
$14.51
Current price is at 59% of 52-week range
Avg Volume
863K
Beta
1.98
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Track $ARVN catalysts → get weekly FDA alerts Subscribe Free on Substack →

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.

Discussion

Share your analysis, research, or questions about this catalyst. No account required.

Rate limit: 5/hr per email
Loading comments...
← Back to Full Calendar