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Live Company Data
NCM
Updated
just now
· Data: FMP
Current Price
$122.46
+1095.90%
+$112.22 today
Day: $121.46 – $125.66
Market Cap
N/A
Shares out: 48.34M
Float: 29.66M
52-Week Range
Current price is at 96% of 52-week range
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Indication
HR+/HER2-/PIK3CA wild-type advanced breast cancer (2nd-line post CDK4/6i)
Key Notes
NDA accepted under FDA Real-Time Oncology Review (RTOR) program — PDUFA July 17, 2026. Phase 3 VIKTORIA-1 PIK3CA WT cohort: gedatolisib triplet (+ palbociclib + fulvestrant) showed median PFS 9.3 vs 2.0 months (HR=0.24; p<0.0001), ORR 31.5%; doublet showed PFS 7.4 vs 2.0 months (HR=0.33). Results published in JCO March 9, 2026. PIK3CA mutant cohort data expected Q2 2026 (potential ASCO presentation). Celcuity hiring sales force Q2 2026 for pre-launch. If approved, first treatment specifically indicated for PIK3CA WT patients (~60% of 2L HR+ breast cancer, ~37,000 patients/year in US). Market cap ~$1.7B (sub-$7B). Pan-PI3K/mTOR inhibitor licensed from Pfizer.
⚠️ 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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