pdufa.bio
HomeDecisions › CELC 2026-07-14

CELC FDA decision — Jul 14, 2026

✓ APPROVED

REVTORPYK (gedatolisib) plus fulvestrant approved for HR+/HER2−, PIK3CA wild-type advanced breast cancer (Jul 14 2026).

Run-up into the decision (T-120 → T+5)

PDUFA 7/14/26$144.98$87.321/20/26
Daily close, T-120 (1/20/26) through T+1. Run-up high $144.98 on 5/4/26, low $87.32 on 6/16/26 (T-120 to T-1). FDA decision 7/14/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-07-14
OutcomeApproved
Drug / candidateGedatolisib with Fulvestrant - (VIKTORIA-1)
IndicationHR+/HER2− advanced breast cancer (PIK3CA wild-type)
CompanyCelcuity Inc.
Market-cap tierMid
120-day run-up (T-120→T-1)-1.5%
Cohort decision-day move (history)±2% median

The PDUFA goal date was July 17, 2026; the FDA approved on July 14, 2026, three days early. This page previously carried another company's chart, indication and dates through a template-copy bug; it was rebuilt from Celcuity's own price history on July 15, 2026. See /corrections.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.

Primary source: Celcuity investor releases