Jun. 24 at 1:59 PM
$CELC For Celcuity (NASDAQ: CELC), the July 17, 2026 PDUFA date is the FDA’s target deadline to decide whether to approve gedatolisib, the company’s lead breast cancer drug. The FDA granted the application Priority Review, which is reserved for drugs that may offer a significant improvement over existing treatments. 
What is Gedatolisib?
Gedatolisib is being reviewed for patients with:
• HR-positive (HR+)
• HER2-negative (HER2-)
• PIK3CA wild-type advanced breast cancer
These are patients whose cancer has progressed after prior treatment, including CDK4/6 inhibitors. 
Why are investors watching July 17 so closely?
This is a classic biotech “binary event”:
If approved:
• CELC could become a commercial-stage biotech.
• Gedatolisib would potentially be launched later in 2026.
• Revenue expectations could increase substantially. 
If rejected or delayed (CRL):
• The stock could fall sharply as investors reassess the timeline and approval odds.
