Gedatolisib PDUFA date: FDA decision expected June 25, 2027
The FDA is expected to decide on Gedatolisib from Celcuity Inc. (CELC) in PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer after endocrine therapy by the PDUFA target action date of June 25, 2027. For PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer after endocrine therapy. sNDA filing. AI-extracted from news: <![CDATA[FDA Accepts sNDA for Gedatolisib in PIK3CA-Mutant HR+/HER2– Breast Cancer]]>
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: cancernetwork.com · Data checked November 12, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Gedatolisib?
- The FDA's PDUFA target action date for Gedatolisib is June 25, 2027. The FDA can act before that date, and the review can be extended.
- What is Gedatolisib being reviewed for?
- The application under FDA review covers PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer after endocrine therapy.
- Which company is developing Gedatolisib?
- Celcuity Inc. (CELC) (CELC).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).