Upcoming FDA decision · November 30, 2026
Giredestrant PDUFA date: FDA decision expected November 30, 2026
45 days to goRoche Holding AG (RHHBY) →
The FDA is expected to decide on Giredestrant from Roche Holding AG in Adjuvant ER-positive, HER2-negative stage I-III breast cancer by the PDUFA target action date of November 30, 2026. For Adjuvant ER-positive, HER2-negative stage I-III breast cancer. NDA, Priority Review. Verified against the company announcement on 2026-10-16.
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: roche.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 30
Target action date
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Questions about this FDA decision
- When is the PDUFA date for Giredestrant?
- The FDA's PDUFA target action date for Giredestrant is November 30, 2026. The FDA can act before that date, and the review can be extended.
- What is Giredestrant being reviewed for?
- The application under FDA review covers Adjuvant ER-positive, HER2-negative stage I-III breast cancer.
- Which company is developing Giredestrant?
- Roche Holding AG (RHHBY).
- 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).