Giredestrant (+ everolimus) is a Roche Holding AG program in Adjuvant early breast cancer (ER+/HER2-). Its PDUFA date is Nov 30, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indications under review: Adjuvant early breast cancer (ER+/HER2-); ER+/HER2-, ESR1-mutated metastatic breast cancer. Sponsor: Roche Holding AG (RHHBY). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 2 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Giredestrant (+ everolimus)'s next FDA decision or readout?
Giredestrant (+ everolimus)'s PDUFA date is Nov 30, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Giredestrant (+ everolimus)'s most recent FDA decision?
No FDA decision for Giredestrant (+ everolimus) is in our archive yet.
What is Giredestrant (+ everolimus) used for?
In our records Giredestrant (+ everolimus) is under review or in development for Adjuvant early breast cancer (ER+/HER2-); ER+/HER2-, ESR1-mutated metastatic breast cancer.
Who makes Giredestrant (+ everolimus)?
Roche Holding AG (RHHBY).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
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