Giredestrant (+ everolimus)

Updated August 8, 2026·next FDA decision on the calendar

Giredestrant (+ everolimus) is a Roche/Genentech program in Adjuvant early breast cancer (ER+/HER2-). Its next catalyst is a PDUFA on Nov 30, 2026. Every date links its source.

RHHBY catalyst hub

Catalyst history

PDUFA · Nov 30, 2026RHHBY PDUFA · Dec 18, 2026RHHBY

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

About · Corrections · Methodology

Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.

Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.

© 2026 pdufa.bio. All rights reserved.