Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
IBRANCE (palbociclib) was approved by the FDA for HR+, HER2+ Metastatic Breast Cancer; the approval was announced on June 24, 2026.
Pfizer Inc., IBRANCE (palbociclib) · HR+, HER2+ Metastatic Breast Cancer.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (1/7/26) through T+5. Run-up high $28.55 on 4/6/26, low $24.72 on 6/23/26 (T-120 to T-1). FDA decision 6/24/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-06-24
OutcomeApproved
Drug / candidateIBRANCE (palbociclib) in combination with tr
CompanyPfizer Inc.
120-day run-up (T-120→T-1)-1.1%
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
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.