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AZN PDUFA Date: Camizestrant

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on September 4, 2026. Decision page with the source and measured reaction.
FDA decision Approved September 4, 2026 · AstraZeneca PLC · Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer (mBC)
More Cancer & Oncology FDA decisions →All December 2026 PDUFA dates →

The story

Camizestrant was approved by the FDA on September 4, 2026 to treat advanced ER-positive/HER2-negative breast cancer (the oral SERD camizestrant).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)CELC . 2026-07-17Same area: Oncology . Gedatolisib with FulvestrantEXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

AZN run-up into the PDUFA (last ~120 days)

$208.67$176.28
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved September 4, 2026
Drug / candidateCamizestrant
IndicationHormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer (mBC)
CompanyAstraZeneca PLC
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04964934 · Breakthrough Therapy Designation (BTD)

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See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on AZN's Camizestrant?
The FDA decided AZN's (AstraZeneca PLC) application for Camizestrant on September 4, 2026: Approved. pdufa.bio does not hold a sponsor-disclosed goal date for this application. Verify against the linked primary source.
What is AZN's drug Camizestrant?
Camizestrant is AstraZeneca PLC's drug, approved by the FDA on September 4, 2026 for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer (mBC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.