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BMY PDUFA Date: iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-08-17 · Bristol-Myers Squibb Company · Relapsed/refractory multiple myeloma (RRMM)
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The story

iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone is under FDA review to treat Relapsed/refractory multiple myeloma (RRMM).
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

$62.37$54.46
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-08-17
Drug / candidateiberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone
IndicationRelapsed/refractory multiple myeloma (RRMM)
CompanyBristol-Myers Squibb Company
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04975997 · active

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FAQ

When is the BMY PDUFA date?
The FDA PDUFA target date for BMY (Bristol-Myers Squibb Company) is 2026-08-17 for iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BMY's drug iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone?
iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone is Bristol-Myers Squibb Company's candidate under FDA review for Relapsed/refractory multiple myeloma (RRMM).
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.