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MateryalNaitakda ang petsa ng PDUFA

Bristol Myers Squibb: Itinakda ng FDA ang petsa ng PDUFA para sa NDA ng iberdomide

Tinanggap ng FDA ang NDA para sa iberdomide kasama ang daratumumab/dexamethasone sa relapsed/refractory multiple myeloma. Itinalaga ang target na petsa ng aksyon ng PDUFA na Agosto 17, 2026, na nagmamarka ng unang potensyal na pag-apruba para sa isang ahente ng CELMoD.

Mahahalagang fact

Na-file
Abr 30, 2026, 11:01 AM
Kaganapan
Naitakda ang petsa ng PDUFA
Direksyon
Neutral
Kumpanya
BMYBristol-Myers Squibb
Asset
iberdomide
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · Ago 17, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 a2026q1ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED APRIL 30, 2026 Document Exhibit 99.1 Bristol Myers Squibb Reports First Quarter Financial Results for 2026 Financial Results Reflect Strong Execution and a Strengthened Foundation with Significant Pipeline Milestones Ahead • First quarter revenues increased 3% (+1% Ex-FX) to $11.5 billion ◦ Growth Portfolio revenues increased 12% (+9% Ex-FX) to $6.2 billion • GAAP EPS was $1.31 and non-GAAP EPS was $1.58; Both figures include net impact of $(0.03) due to the Acquired IPRD charges and licensing income • Reaffirms 2026 financial guidance with revenues of ~$46.0 billion to $47.5 billion; Non-GAAP EPS range of $6.05 to $6.35, with total revenues and non-GAAP EPS trending toward the upper end of the ranges (PRINCE

SEC 8-K

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