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MaterialTanggal PDUFA ditetapkan

Bristol Myers Squibb: FDA tetapkan tanggal PDUFA untuk NDA iberdomide

FDA menerima NDA untuk iberdomide plus daratumumab/dexamethasone pada multiple myeloma yang kambuh/refrakter. Tanggal aksi target PDUFA 17 Agustus 2026 ditetapkan, menandai persetujuan potensial pertama untuk agen CELMoD.

Fakta utama

Diajukan
30 Apr 2026, 11.01
Peristiwa
Tanggal PDUFA ditetapkan
Arah
Netral
Perusahaan
BMYBristol-Myers Squibb
Aset
iberdomide
Sumber
SEC 8-K
Keyakinan
Bersumber
Kalender
Keputusan FDA (PDUFA) · 17 Agu 2026 · Disetujui

Kutipan sumber

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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