Catatan sumber primer
MaterialPermohonan diterima
Breyanzi sBLA diterima dengan PDUFA 5 Des 2025 untuk limfoma zona marginal r/r
FDA menerima supplemental BLA untuk Breyanzi pada limfoma zona marginal yang kambuh/refrakter (≥2 lini terapi sebelumnya) dan memberikan Priority Review. Badan tersebut menetapkan tanggal target PDUFA pada 5 Desember 2025, yang menjadi titik keputusan regulasi jangka pendek untuk indikasi baru ini.
Fakta utama
- Diajukan
- 30 Okt 2025, 11.09
- Peristiwa
- Permohonan diterima
- Arah
- Positif
- Perusahaan
BMYBristol-Myers Squibb- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 5 Des 2025 · Hasil belum tercatat
Kutipan sumber
EX-99.1 2 a2025q3ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED OCTOBER 30, 2025 Document Exhibit 99.1 Bristol Myers Squibb Reports Third Quarter Financial Results for 2025 Performance Marked by Continued Growth Portfolio Momentum, Pipeline Advancements and Strategic Business Development • Third quarter revenues increased 3% (+2% Ex-FX) to $12.2 billion ◦ Growth Portfolio revenues increased 18% (+17% Ex-FX) to $6.9 billion • GAAP EPS was $1.08 and non-GAAP EPS was $1.63; Both figures include net impact of $(0.20) due to the Acquired IPRD charges and licensing income • Raising 2025 revenue guidance to a range of ~$47.5 billion to $48.0 billion; Updating non-GAAP EPS range to $6.40 to $6.60, inclusive of an $(0.80) per share net impact from Acquired IPRD charges and licensi