Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
Reblozyl sBLA diterima; PDUFA ditetapkan 11 Maret 2027
FDA menerima supplemental Biologics License Application untuk Reblozyl plus terapi JAK inhibitor pada anemia terkait mielofibrosis. Badan tersebut menetapkan tanggal tindakan target PDUFA pada 11 Maret 2027, didukung oleh studi Fase 3 INDEPENDENCE.
Fakta utama
- Diajukan
- 30 Jul 2026, 11.05
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
BMYBristol-Myers Squibb- Aset
- luspatercept
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 11 Mar 2027
Kutipan sumber
EX-99.1 2 a2026q2ex991-filing.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED JULY 30, 2026 Document Exhibit 99.1 Bristol Myers Squibb Reports Second Quarter Financial Results for 2026 and Raises Full-Year Outlook Strong Performance Underscores Growth Portfolio Momentum and Pipeline Progress • Second quarter revenues increased 6% (+5% Ex-FX) to $13.0 billion ◦ Growth Portfolio revenues increased 15% (+14% Ex-FX) to $7.6 billion • GAAP EPS was $1.62 and non-GAAP EPS was $2.04 • Raising 2026 revenue guidance to a range of ~$49.0 billion to $50.0 billion; Increasing non-GAAP EPS range to $6.75 to $7.00 (PRINCETON, N.J., July 30, 2026) – Bristol Myers Squibb (NYSE: BMY) today reports results for the second quarter of 2026. “The Growth Portfolio continues to deliver, achieving 15% g