Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
Tinanggap ang Reblozyl sBLA; Itinakda ang PDUFA sa Marso 11, 2027
Tinanggap ng FDA ang supplemental Biologics License Application para sa Reblozyl kasama ang JAK inhibitor therapy sa myelofibrosis-associated anemia. Nagtalaga ang ahensya ng PDUFA target action date na Marso 11, 2027, na suportado ng Phase 3 INDEPENDENCE study.
Mahahalagang fact
- Na-file
- Hul 30, 2026, 11:05 AM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
BMYBristol-Myers Squibb- Asset
- luspatercept
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Mar 11, 2027
Sipi mula sa source
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