Registro de fonte primária
RelevanteData PDUFA definida
sBLA do Reblozyl aceito; PDUFA definido para 11 de março de 2027
A FDA aceitou o Supplemental Biologics License Application para Reblozyl em terapia combinada com inibidor de JAK na anemia associada à mielofibrose. A agência atribuiu a data-alvo de ação PDUFA para 11 de março de 2027, respaldada pelo estudo de Fase 3 INDEPENDENCE.
Fatos principais
- Arquivado
- 30 de jul. de 2026, 11:05
- Evento
- Data PDUFA definida
- Direção
- Neutro
- Empresa
BMYBristol-Myers Squibb- Ativo
- luspatercept
- Fonte
- SEC 8-K
- Confiança
- Com fonte
- Calendário
- Decisão da FDA (PDUFA) · 11 de mar. de 2027
Trecho da fonte
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