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RelevanteData PDUFA definida

Bristol Myers Squibb: Opdivo sBLA PDUFA definido para 8 de abril de 2026

A FDA concedeu revisão prioritária e atribuiu uma data-alvo PDUFA de 8 de abril de 2026 para a sBLA do Opdivo em combinação com doxorrubicina, vimblastina e dacarbazina em Linfoma de Hodgkin clássico em estágio III ou IV previamente não tratado. A EMA também validou o pedido de variação Tipo II correspondente, iniciando a revisão centralizada.

Fatos principais

Arquivado
5 de fev. de 2026, 12:07
Evento
Data PDUFA definida
Direção
Neutro
Empresa
BMYBristol-Myers Squibb
Ativo
nivolumab
Fonte
SEC 8-K
Confiança
Com fonte
Calendário
Decisão da FDA (PDUFA) · 8 de abr. de 2026 · Resultado não registrado

Trecho da fonte

EX-99.1 2 a2025q4ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED FEBRUARY 5, 2026 Document Exhibit 99.1 Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2025 Financial results reflect disciplined execution and focus on delivering long-term growth • Fourth quarter revenues increased 1% to $12.5 billion; Growth Portfolio revenues increased 16% to $7.4 billion ◦ GAAP EPS was $0.53 and non-GAAP EPS was $1.26; Both figures include net impact of $(0.60) due to the Acquired IPRD charges and licensing income • Full-year revenues were $48.2 billion; Growth Portfolio revenues increased 17% to $26.4 billion ◦ GAAP EPS was $3.46 and non-GAAP EPS was $6.15; Both figures include net impact of $(1.40) due to the Acquired IPRD charges and licensing income •

SEC 8-K

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