一次情報の記録
重要PDUFA 日設定
Bristol Myers Squibb: Opdivo sBLA PDUFAを2026年4月8日に設定
FDAは優先審査を承認し、未治療のStage IIIまたはIVの古典的ホジキンリンパ腫に対するdoxorubicin、vinblastine、dacarbazineとのOpdivo併用療法のsBLAについて、PDUFA目標日を2026年4月8日に設定した。EMAも対応するType II変異申請を検証し、中央審査を開始した。
主要事実
出典の抜粋
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 •