Breyanzi:再発・難治性辺縁帯リンパ腫のsBLAが受理、PDUFA日は2025年12月5日

FDA accepted the supplemental BLA for Breyanzi in relapsed/refractory marginal zone lymphoma (≥2 prior lines) and granted Priority Review. The agency set a PDUFA goal date of December 5, 2025, establishing a near-term regulatory decision point for this new indication.

主要事実

提出: 2025年10月30日 11:09
イベント: 申請受理
方向: ポジティブ
企業: BMYブリストル・マイヤーズスクイブ
アセット: lisocabtagene maraleucel
出典: SEC 8-K
信頼度: 出典あり
カレンダー: FDA 審査決定 (PDUFA) · 2025年12月5日 · 結果未記録

出典の抜粋

EX-99.1 2 a2025q3ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED OCTOBER 30, 2025 Document Exhibit 99.1 Bristol Myers Squibb Reports Third Quarter Financial Results for 2025 Performance Marked by Continued Growth Portfolio Momentum, Pipeline Advancements and Strategic Business Development • Third quarter revenues increased 3% (+2% Ex-FX) to $12.2 billion ◦ Growth Portfolio revenues increased 18% (+17% Ex-FX) to $6.9 billion • GAAP EPS was $1.08 and non-GAAP EPS was $1.63; Both figures include net impact of $(0.20) due to the Acquired IPRD charges and licensing income • Raising 2025 revenue guidance to a range of ~$47.5 billion to $48.0 billion; Updating non-GAAP EPS range to $6.40 to $6.60, inclusive of an $(0.80) per share net impact from Acquired IPRD charges and licensi

SEC 8-K