Breyanzi: 재발/불응성 변연부 림프종에 대한 sBLA 수리, PDUFA 날짜는 2025년 12월 5일

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.

핵심 사실

제출: 2025년 10월 30일 AM 11:09
이벤트: 신청 접수
방향: 긍정적
기업: BMY브리스톨 마이어스 스퀴브
자산: lisocabtagene maraleucel
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2025년 12월 5일 · 결과 미기록

출처 발췌

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