1차 출처 기록
중대PDUFA 날짜 확정
브리스톨마이어스스큅: FDA, iberdomide NDA에 대한 PDUFA 날짜 지정
FDA accepted the NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma. A PDUFA target action date of August 17, 2026 was assigned, marking the first potential approval for a CELMoD agent.
핵심 사실
- 제출
- 2026년 4월 30일 AM 11:01
- 이벤트
- PDUFA 날짜 확정
- 방향
- 중립
- 출처
- SEC 8-K
- 신뢰도
- 출처 확인
- 캘린더
- FDA 심사 결정 (PDUFA) · 2026년 8월 17일 · 승인
출처 발췌
EX-99.1 2 a2026q1ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED APRIL 30, 2026 Document Exhibit 99.1 Bristol Myers Squibb Reports First Quarter Financial Results for 2026 Financial Results Reflect Strong Execution and a Strengthened Foundation with Significant Pipeline Milestones Ahead • First quarter revenues increased 3% (+1% Ex-FX) to $11.5 billion ◦ Growth Portfolio revenues increased 12% (+9% Ex-FX) to $6.2 billion • GAAP EPS was $1.31 and non-GAAP EPS was $1.58; Both figures include net impact of $(0.03) due to the Acquired IPRD charges and licensing income • Reaffirms 2026 financial guidance with revenues of ~$46.0 billion to $47.5 billion; Non-GAAP EPS range of $6.05 to $6.35, with total revenues and non-GAAP EPS trending toward the upper end of the ranges (PRINCE