一次情報の記録
重要PDUFA 日設定
ブリストル・マイヤーズ スクイブ:FDAがイベルドミドNDAのPDUFA日を設定
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.
主要事実
- 提出
- 2026年4月30日 11:01
- イベント
- PDUFA 日設定
- 方向
- 中立
- アセット
- iberdomide
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- カレンダー
- FDA 審査決定 (PDUFA) · 2026年8月17日 · 承認
出典の抜粋
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