一次情報の記録
重要PDUFA 日設定
ImmunityBio: FDA、乳頭状NMIBC向けANKTIVA sBLAのPDUFAを2027年1月6日に設定
FDAはCISを伴わないBCG未応答NMIBC乳頭状疾患に対するANKTIVAとBCGの併用療法のsBLAを受理した。PDUFA目標アクション日として2027年1月6日が設定され、この新適応症に対する正式な規制審査タイムラインが確立された。
主要事実
出典の抜粋
EX-99.1 2 ibrx-202684x8kexhibit991.htm EX-99.1 Document EXHIBIT 99.1 ImmunityBio Reports Record Q2 2026 Net Product Revenue of $50.7 Million, Up 92% Year-Over-Year; First-Half Revenue Up 121% to $94.8 Million • Q2 2026 net product revenue of $50.7 million, up 92% year-over-year and 15% sequentially from Q1 2026, marking the eighth consecutive quarter of sequential revenue growth since the commercial launch of ANKTIVA ® , driven by continued adoption among U.S. urologists and strong market access • First-half 2026 net product revenue of $94.8 million, up 121% compared with the first-half of 2025 • In July 2026, we announced the Emirates Drug Establishment of the United Arab Emirates granted the broadest marketing authorization for ANKTIVA across BCG-unresponsive NMIBC for CIS and papillar