Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
ImmunityBio: FDA nagtakda ng Enero 6 2027 PDUFA para sa ANKTIVA sBLA sa papillary NMIBC
Tinanggap ng FDA ang sBLA para sa ANKTIVA kasama ang BCG sa BCG-unresponsive NMIBC papillary disease na walang CIS. Itinalaga ang PDUFA target action date na Enero 6, 2027, na nagtatatag ng pormal na regulatory review timeline para sa bagong indikasyon na ito.
Mahahalagang fact
- Na-file
- Ago 4, 2026, 11:36 AM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Positibo
- Kumpanya
IBRXImmunityBio- Asset
- ANKTIVA
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Ene 6, 2027
Sipi mula sa source
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