other material
confidence high
sentiment neutral
materiality 0.75
ImmunityBio provides N-803 BLA update with May 23 PDUFA, reports NSCLC OS data, and notes S1800D closure
ImmunityBio, Inc.
- BLA for N-803+BCG in BCG-unresponsive NMIBC with CIS; PDUFA date May 23, 2023; approval uncertain.
- QUILT 3.055 NSCLC pooled analysis (N=86) shows median OS 13.9 months vs historical 6-7.5 months.
- SWOG/NCI S1800D study (N-803+pembrolizumab) closed early for not meeting 60% disease control at 12 weeks.
- Company exploring partnering for N-803 intravesical commercialization and potential financing from Executive Chairman.
- Board appointed Cheryl L. Cohen as Lead Independent Director.