ImmunityBio presents new data across lung and bladder cancers
The data includes Phase 3 trial results in advanced NSCLC and a comparative analysis in BCG-unresponsive NMIBC.
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Biotechnology company developing immunotherapies for cancer and infectious diseases
immunitybio.comLast updated
In short: ImmunityBio achieved record revenues and secured FDA acceptance for an ANKTIVA label expansion while resolving advertising compliance issues.
The data includes Phase 3 trial results in advanced NSCLC and a comparative analysis in BCG-unresponsive NMIBC.
The sBLA seeks to expand ANKTIVA's label to BCG-unresponsive NMIBC with papillary disease, with a PDUFA date of January 6, 2027.
The data show higher complete response rates and longer duration compared to nadofaragene and TAR-200, with fewer adverse events.
The five patents cover methods, compositions, and kits for treating non-muscle invasive bladder cancer, reinforcing the company's commercial position.
ImmunityBio CEO fights back against FDA advertising allegations, while insiders prepare stock sales. Despite warning signals, the stock records a 375 percent annual gain.
ImmunityBio has resubmitted an sBLA for the combination following an FDA request for updated efficacy data.
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