ImmunityBio announces FDA acceptance of sBLA for ANKTIVA plus BCG
The sBLA seeks to expand ANKTIVA's label to BCG-unresponsive NMIBC with papillary disease, with a PDUFA date of January 6, 2027.
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Biotechnology company developing immunotherapies for cancer and infectious diseases
immunitybio.comLast updated
In short: ImmunityBio reached record Q1 2026 revenue of $44.2 million and received FDA acceptance for a supplemental BLA to expand ANKTIVA's label.
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.
The agreement provides a second potential BCG source to address the U.S. shortage.
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