ImmunityBio Gets FDA Authorization for Expanded Access to Recombinant BCG for Bladder Cancer Treatment

MT Newswires Live

2025/02/19

ImmunityBio (IBRX) said Wednesday it has received the US Food and Drug Administration's authorization for an expanded access program to provide recombinant Bacillus Calmette-Guerin, addressing the nationwide shortage of TICE BCG for bladder cancer treatment.

The alternative BCG, developed by the Serum Institute of India, has performed well in European trials for non-muscle invasive bladder cancer, exhibiting strong immunogenicity and enhanced safety over previous strains.

ImmunityBio said that rBCG supplies are now available, with shipments starting immediately through an FDA Expanded Access Program.

Shares of ImmunityBio were up more than 8% in recent Wednesday trading.

Price: 3.62, Change: +0.27, Percent Change: +8.06

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