10:10 AM EST, 02/19/2025 (MT Newswires) -- 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 ( IBRX ) said that rBCG supplies are now available, with shipments starting immediately through an FDA Expanded Access Program.

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

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