ImmunityBio (IBRX) said Tuesday it completed submissions to the US Food and Drug Administration, including the supplemental biologics license application for ANKTIVA plus Bacillus Calmette-Guerin to treat BCG-unresponsive non-muscle invasive bladder cancer in papillary disease.
The company also submitted an expanded access protocol to the FDA to make ANKTIVA available for the treatment of lymphopenia, according to a statement.
ImmunityBio also reported preliminary net product revenue of about $16.5 million for Q1, up from $7.2 million in Q4.
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