CRL adds to ImmunityBio uncertainty
ImmunityBio (Nasdaq: IBRX) lost 54% of its market value on Thursday.
The Californian company announced in a filing with the US Securities and Exchange Commission that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for its product candidate, Anktiva (N-803).
Filed in May last year, the submission requested FDA approval for Anktiva in combination with Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without Ta/T1 papillary disease.
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