Core Viewpoint - ImmunityBio's stock has surged over 178% this year, with a pre-market increase of over 13% on Tuesday, currently trading at $6.31 per share [1] Group 1: Company Developments - ImmunityBio announced that the FDA is seeking additional information related to its supplemental biologics license application for Anktiva in combination with BCG for treating non-muscle invasive bladder cancer in patients with papillary tumors [1] - The FDA has requested certain additional information to support a potential resubmission of the application initially submitted last year for the papillary indication [1] - The company plans to submit the required information to the FDA within the next 30 days, and the additional information does not involve initiating or designing new clinical trials [1]

Core Viewpoint - ImmunityBio's stock has surged over 13% in pre-market trading and has increased by 178% year-to-date, currently priced at $6.31 [1] Group 1: FDA Interaction - The U.S. Food and Drug Administration (FDA) is seeking additional information related to ImmunityBio's supplemental biologics license application concerning Anktiva combined with Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer in patients with papillary tumors [1] - The FDA has suggested that the company provide certain additional information to support a potential resubmission of the application initially submitted last year for the papillary indication [1] - ImmunityBio plans to submit the required information to the FDA within the next 30 days, and the additional information does not involve initiating or designing new clinical trials [1]