Investing.com -- ImmunityBio, an immunotherapy company, saw its shares surge by up to 20%, marking the most significant intraday rise since October 28.
The spike in share price followed the company's announcement of its substantial progress in ongoing talks with the FDA. These discussions revolve around three areas of ImmunityBio's clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC).
The company is preparing to submit a supplemental Biologics License Application (sBLA) in 2025. This application pertains to its innovative treatment targeting Bacillus Calmette-Guérin (BCG) unresponsive NMIBC in the papillary indication.
The inclusion of the papillary indication could potentially increase the number of patients benefiting from this therapy. It may also enable patients to avoid the high morbidity and mortality linked with radical total cystectomy.
Furthermore, ImmunityBio is planning a regulatory submission for an alternative source of BCG in the first quarter of 2025. This submission is being prepared in collaboration with the Serum Institute of India.
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