Core Insights - ImmunityBio's Anktiva received FDA approval in April 2024 for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) [1][8] - The approval is based on significant safety and efficacy results from a late-stage study involving 77 NMIBC CIS patients [8] - Anktiva's unique mechanism of action activates natural killer (NK) and killer T cells, providing a robust immune response against BCG-resistant tumor cells [9] Company Performance - Year to date, ImmunityBio's shares have increased by 44.8%, significantly outperforming the industry, which saw a decline of 4.1% [2] - Following the announcement of insurance coverage for Anktiva, the company's shares gained 16.7% in the past week, enhancing patient access to the drug [16] Clinical Study Results - The study reported a complete response rate of 62%, with the duration of complete response (DOR) exceeding 47 months as of November 2023 [17] - Patients in the study were treated for up to 37 months, with ongoing monitoring for up to five years [3] Product Administration and Supply - Anktiva can be administered by urologists in their offices without special handling, increasing accessibility for patients [18] - ImmunityBio has enough drug substance to produce 170,000 doses of Anktiva, ensuring preparedness for anticipated demand [19] Future Prospects - Initial sales figures for Anktiva combined with BCG are expected to be reported in the second-quarter earnings release in July or August [7] - The company is evaluating Anktiva for other cancer indications and HIV in separate clinical studies [11]
ImmunityBio (IBRX) Gains 17% in the Past Week: Here's Why