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ImmunityBio Shows Strong Financial Growth

ImmunityBio, Inc. (NASDAQ: IBRX) has recently announced several significant updates, including the submission of a supplemental biologics license application (sBLA) for the use of Anktiva® plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. The company also submitted an expanded access protocol (EAP) for Anktiva for the treatment of lymphopenia.

In terms of financial performance, ImmunityBio reported impressive growth, with estimated net product revenue of approximately $16.5 million for the three-month period ended March 31, 2025. This represents a substantial 129% increase over the net product revenue of $7.2 million in the prior quarter. Notably, the company's Anktiva unit sales volume in Q1 2025 grew by 150% over the unit sales volume in Q4 2024.

Furthermore, the company's Anktiva sales momentum continued to trend upward in 2025, with sales volume in March representing a 69% increase month-over-month from February.

The submission of the sBLA for the papillary disease indication is particularly significant, as it expands the patient population benefiting from this therapy beyond the currently approved indication of bladder carcinoma in situ (CIS) with or without papillary disease. The data submitted to the FDA included efficacy results demonstrating durable complete remissions in patients with BCG-unresponsive NMIBC papillary disease. In a pivotal study, the combination immunotherapy of Anktiva plus BCG resulted in a disease-free survival (DFS) rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months in participants with papillary NMIBC.

Additionally, ImmunityBio's EAP submission for Anktiva in the treatment of lymphopenia is a significant development, especially considering the designation of regenerative medicine advanced therapy (RMAT) for this indication. Lymphopenia, the loss of natural killer cells and T cells, is induced by cancer itself and by standards of care including chemotherapy, radiation, steroids, and checkpoint inhibitors. The EAP, if authorized, would provide early access to patients and physicians desiring Anktiva in combination with standards of care.

The company's growth and developments indicate a promising trajectory, supported by its robust financial performance and advancements in therapeutic applications.

Today the company's shares have moved -4.2% to a price of $2.77. For more information, read the company's full 8-K submission here.

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