FDA authorizes ANKTIVA for lymphopenia in cancer patients

CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ: IBRX), a biotechnology firm valued at $2.35 billion, has received authorization from the U.S. Food and Drug Administration (FDA) for Expanded Access to ANKTIVA (nogapendekin alfa inbakicept-pmln), a treatment for lymphopenia in adults with refractory or relapsed solid tumors. According to InvestingPro data, analysts are optimistic about the company’s prospects, with two analysts recently revising their earnings estimates upward for the upcoming period. This condition, often a side effect of cancer therapies, leads to a critical depletion of immune cells and has been linked to poor prognosis and early mortality in cancer patients.

Lymphopenia, characterized by low Absolute Lymphocyte Counts (ALC

The FDA’s authorization extends to all patients with solid tumors who have not responded to first-line therapies such as chemotherapy, radiotherapy, or immunotherapy. This decision follows presentations at the ASCO Annual Meeting 2025, where ImmunityBio showcased that ANKTIVA, in combination with CAR-NK therapy, significantly extended overall survival in patients with 3rd to 6th line metastatic pancreatic cancer.

Dr. Patrick Soon-Shiong, Founder and Global Chief Scientific and Medical Officer of ImmunityBio, emphasized the survival benefit observed with ANKTIVA, suggesting it could alter the course of disease by restoring lymphocyte levels. While the company maintains a healthy liquidity position with a current ratio of 2.22, InvestingPro analysis indicates the company is rapidly consuming cash, with negative free cash flow of $376.91 million in the last twelve months. Subscribers to InvestingPro can access 8 additional key financial insights about ImmunityBio’s development pipeline and market position. The company’s Cancer BioShield platform, which includes ANKTIVA, aims to reverse the immune collapse that leads to disease progression and mortality.

In February 2025, ImmunityBio was granted a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for ANKTIVA and CAR-NK therapy for reversing lymphopenia in patients receiving standard cancer treatments.

The Cancer BioShield platform employs a multi-modal approach, including in-vivo stimulation and ex-vivo targeted cytotoxicity, to restore immune competence and offer long-term disease control. The platform’s effectiveness is measurable through blood count metrics: increases in ALC and reductions in the neutrophil-to-lymphocyte ratio (NLR) are indicative of its therapeutic impact.

The recent FDA authorization allows for expanded access to ANKTIVA for patients with solid tumors who have exhausted standard options, marking a potential shift in oncology focus from solely targeting tumors to also fortifying the immune system. With analysts forecasting 5.44% revenue growth and the stock showing low correlation to market movements (beta -0.1), investors seeking detailed analysis of ImmunityBio’s growth trajectory can find comprehensive financial metrics and expert insights on InvestingPro.

This article is based on a press release statement from ImmunityBio, Inc.

In other recent news, ImmunityBio, Inc. reported a significant 129% surge in first-quarter sales for 2025, with estimated net product revenue reaching approximately $16.5 million. This increase is attributed to a 150% growth in ANKTIVA unit sales volume over the previous quarter, following the award of a permanent J-code in January 2025. In regulatory developments, ImmunityBio submitted a supplemental Biologics License Application (sBLA) for ANKTIVA combined with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) focusing on papillary disease. Despite receiving a Refusal to File (RTF) letter from the FDA for this application, the company is seeking a meeting with the FDA to address inconsistencies and expedite the review process. Piper Sandler upgraded ImmunityBio’s stock rating from Neutral to Overweight, raising the price target to $5, citing positive prospects for ANKTIVA and other therapies. Meanwhile, BTIG maintained a Buy rating with a $6 target, expressing optimism about ANKTIVA’s sales momentum. H.C. Wainwright also reaffirmed a Buy rating with an $8 target, noting ANKTIVA’s established position in the NMIBC market. ImmunityBio’s continued efforts in advancing its product pipeline and addressing regulatory challenges remain focal points for investors.

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