A High-Stakes Surge for ImmunityBio Shares

ImmunityBio US45256X1037

ImmunityBio's stock has embarked on a volatile and dramatic rally to begin the year, fueled by a potent mix of clinical progress, regulatory developments, and explosive revenue growth. However, this surge unfolds against a backdrop of persistent, deep financial losses, creating a narrative of high promise intertwined with significant risk.

The company's preliminary financial results for 2025 revealed staggering top-line expansion. Net product revenue reached $113 million, representing a 700% increase over the prior year. This surge is directly attributed to the growing commercial adoption of its therapy, ANKTIVA.

Despite this commercial momentum, profitability remains a distant prospect. For the full 2024 fiscal year, ImmunityBio reported a substantial net loss of $413.6 million. The current revenue growth, while impressive, is not yet sufficient to offset the company's high costs related to ongoing development and commercialization efforts.

Key Financial Metrics (Company Data):
* Preliminary 2025 Revenue: $113 Million
* Year-over-Year Revenue Growth: 700%
* 2024 Net Loss: $413.6 Million

Clinical and Regulatory Catalysts Drive Momentum

Two major announcements in January 2026 have been central to the renewed investor enthusiasm.

First, on January 20, the U.S. Food and Drug Administration (FDA) provided a pathway for resubmission of the supplemental Biologics License Application (sBLA) for ANKTIVA in BCG-unresponsive papillary bladder cancer. Critically for investors, the agency did not request new clinical trials. ImmunityBio intends to submit additional information within a 30-day window. This regulatory opening is supported by long-term data published in the Journal of Urology, indicating a 96% cancer-specific bladder survival rate and a bladder preservation rate exceeding 80% at three years for papillary disease patients treated with ANKTIVA combined with BCG.

Second, updated Phase 2 data from the QUILT-3.078 study in recurrent glioblastoma (GBM) were released on January 23, 2026. The trial is evaluating a chemotherapy-free combination of ANKTIVA and CAR-NK cells. Of 23 enrolled patients, 19 were still alive at the data cutoff, meaning the median overall survival had not yet been reached. Among 14 patients with evaluable data, the longest survival duration since relapse was 12 months and ongoing. The company noted a manageable safety profile across 219 administered doses.

A key finding from this study was evidence of "immune restoration." Patients began with significant lymphopenia, with a mean Absolute Lymphocyte Count (ALC) of 0.9 x 10³/µL. This measure showed a statistically significant improvement after just one treatment cycle and remained elevated for over 20 weeks—a factor investors watch closely, as a stabilized immune system is considered foundational for durable efficacy in immunotherapy.

International Expansion and Market Volatility

Adding to the positive narrative, the Saudi Food and Drug Authority granted accelerated approvals for ANKTIVA on January 14, 2026, for two indications:
* Non-muscle invasive bladder cancer with carcinoma in situ
* Metastatic non-small cell lung cancer in combination with checkpoint inhibitors

These approvals serve to expand the therapy's potential addressable market and demonstrate regulatory support outside the United States.

The confluence of these events triggered extreme trading activity. The stock's value increased more than threefold at points during January. Data cited by Motley Fool from Bloomberg indicated that short sellers faced mark-to-market losses of approximately $492 million by January 23, suggesting a substantial short squeeze amplified the upward move. Trading volume on January 23 reached 74.6 million shares, roughly 238% above the three-month average. After hitting an intraday high above $8, the stock closed at $6.45 on that date, down over 12% for the day. As of the latest data, shares trade at $6.15, down about 16% for the week but still showing a gain of over 200% in the prior 30-day period.

Upcoming Milestones

The near-term calendar holds specific events that could influence the stock's trajectory. ImmunityBio is scheduled to present its glioblastoma data at the "Stand Up to Cancer Glioblastoma Innovation Scientific Summit" in Pasadena on January 31, 2026. Furthermore, the company aims to complete enrollment for the BCG-naive NMIBC study QUILT-2.005 by the second quarter of 2026, with a planned Biologics License Application (BLA) submission before the end of that year.

The sustainability of ImmunityBio's share price advance will ultimately depend on its ability to convert clinical progress into additional regulatory approvals, maintain its sales growth, and meaningfully narrow its substantial losses.