ImmunityBio Inc. (IBRX) shares climbed during Tuesday's premarket trading as the biotechnology company advanced its regulatory efforts on multiple fronts, with particularly encouraging news from Saudi Arabia.
The catalyst? Productive discussions with the Saudi Food and Drug Authority regarding ImmunityBio's recombinant BCG (rBCG) treatment. In those talks, the Saudi FDA actively encouraged the company to submit a regulatory package for its rBCG product to improve access in Saudi Arabia, which is grappling with the global BCG shortage affecting bladder cancer treatment.
ImmunityBio plans to submit the regulatory package in the coming weeks, a move that could significantly impact bladder cancer treatment availability throughout the region. Given the worldwide shortage of traditional BCG, the timing couldn't be better.
Expanding Anktiva's Reach
Meanwhile, ImmunityBio is also working to expand its flagship product Anktiva (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors for various tumor types. The scientific case for this expansion draws strength from data coming out of the QUILT-3.055 Phase 2b basket trial, which enrolled 147 patients across multiple tumor types.
The results from the non-small cell lung cancer cohort (86 patients) look particularly interesting. Adding Anktiva to the same checkpoint inhibitor on which patients had already progressed showed a median overall survival of 14.1 months, with 12-month and 18-month survival rates hitting 57% and 34%, respectively. That's meaningful data for patients who've run out of other options.
In January, the company announced plans to submit additional information to the U.S. Food and Drug Administration within 30 days following a Type B end-of-phase meeting related to its supplemental biologics license application for Anktiva in papillary non-muscle invasive bladder cancer.
Revenue Surge Validates Commercial Progress
ImmunityBio recently announced that preliminary net product revenue for Anktiva reached approximately $113 million for fiscal 2025. That represents a remarkable 700% increase year-over-year, suggesting the commercial launch is gaining serious traction.
Technical Picture
From a technical perspective, the stock is trading 5.47% above its 20-day simple moving average and 12.3% above its 100-day simple moving average, indicating solid short-term momentum. Shares have climbed 77.46% over the past 12 months and are currently positioned closer to their 52-week highs than lows.
The Relative Strength Index sits at 50, indicating a neutral position, while the MACD is above its signal line, suggesting bullish momentum. The combination points to mixed momentum with potential for continued upward movement.
- Key Resistance: $8.00
- Key Support: $5.50
Earnings on the Horizon
ImmunityBio is scheduled to report earnings on March 2, 2026. Analysts are expecting a loss of 9 cents per share on revenue of $37.51 million, which would represent a significant jump from the $7.55 million in the year-ago period.
Analyst Consensus: The stock carries a Buy rating with an average price target of $11.80. Recent analyst actions include:
- HC Wainwright & Co.: Buy (Raises Target to $10)
- D. Boral Capital: Buy (Maintains Target at $24)
- BTIG: Buy (Raises Target to $9)
Momentum Rankings
ImmunityBio scores exceptionally well on momentum metrics, with a bullish score of 95.69, indicating the stock is outperforming the broader market.
ETF Exposure
For investors interested in ETF exposure, the Virtus LifeSci Biotech Products ETF (BBP) holds ImmunityBio as 4.03% of its portfolio weight.
Price Action: ImmunityBio shares were up 1.51% at $6.040 at the time of publication on Tuesday.