The biotech sector is witnessing a remarkable event as ImmunityBio experiences a parabolic rally to begin the year. This surge has caught bearish investors off guard, propelling the stock to unprecedented levels. While speculative forces are at play, the movement is also underpinned by concrete regulatory developments and clinical data. The critical question for the market is determining what portion of this ascent is driven by fundamental progress versus a classic short squeeze.
Operational Milestones Provide Fundamental Support
Beyond the dramatic price action, ImmunityBio has reported several key operational advancements that contribute to the bullish sentiment:
- International Regulatory Success: The Saudi Food and Drug Authority (SFDA) has granted approval for ANKTIVA in the treatment of non-muscle invasive bladder cancer (NMIBC). More significantly, the SFDA also approved the therapy for metastatic non-small cell lung cancer (NSCLC)—marking the world’s first regulatory authorization for ANKTIVA in this indication, which potentially opens access to a substantially larger market.
- Promising Early Clinical Data: The company announced positive preliminary results from a Phase 1 study of its CAR-NK cell therapy for blood cancers. Complete remissions were observed, with responses in some patients lasting up to 15 months. For an early-stage program, this serves as an important proof of concept.
- Insider Transaction Under Pre-Arranged Plan: A filing with the U.S. Securities and Exchange Commission (SEC) revealed that Director Simon Barry J. sold 151,967 shares on January 20, 2026, a transaction valued at over $1 million. Crucially, this sale was executed under a Rule 10b5-1 trading plan established in September 2024. Such plans pre-schedule transactions to standardize insider trading activity.
These developments provide a substantive foundation for investor interest that extends beyond mere technical market mechanics.
Clarified FDA Pathway Ignites Investor Confidence
The immediate catalyst for the recent volatility was a pivotal meeting with the U.S. Food and Drug Administration (FDA). Discussions centered on a potential resubmission pathway for the supplemental Biologics License Application (sBLA) for ANKTIVA, ImmunityBio’s lead product candidate, targeting BCG-unresponsive NMIBC with papillary tumors.
A key takeaway for investors is the company’s expectation that it can supply the FDA with the requested additional information within the next 30 days, without needing to initiate a new clinical trial program. This clarification of the regulatory timeline has markedly improved market sentiment, lifting the equity to a new 52-week high.
Should investors sell immediately? Or is it worth buying ImmunityBio?
The stock closed at $7.34 in the latest session, representing a staggering year-to-date gain of approximately 263%. This price level sits far above its key moving averages, illustrated by a distance of over 200% from its 200-day line.
A Crowded Trade Amplifies Volatility
The explosive rally has precipitated a severe short squeeze. During the first twelve trading days of 2026, ImmunityBio shares skyrocketed by 227%. This has resulted in an estimated $492 million in mark-to-market losses for investors who had bet on the stock’s decline.
The situation is exacerbated by an exceptionally high level of short interest. Roughly 35% of the company’s freely tradable shares have been sold short. This “crowded” bearish trade leaves the stock highly susceptible to further squeeze-driven volatility, as short sellers may be forced to cover their positions by buying back shares.
The result is a trading environment defined by extreme price swings, where fundamental news and technical factors are tightly intertwined.
Outlook: Elevated Volatility Likely to Persist
The current setup remains explosive, combining a clarified U.S. regulatory path for ANKTIVA, initial international approvals, encouraging early oncology data, and extreme short interest. With approximately one-third of the free float sold short and key regulatory milestones approaching, the stock is prone to abrupt moves in either direction. The coming weeks, as ImmunityBio works to submit its supplemental FDA materials, will be critical in determining whether fundamental momentum can ultimately prevail over the highly speculative volatility.
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