Biotech Stock Market News: ImmunityBio Rallies on FDA Approval Path for ANKTIVA

In major stock market news today, ImmunityBio (NASDAQ: IBRX) surged to $6.48 on January 20, 2026, gaining 17.39% as investors reacted to breakthrough FDA developments. The biotech company’s share price jump reflects growing optimism around its lead immunotherapy candidate, ANKTIVA, which is advancing through regulatory discussions for expanded use in treating specific bladder cancer patients.

FDA End-of-Phase Meeting Sparks Investor Enthusiasm

The catalyst driving today’s stock market news is ImmunityBio’s FDA End-of-Phase meeting, where regulators outlined a clear resubmission pathway for ANKTIVA in BCG-unresponsive papillary bladder cancer treatment. This represents a significant milestone in the company’s regulatory strategy, signaling potential label expansion that could unlock new market opportunities for the therapy.

Trading activity reflected the significance of this announcement, with volume surging to 209.3 million shares—nearly 1,000% above the company’s typical three-month average of 19.1 million shares. This extraordinary volume demonstrates strong retail and institutional investor interest in the biotech company’s progress.

The enthusiasm builds on momentum from the previous week, when ImmunityBio’s stock had already doubled within five trading days, propelled by a series of positive developments. The current rally extends that run, underscoring sustained market confidence in the drug candidate’s trajectory.

Broader Market Moves: Mixed Signals Across Biotech

While ImmunityBio captured attention in the stock market news cycle, the broader indexes retreated. The S&P 500 declined 2.06% to close at 6,797, while the Nasdaq Composite fell 2.39% to 22,954, reflecting wider market headwinds.

Within the biotechnology sector, performance remained mixed and largely driven by stock-specific catalysts rather than sector-wide trends. Moderna finished at $43.00 (+4.56%), benefiting from its own momentum, while Novavax ended at $8.20 (+0.49%), suggesting divergent investor sentiment across biotech players. ImmunityBio’s outperformance highlights how clinical and regulatory progress can drive individual stock outperformance despite broader market weakness.

Investment Perspective: Runway and Risk

For investors watching this stock market news unfold, ImmunityBio presents a compelling but volatile story. The company has transformed dramatically—though it has fallen 81% since its 2015 IPO, the recent rally demonstrates how transformative regulatory news can reshape investment narratives in the biotech space.

ANKTIVA’s expanding indication list and geographic expansion plans suggest meaningful runway. The company has also reported triple-digit sales growth, albeit from a small revenue base. These elements position ImmunityBio for potential continued upside, though investors should expect elevated volatility as the company navigates regulatory processes and clinical development.

The stock’s trajectory serves as a reminder that biotech investing requires patience through regulatory cycles—but successful catalysts can deliver outsized returns when label expansions and approvals materialize.