New York, January 21, 2026, 14:23 ET — Regular session
- ImmunityBio shares slipped roughly 2%, hitting $6.35 in afternoon trading.
- The company said the FDA requested more data that might back a resubmission aimed at broadening the Anktiva label for bladder cancer.
- Piper Sandler lifted its price target to $7 while maintaining an Overweight rating.
ImmunityBio shares dropped roughly 2% to $6.35 in Wednesday afternoon trading, as investors pared back after the biotech’s recent regulatory update. The stock swung between $5.74 and $6.64, with around 67 million shares changing hands.
The pullback is significant since the stock’s trajectory hinges on one key factor: how soon ImmunityBio can expand the U.S. label for Anktiva, its bladder-cancer immunotherapy on the market. A broader label would mean more patients gain access, especially in a treatment landscape that tightens quickly once standard options run out.
ImmunityBio announced Tuesday that the FDA requested additional data to support a resubmission of its supplemental biologics license application (sBLA) for Anktiva combined with Bacillus Calmette-Guérin (BCG) in treating BCG-unresponsive, non-muscle invasive bladder cancer with papillary tumors. The company plans to submit the information within 30 days. Importantly, the FDA did not require a new clinical trial, CEO Richard Adcock confirmed, saying the materials “will submit it within the next 30 days.” ImmunityBio highlighted long-term results from an 80-patient study, showing roughly 96% bladder cancer-specific survival at 36 months and over 80% bladder preservation at three years. Founder Dr. Patrick Soon‑Shiong claimed these survival rates are “higher than those reported” for other investigational treatments. Business Wire
The headline fueled momentum traders to stay active. Shares ended Tuesday 17.39% higher at $6.48, after spiking to $7.98. Trading volume surged to 209.3 million shares, per The Motley Fool.
Analyst notes gave ImmunityBio a boost. Piper Sandler bumped up its price target to $7 from $5, maintaining an Overweight rating. The firm forecasts roughly 700% growth in U.S. Anktiva net revenue, forecasting $113 million in 2025 and $180 million in 2026, according to a TheFly report cited by TipRanks.
Investors have shifted focus from headlines to the process itself: will the FDA deem any resubmission complete, and what review timeline follows? Companies turn to a supplemental BLA to broaden an approved biologic’s label.
The risk is clear. Regulators might demand additional analyses, call for yet another study, or turn down a resubmission for being incomplete—and that often spells trouble for fast-moving biotech trades.
The company’s FDA submission package is next on deck, along with any indication the agency might start its review. The upcoming earnings call is set for March 2, per Public.com’s calendar.
Related articles: NASDAQ:IBRX
