New York, January 20, 2026, 12:42 ET — Regular session
ImmunityBio, Inc. shares climbed roughly 24% to $6.82 by midday Tuesday after the company revealed the U.S. Food and Drug Administration provided guidance that could pave the way for a resubmission of its bladder cancer drug ANKTIVA. Earlier, the stock hit $7.97, fluctuating between $4.94 and $7.97 on about 159 million shares traded. (ImmunityBio)
Why it matters now: this update puts a regulatory timeline back on the radar for patients with BCG-unresponsive papillary non-muscle invasive bladder cancer, a group often steered toward radical cystectomy, meaning bladder removal. That’s a definitive outcome, and investors usually jump on any sign of a faster route to an alternative treatment. (RTTNews)
The company noted that the FDA requested more information to back a potential resubmission but did not require a new clinical trial. Piper Sandler analyst Edward Tenthoff bumped his price target from $5 to $7, keeping an Overweight rating, according to Investing.com. (Investing)
A supplemental biologics license application, or sBLA, seeks to expand the approved label of an existing biologic drug. NMIBC refers to early-stage bladder cancer that hasn’t spread into the muscle. BCG is a bacterial treatment administered straight into the bladder.
ImmunityBio highlighted long-term data from its QUILT-3.032 trial involving 80 patients, reporting about 96% bladder cancer-specific survival at three years, with over 80% retaining their bladders. CEO Richard Adcock said, “We appreciate the FDA’s collaboration and remain committed to delivering this therapy.” Founder Patrick Soon-Shiong noted that for patients with BCG-unresponsive papillary NMIBC, there are “no approved treatment options” other than the “life-altering” radical cystectomy. (Barchart)
ANKTIVA, administered alongside BCG, received FDA approval in April 2024 for adults with BCG-unresponsive NMIBC featuring carcinoma in situ, regardless of papillary tumor presence. (U.S. Food and Drug Administration)
Additional U.S.-approved treatments for BCG-unresponsive carcinoma in situ include Merck’s Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin. Both therapies are approved for CIS cases with or without papillary tumors. (U.S. Food and Drug Administration)
This name’s price action highlighted just how quickly it can react to regulatory news. Tuesday’s range was unusually wide, even for biotech.
That said, the FDA’s request doesn’t amount to approval. The agency could still push back, demanding additional data before it even considers a resubmission. Stretching out the process would increase the chances of delays and squeeze financing, despite ANKTIVA already being available for a more limited bladder cancer indication.
Investors await the company’s pledge to submit additional information “within the next 30 days,” as well as the FDA’s decision on whether it will accept the resubmission and establish a review timeline. (Businesswire)
