ImmunityBio Shares Hit 52-Week high After FDA Meeting on Anktiva

By Chris Wack

ImmunityBio shares were 36% higher, at $7.52, after the company said it recently held a Type B End-of-Phase meeting with the Food and Drug Administration regarding its supplemental Biologics License Application for Anktiva plus Bacillus Calmette-Guerin in non-muscle invasive bladder cancer with papillary tumors.

The stock hit its 52-week high of $7.98 earlier in the session, and is 163% higher in the past 12 months.

The clinical-stage immunotherapy company said the FDA recommended that the company provide additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication.

ImmunityBio said it has compiled the requested information and will submit it within the next 30 days. This additional information doesn't contemplate the initiation or design of a new clinical trial.

This submission follows a productive face-to-face meeting with senior FDA officials, the company said, during which the regulatory path forward for Anktiva in papillary NMIBC was collaboratively defined. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations and perspectives on the interpretation of the company's data.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 20, 2026 11:05 ET (16:05 GMT)