ImmunityBio, Inc.: FDA expands ANKTIVA indication

What happened On Oct 14, 2026, ImmunityBio, Inc. announced that the U.S. Food and Drug Administration expanded the approved indication for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only tumors. The company furnished the full text of its press release as Exhibit 99.1 to the Form 8-K.

Key details

• Announcement date: Oct 14, 2026.
• Product: ANKTIVA (nogapendekin alfa inbakicept-pmln) administered in combination with BCG.
• New indication language in the filing: "BCG-unresponsive NMIBC with papillary-only tumors."
• Press release furnished as Exhibit 99.1 to the Form 8-K.

Why it may matter Item 7.01 (Regulation FD Disclosure) was reported; this item covers public disclosure of material information. Item 9.01 notes the exhibit filing of the press release. This filing does not show why the company acted.