FDA Approves ImmunityBio's ANKTIVA for BCG-Unresponsive NMIBC, Expanding Label
IBRX has more than doubled off its 52-week low of $1.95.
Summary
The FDA approved Nogapendekin Alfa Inbakicept-Pmln (ANKTIVA) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) on October 14, 2026. The approval includes an expanded indication for high-grade papillary-only NMIBC, broadening the addressable patient population beyond the previously authorized CIS setting. The recommended dose is 400 mcg with BCG weekly for 6 weeks as induction therapy. This is the first US regulatory approval for the product; prior timeline items covered UAE marketing authorization and Q2 revenue, not US FDA action. The approval validates the company's lead asset in its largest market and should support revenue growth, though the company still faces a going concern warning and significant cash burn.
At the time of this announcement, IBRX was trading at $9.74 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $10.3B. The 52-week trading range was $1.95 to $12.43. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.