ImmunityBio’s ANKTIVA Shows 69.7% Response Rate but FDA Warning Triggers 21% Plunge
ImmunityBio’s ANKTIVA plus BCG achieved a 69.7% response rate and 22.1-month duration versus 53.4% and 9.7 months for nadofaragene, with 68% fewer adverse events than TAR-200. Shares plunged 21% after the FDA issued a warning letter over misleading Anktiva claims, sparking a $2 billion loss and securities class action lawsuit.
1. ANKTIVA Combination Outperforms Rivals
ImmunityBio’s ANKTIVA in combination with BCG achieved a 69.7% complete response rate and a median response duration of 22.1 months in BCG-unresponsive bladder cancer patients, outperforming nadofaragene firadenovec’s 53.4% rate and 9.7-month duration and showing a 68% reduction in treatment-related adverse events versus TAR-200.
2. Patent Protection Extended Through 2035
The company secured five U.S. patents for ANKTIVA in bladder cancer, extending exclusivity through 2035 and strengthening its commercial franchise amid growing sales momentum.
3. FDA Warning Letter Spurs Lawsuit and Share Plunge
The FDA issued a warning letter citing misleading efficacy claims by the company’s executive chairman, triggering a 21% share decline and a $2 billion market value loss, while investors launched a securities class action lawsuit covering the January-March 2026 trading period.