FDA Talks Set Path For Expanded Use For ImmunityBio's Anktiva In Bladder Cancer

Core Insights - ImmunityBio Inc. plans to submit additional information to the FDA regarding its supplemental biologics license application for Anktiva in treating papillary non-muscle invasive bladder cancer (NMIBC) within 30 days [1][2] - The stock has seen significant trading activity, with a session volume of 178.91 million compared to an average of 15.9 million [1] FDA Interaction - The FDA provided feedback during discussions on Anktiva in combination with Bacillus Calmette-Guérin for patients with BCG-unresponsive papillary NMIBC, which supports a potential resubmission of the sBLA filed initially in 2025 without requiring a new clinical trial [2] Clinical Results - Updated clinical results presented included over five years of follow-up data, showing disease-specific survival of approximately 96% at 36 months and cystectomy avoidance rates of 92% at one year and 82% at three years [3][4] - The safety profile of Anktiva is consistent with its currently approved indication in carcinoma in situ [4] Trial Data - The QUILT-3.032 Phase 2/3 trial, which enrolled 80 patients with high-grade, papillary-only BCG-unresponsive NMIBC, met its primary endpoint with a 12-month disease-free survival rate of 58.2% and progression-free survival rates of 94.9% at 12 months and 83.1% at 36 months [5] Market Performance - Anktiva is already approved in the U.S. and several international markets for BCG-unresponsive NMIBC with carcinoma in situ [6] - Preliminary net product revenue for Anktiva reached approximately $113 million for fiscal 2025, reflecting a 700% year-over-year increase [7] - For Q4 2025, revenue was about $38.3 million, marking a 20% quarter-over-quarter increase and a 431% year-over-year increase [7] Analyst Ratings - Piper Sandler maintains an Overweight rating for ImmunityBio and raises the price forecast from $5 to $7, while D. Boral Capital maintains a Buy rating with a price forecast of $24 [8] - ImmunityBio shares were up 20.44% at $6.64, reaching a new 52-week high [8]