
Shares of drug developer ImmunityBio IBRX.O fall 4.35% to $5.28 premarket
Co says it is preparing to resubmit its application seeking U.S. approval for use of bladder cancer drug Anktiva in a broader group of patients, following new guidance from U.S. FDA
Co says FDA asked for more information but no new trials; plans resubmission within 30 days
Long-term data showed nearly all patients on Anktiva along with BCG survived ≥3 years and over 80% kept their bladder, avoiding surgery - IBRX
BCG is a decades-old bladder-cancer treatment made from a weakened bacterium that helps the immune system attack cancer cells
Co's Anktiva is already cleared in U.S., UK, Saudi Arabia and conditionally in EU for related uses - IBRX
As of last close, stock down ~23% over the past year