ImmunityBio Slapped With FDA Refusal To File Letter For Expanded Use Of Its Bladder Cancer Drug
1. IBRX received an FDA Refusal to File letter for sBLA of ANKTIVA. 2. Despite positive earlier feedback, FDA's RTF letter announced unexpected inconsistencies. 3. The RTF doesn’t affect previous ANKTIVA approval for another NMIBC indication. 4. Data presented showed impressive long-term survival rates in patients. 5. IBRX stock fell 16.50% in premarket trading following the news.