UAE Approves ANKTIVA for Bladder and Lung Cancer, First Broad NMIBC Label
IBRX has more than doubled off its 52-week low of $1.95.
Summary
ImmunityBio secured UAE marketing authorization for ANKTIVA in two indications: BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and metastatic non-small cell lung cancer (NSCLC). The NMIBC approval is the first globally to cover the full disease spectrum, including papillary-only tumors without CIS, addressing a significant unmet need. The NSCLC indication targets checkpoint-refractory patients, a population with limited options. This is the fifth regulatory jurisdiction, expanding ANKTIVA's reach to 34 countries. The news follows strong Q1 revenue growth and a recent BCG supply agreement, reinforcing commercial momentum. With a market cap around $7.2B, this regulatory win could open new revenue streams and strengthen the global commercial case.
Updates
· Benzinga — The UAE approval includes a 71% complete response rate in CIS patients and 58.2% disease-free survival at 12 months in papillary-only patients. Shares rose 5.5%.
At the time of this announcement, IBRX was trading at $6.86 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $7.2B. 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 8 out of 10. Source: BusinessWire.