UAE Grants Broadest-Ever Bladder Cancer Approval to ImmunityBio's ANKTIVA
IBRX has more than doubled off its 52-week low of $1.95.
Summary
The UAE has authorized ANKTIVA for the full spectrum of BCG-unresponsive NMIBC, including both CIS and papillary disease—the broadest label globally. This follows yesterday's initial approval announcement and adds key clinical context: a 71% complete response rate in CIS patients and 58.2% disease-free survival at 12 months in papillary-only patients. The approval also covers metastatic NSCLC, expanding the drug's addressable market. Shares rose 5.5% on the news, building on recent momentum from patent grants and a supply agreement. The company still faces a securities class action lawsuit, but this regulatory win strengthens the commercial narrative.
At the time of this announcement, IBRX was trading at $7.29 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $7.6B. 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 7 out of 10. Source: Benzinga.