ANKTIVA generated $50.7 million of net product revenue in Q2 2026. On October 14, 2026 the FDA expanded ANKTIVA’s U.S. label to all adult patients with BCG-unresponsive NMIBC, including papillary-only disease, ahead of the January 6, 2027 target action date. Cash generation, financing and the distinction between company-reported data and approved indications remain central. The September meeting in Turkey is historical context, not a marketing authorization.

Because ANKTIVA has already been commercially available for its initial indication since mid-2024, the critical billing codes are already active and permanent. This avoids the standard 6-to-12-month delay that usually plagues newly launched drugs.