ImmunityBio gets FDA approval for ANKTIVA in BCG-unresponsive NMIBC; CR rate 62%, DOR >47 months

ImmunityBio, Inc.

FDA approved ANKTIVA (N-803) plus BCG for BCG-unresponsive NMIBC with CIS on April 22, 2024.
Complete response rate of 62% in evaluable patients; duration of complete response >47 months and ongoing.
58% of patients had DOR ≥12 months, 40% had DOR ≥24 months; median DOR not yet reached.
ANKTIVA expected to be available in U.S. by mid-May 2024; conference call April 26 at 11am EDT.
Company plans to seek approval to increase shares under 2015 Equity Incentive Plan by up to 19.9M shares.

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