secwatch.observer — SEC 8-K summary
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Issuer:     ImmunityBio, Inc. (IBRX)
CIK:        0001326110
Form:       8-K
Filed at:   2024-04-23T23:59:59+00:00
Accession:  0001326110-24-000040
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1326110/000132611024000040/0001326110-24-000040-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1326110/000132611024000040/ibrx-20240422.htm
  HTML page:      https://secwatch.observer/filing/0001326110-24-000040

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