ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data [Yahoo! ...
ImmunityBio, Inc. (IBRX)
Company Research
Source: Yahoo! Finance
The FDA reviewed the additional data provided by ImmunityBio in February 2026, and based on the Agency's feedback, the Company resubmitted the sBLA The FDA has acknowledged receipt of the resubmitted filing The sBLA aims to address the unmet need for patients with papillary-only NMIBC, supported by what is believed to be the longest duration of follow-up and bladder preservation data in this patient population Approximately 60,000 people are diagnosed with NMIBC annually in the U.S., with approximately 70% presenting with papillary (Ta) disease CULVER CITY, Calif. March 9, 2026 /PRNewswire/ -- ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License Application (sBLA) for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.
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News
- ImmunityBio (IBRX) Resubmits sBLA to FDA for ANKTIVA in Papillary Bladder Cancer [Yahoo! Finance]Yahoo! Finance
- ImmunityBio Highlights ANKTIVA Surge, FDA Papillary Filing and Key 2026 Milestones at Conference [Yahoo! Finance]Yahoo! Finance
- ImmunityBio's Anktiva Could See More Upside: My Updated Thoughts On Expansion [Seeking Alpha]Seeking Alpha
- NCCN Guideline Expansion Puts ANKTIVA And ImmunityBio Growth In Focus [Yahoo! Finance]Yahoo! Finance
- ImmunityBio (IBRX) had its "buy" rating reaffirmed by D. Boral Capital. They now have a $23.00 price target on the stock.MarketBeat
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 2/26/26 - Form 4
- 2/25/26 - Form SCHEDULE
- 2/24/26 - Form 4
- IBRX's page on the SEC website