Will They Or Won't They Approve? FDA Acceptance of Papillary sBLA Sets Up Key Regulatory Catalyst for IBRX in 2027

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Will They Or Won't They Approve? FDA Acceptance of Papillary sBLA Sets Up Key Regulatory Catalyst for IBRX in 2027

May 20, 2026 ImmunityBio

(IBRX, Buy, $12 PT)

Jeet Mukherjee, Ph.D

Will They Or Won't They Approve? FDA Acceptance of Papillary sBLA (332) 400-5178 jmukherjee@btig.com

Sets Up Key Regulatory Catalyst for IBRX in 2027 Blake Gitler

(212) 527-3540 bgitler@btig.com

WHAT YOU SHOULD KNOW: IBRX announced yesterday that the FDA accepted its Company DataBIOTECHNOLOGY sBLA for ANKTIVA + BCG in BCG-unresponsive NMIBC with papillary-only disease, Closing Price $8.05

with a PDUFA date of January 6, 2027. One day prior, the FDA held a workshop with

Price Target $12.00 leading KOLs to discuss similarities and differences between CIS and papillary bladder

cancer, as well as the BCG shortage. We see this sBLA as an intriguing test for the latest Market Cap (M) $8,266.30

Shares Out (M) 1,026.87EQUITY iteration of the FDA. While the FDA clearly calls out its concern for single-arm trials

in papillary-only disease in the sBLA communication, the FDA workshop commentary Avg Daily Vol-3 Months (M) 23.19

and NCCN guideline inclusion of papillary only disease for ANKTIVA + BCG suggest a Revisions

willingness to reconsider established norms in this setting. We also recognize that this

Previous Current is an FDA under increasing pressure to be more favorable toward pts and get drugs to

those who are most in need. These competing forces make benchmarking regulatory Rating Buy Buy

Price Target $12.00 $12.00RESEARCH risk very challenging for this application, and we see chances of approval at 50-50 at

this juncture. The next catalyst for the stock is BCG-naïve data which is on track for CY26E REV 217.14 217.14

~Sept/Oct 2026. CY27E REV 316.50 316.50