ImmunityBio converts from Immunomedics Message Board

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Biotech / Medical : ImmunityBio converts from Immunomedics

IBRX 2.110

-1.4%

Nov 6 3:59 PM EST

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To: TinfoilHat who wrote (983)	5/5/2025 6:45:24 AM
From: luckydog88	1 Recommendation Recommended By Fitzhughlaw Read Replies (1) of 1229

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc.(IBRX) , a leading immunotherapy company, today announced that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. This RTF letter was received despite reaching unanimous guidance and encouragement at the in-person January 2025 meeting from the leadership of the Agency, including from CBER, CDER and OCE to submit this sBLA. At this meeting all key decision makers were specifically asked and unanimously confirmed that ImmunityBio(IBRX) should submit the sBLA as soon as possible based on the data in the single-arm trial. Relying on this unanimous guidance the Company submitted the sBLA in March 2025. The Company has already requested an urgent meeting to resolve the inconsistencies between the directives provided at the January Meeting and receipt of the RTF letter.

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