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ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency's Unambiguous Guidance on Jan 2025 to Submit a sBLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter on May 2, 2025

1. ImmunityBio received an RTF letter from the FDA on its sBLA for ANKTIVA. 2. This denial impacts IBRX's prospects in treating NMIBC, raising investor concerns.

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FAQ

Why Very Bearish?

Receiving a Refusal to File (RTF) letter indicates significant regulatory setbacks. Historical instances, like with other biotech firms awaiting drug approvals, have often led to stock declines following similar news.

How important is it?

The RTF signifies a critical setback in IBRX's product pipeline, impacting investor confidence and future revenue potential.

Why Short Term?

The immediate impact from the RTF letter will likely affect IBRX's performance in the near future, as investor sentiments respond quickly to regulatory news.

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CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: 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.

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