MRK - ImmunityBio Lights Up: Anktiva's FDA Nod Shakes Up Bladder Cancer Battle

2024-04-23 11:45:16 ET

Summary

• ImmunityBio, Inc.'s Anktiva approved by FDA for NMIBC, marking the company's first commercial product entry.
• Anktiva faces tough competition from existing treatments and promising therapies in the pipeline.
• ImmunityBio has financial resources for the short-term, but long-term financial health remains uncertain.
• Investment recommendation: Sell ImmunityBio due to high valuation amidst competitive and financial challenges.

Introduction

ImmunityBio, Inc. ( IBRX ) announced today that their IL-15 immunotherapy, Anktiva, was approved by the FDA for the treatment of "BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)." This followed a Complete Response Letter [CRL] from May 2023 citing deficiencies in third-party CMOs. This is a significant milestone for the company, which was founded ten years ago, as it is its first commercial product. The approval followed a trial of 77 patients in which Anktiva inspired a complete response rate [CR rate] of 62% and a duration of response [DOR] of 58% at 12 months....

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