ImmunityBio’s Marketing Application for Bladder Cancer Medication Shot Down by FDA

ImmunityBio took a loss today after receiving news its marketing application for its bladder cancer drug Anktiva was rejected by the US Food and Drug Administration (FDA). The decision came primarily because of issues with manufacturing facilities. The agency also wants more safety data and information on the duration of treatment response.

According to Phil Taylor, “If the issues were confined to CMC, the delay could be expected might be fairly short, but the other requests rattled investors who were trying to gauge the impact of the decision, given that ImmunityBio is running low on cash reserves. Shares were down around 56% at the time of writing. The company indicated that it was seeking a meeting with the FDA to get a fuller understanding of what is required and will refile for approval as quickly as possible.”

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(Source: Pharmaphorum, May 11^th, 2023)