ImmunityBio Says Steps Taken to Address FDA Concerns Over Anktiva Podcast, TV Ad

MT Newswires Live04-06

ImmunityBio (IBRX) said Monday that it has removed a podcast about its bladder cancer drug Anktiva from its website and asked third-party hosting platforms to remove the podcast to address the US Food and Drug Administration's concerns.

The company also said the television ad questioned by the regulator never aired.

In addition, ImmunityBio said it is executing other measures to improve advertising compliance, including expanded promotional review protocols and mandatory executive training.

In March, the FDA issued a warning letter to the company citing "false or misleading" promotional materials for Anktiva.

Anktiva, or nogapendekin alfa inbakicept-pmln), is indicated in combination with Bacillus Calmette-Guerin for the treatment of adults with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ with or without papillary tumors, the regulator said.

Shares of ImmunityBio were up 1.2% pre-bell Monday.

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