ImmunityBio Inc (NASDAQ:IBRX) shares were up during Monday’s premarket session, but dipped as the company addresses compliance issues raised by the U.S. Food and Drug Administration (FDA).
The FDA issued a warning to ImmunityBio, alleging that the company made unsupported claims that Anktiva could cure or prevent cancer and suggested effectiveness beyond its approved use, including treatment for multiple cancers and use as a standalone therapy.
ImmunityBio subsequently initiated a comprehensive review of all promotional materials and external communications claims with its legal and regulatory teams.
The actions included mandatory executive training, expanded Promotional Review Committee protocols, and the engagement of external regulatory counsel to audit future high-visibility communications.
ImmunityBio has submitted a comprehensive response to the FDA’s Office of Prescription Drug Promotion (OPDP) regarding concerns about a podcast and a television advertisement.
The company confirmed that the television ad was never aired and is implementing corrective actions, including enhanced internal protocols and mandatory executive training.
ImmunityBio Growth Driven By Anktiva Sales Momentum
In March, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for Bladder Cancer.
The agency included Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only disease.
ImmunityBio reported a remarkable year-over-year increase in revenue, driven by the sales of Anktiva.
Sales jumped from $7.56 million to $38.29 million, beating the consensus of $37.02 million.
The company reported a 750% unit sales volume increase for Anktiva.
IBRX Stock Price Activity: ImmunityBio shares were up 0.14% at $7.31 during premarket trading on Monday, according to Benzinga Pro data.
Photo via Shutterstock
Recent Comments