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Wednesday, Dec 6, 2023

FDA to Study ImmunityBio Cancer Drug

Investors in Culver City-based immunotherapy company ImmunityBio Inc. have recently been buoyed by the company’s announcements that it resubmitted – and the Food and Drug Administration has accepted – its application for review of its lead drug candidate to treat a type of bladder cancer.

In accepting ImmunityBio’s application, the federal agency set a target date of April to complete its review of the drug; if the agency gives its approval, the drug could be ready for commercial use – the first to hit the market for the company founded by billionaire Patrick Soon-Shiong nearly a decade ago as part of his immunotherapy approach to combatting cancer.

Back in May, the federal agency rejected ImmunityBio’s initial application for the drug – called Anktiva – citing concerns about the third-party manufacturing process, among other things. That caused ImmunityBio’s stock to plunge nearly 60%.

ImmunityBio announced on Oct. 23 that it had resubmitted the drug application, including a wide array of additional test and clinical trial results. 

Within days, the FDA accepted the resubmission for review. Furthermore, the agency gave a target date of April 24 for completion of its review. That date is not set in stone, however, as the agency could request additional data.

“We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA (biologics license application) … following our productive interactions leading up to the resubmission,” Soon-Shiong said in the company’s second announcement. 

Soon-Shiong is executive chairman and global chief scientific and medical officer for ImmunityBio. He is also by far the company’s largest investor; his 372 million shares give him a 77% stake.

The company’s other investors sent shares rocketing up. In the six trading days following the news of the new drug application resubmission – and including the agency’s acceptance of that application – the share price rose 137% to $3.08. 

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