ImmunityBio Inc shares were sinking fast on Thursday morning after receiving notice from the US Food and Drug Administration (FDA) that its Biologics License Application was put on hold for its bladder cancer treatment Anktiva.
The FDA determined that the BLA cannot be approved in its current form due to deficiencies found during a pre-license inspection of the company's third-party contract manufacturer.
Shares of the US immunotherapy company plunged over 53% on the news, marking a record one-day selloff.
ImmunityBio stated that it intends to promptly request a meeting with the FDA to address the issues outlined in the letter and establish a response timeline and expressed its commitment to diligently resolving the identified concerns and seeking approval.
Additionally, ImmunityBio's executive chairman, Patrick Soon-Shiong, has agreed to provide $30 million in non-convertible debt financing. The company is also exploring potential partnerships with large biopharmaceutical firms for the commercialization of Anktiva.
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