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id: 716, Created by Stan Vick, Scout
ImmunityBio (IBRX) Anktiva Misleading Case
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21 May 2022Class period Start
10 May 2023Class period End
- ImmunityBio disclosed that FDA didn't approve the BLA for Anktiva due to manufacturing deficiencies.
- $IBRX fell over 55% and lost $1.5B of its market capitalization.
- Investors suspect ImmunityBio & its Leaders of misleading.
On May 11, 2023, ImmunityBio (IBRX) disclosed that it received a complete response letter from the FDA regarding its Biologics License Application (BLA) for its product candidate Anktiva (N-803) indicating that the FDA has determined that it cannot approve the BLA in its present form based on “deficiencies related to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations” and that “satisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved.”
On this news, $IBRX fell over 55% and lost around $1.5 billion of its market capitalization, seriously damaging investors.
Taking all facts and market reaction into account, Investors may have reasons to suspect ImmunityBio and its Leaders of misleading and failing to disclose correct information about the manufacturing conditions of its product candidate, specifically failing to disclose that the Company conducted insufficient due diligence to discover, or else did discover and ignored, good manufacturing practice deficiencies at its third-party contract manufacturing organizations for Anktiva, which led the U.S. Food and Drug Administration to reject the Anktiva Biologics License Application.
Failure to Disclose,
Shock Event Date
11 May 2023
30 June 2023
Lead Plaintiff Deadline
29 August 223
Hon. Roger T. Benitez