ImmunityBio swamped by class actions IBRX (N-893 + BCG) is swamped by class actions regarding the May 2023 CRL from the FDA regarding manufacturing issues.
Note that TLT cannot have such manufacturing issues as it is molecule is a small molecule that falls under a NDA, not a BLA. BLA require strict manufacturing inspections by the FDA as it is a much more complex/sensitive one.
What are the Regulatory Differences Between an NDA and BLA?
https://www.allucent.com/resources/blog/what-are-regulatory-differences-between-nda-and-bla#:~:text=To%20formally%20request%20approval%20to,to%20traditional%20small%20molecule%20drugs.
To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs.
About IMMUNITYBIO class actions. One of many:
https://stockhouse.com/companies/news?symbol=ibrx
Class Period: May 23, 2022 - May 10, 2023
The complaint alleges that Defendants made false and misleading statements and failed to disclose that:
(1) ImmunityBio conducted insufficient due diligence to discover, or else discovered and ignored, GMP deficiencies at its third-party contract manufacturing organizations ("CMOs") for Anktiva;
(2) one or more of the company's third-party CMOs for Anktiva did in fact suffer from GMP deficiencies;
(3) the deficiencies were likely to cause the FDA to reject the Anktiva BLA in its present form; and
(4) accordingly, ImmunityBio overstated the regulatory approval prospects for the Anktiva BLA.
Investors learned the truth on May 11, 2023, when ImmunityBio announced the FDA had rejected the BLA in its present form, disclosing that "the deficiencies relate to the FDA's pre-license inspection of the Company's third-party contract manufacturing organizations."
This news drove the price of ImmunityBio shares crashing 55% lower on May 11, 2023.