According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- Checkpoint had overstated its oversight of, and/or its establishment of adequate manufacturing standards and controls over, its third-party contract manufacturers;
- accordingly, there were one or more issues with Checkpoint’s third-party contract manufacturing organization (“CMO”) for cosibelimab, Checkpoint’s lead antibody product candidate;
- all the foregoing reduced the likelihood that the Federal Drug Administration would approve the cosibelimab Biologics License Application (“BLA”) in its present form;
- as a result, the manufacturing, regulatory, and commercial prospects of cosibelimab were overstated; and
- as a result, Checkpoint’s public statements were materially false and misleading at all relevant times.
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