According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination;
- SCYNEXIS did not have effective internal controls and procedures, as well as adequate internal oversight policies to ensure that its vendor complied with current Good Manufacturing Practices (cGMP);
- due to the substantial risk of cross-contamination, SCYNEXIS was reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and
- as a result of the foregoing, defendants’ positive statements about SCYNEXIS’ business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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