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On September 25, 2023, in a filing with the U.S. Securities and Exchange Commission, SCYNEXIS reported that, following a recent review of the manufacturing process for its ibrexafungerp drug substance and the equipment at the manufacturing vendor for ibrexafungerp, the Company became aware of potential cross contamination of ibrexafungerp with a non-antibacterial beta-lactam drug substance. As SCYNEXIS explained, “FDA guidance recommends segregating the manufacture of beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people.”
The Company therefore declared it would recall the ibrexafungerp tablets commercially known as BREXAFEMME from the market and place a temporary hold on clinical studies of ibrexafungerp, including a Phase 3 clinical study, until a mitigation strategy and a resupply plan are determined.
On this news, SCYNEXIS’s stock price fell 34.14%, to close at $2.18 per share on September 25, 2023.