By Shares of Scynexis, a biotechnology company based in Jersey City, N.J., plunged in premarket trading on Monday after announcing a recall of its antifungal medication, Brexafemme. The recall is due to a potential issue with cross-contamination and has prompted the company to also put a hold on studies of the compound.
The problem came to light during a manufacturing process and equipment review conducted by partner GSK, who discovered that the vendor responsible for producing Brexafemme’s key drug substance, ibrexafungerp, was using the same equipment to manufacture another non-antibacterial beta-lactam drug substance. This goes against guidance from the U.S. Food and Drug Administration (FDA), which recommends segregation due to the potential for beta-lactam compounds to trigger hypersensitivity or allergic reactions in some individuals.
At this time, it is unknown whether any ibrexafungerp has been contaminated, and there have been no reports of adverse events. However, as a precautionary measure and following GSK’s advice, Scynexis has decided to issue the recall and hold on studies. Earlier this year, GSK signed an exclusive license agreement with Scynexis for Brexafemme.
The recall and study hold will remain in effect until a mitigation strategy and resupply plan are established. Scynexis shares, which closed at $3.31 on Friday, have dropped nearly 37% to $2.10 in premarket trading.
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