By Colin Kellaher
Shares of Scynexis tumbled in premarket trading Monday after the biotechnology company said it is recalling its antifungal medication Brexafemme from the market and placing a hold on studies of the compound due to a potential cross-contamination issue.
The Jersey City, N.J., company said the issue came to light following a review by partner GSK of the manufacturing process and equipment at the vendor that makes Brexafemme’s key ibrexafungerp drug substance.
Scynexis said the review found that the vendor uses the same equipment to make ibrexafungerp and a non-antibacterial beta-lactam drug substance despite U.S. Food and Drug Administration guidance that recommends segregation because beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people.
Scynexis said it doesn’t know if any ibrexafungerp has been contaminated and that it has no reports of any adverse events, but the company said it is implementing the recall and study hold out of an abundance of caution and on the advice of GSK, which earlier this year inked an exclusive license agreement with Scynexis for Brexafemme.
The company said the recall and study hold are in place until a mitigation strategy and a resupply plan are determined.
Scynexis shares, which closed Friday at $3.31, were recently down nearly 37% premarket to $2.10.
Write to Colin Kellaher at [email protected]
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