Scynexis Inc (NASDAQ:SCYX) is voluntarily recalling its antifungal pill, Brexafemme (ibrexafungerp), from the market and placing a temporary hold on clinical studies of ibrexafungerp, including the Phase 3 MARIO study, until a mitigation strategy and a resupply plan are determined.
The yeast infection pill was first approved in 2021.
The move follows the risk of cross-contamination with a potential allergy-inducing compound.
The FDA approved Brexafemme for vulvovaginal candidiasis (VVC) and reduced the incidence of recurrent VVC (RVVC).
Scynexis became aware that a non-antibacterial beta-lactam drug substance is manufactured using equipment common to the manufacturing process for ibrexafungerp.
Current 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 March this year, GSK plc (NYSE:GSK) and Scynexis entered an exclusive license agreement for Brexafemme for an upfront payment of $90 million.
Price Action: SCYX shares are down 34.40% at $2.17 on the last check Monday.
