Scynexis Inc 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 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.
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