By Colin Kellaher
Scynexis shares slid more than 30% on Monday after a potential cross-contamination issue prompted the biotechnology company to recall its FDA-approved antifungal products and place a late-stage study on hold.
Shares of the Jersey City, N.J., company were down 32% to $2.24.
Scynexis, which earlier this year granted U.K. drug giant GSK an exclusive license to its antifungal compound ibrexafungerp, including the approved product Brexafemme, said a review by GSK of the vendor that makes the ibrexafungerp drug substance found a risk of cross contamination with a compound that could cause a hypersensitivity or an allergic reaction in some people.
GSK made an upfront payment of $90 million to Scynexis as part of the agreement, and Scynexis reported second-quarter revenue of nearly $131 million related to the licensing deal.
Brexafemme is FDA-approved for treatment of patients with vulvovaginal candidiasis, also known as vaginal yeast infection, and for the reduction in the incidence of recurrent vulvovaginal candidiasis. The compound is also in a Phase 3 study in invasive candidiasis.
Scynexis said it is conducting the recall and placing the study hold while it develops a mitigation strategy and a resupply plan.
Write to Colin Kellaher at [email protected]
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