Scynexis Shares Fall More Than 30% After Brexafemme Recall >SCYX

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]


Read the full article here