Scynexis to recall GSK-partnered antifungal on cross contamination risk

[September 26, 2023]  By Manas Mishra

(Reuters) -Scynexis said on Monday it would voluntarily recall its antifungal pill, which it has licensed to GSK, due to risk of cross-contamination with a potential allergy-inducing compound, sending the drugmaker's shares tumbling over 30%.

The drugmaker said it became aware substances used to make drugs that contain beta-lactam are manufactured using equipment also used to make its treatment, called Brexafemme.

The U.S. Food and Drug Administration's guidelines require companies to segregate the manufacturing of beta-lactam compounds from other drugs because they may trigger hypersensitivity or an allergic reaction in some people.

Scynexis said the recall was cautionary and that it had not received any report of any adverse events due to possible beta-lactam cross contamination.

It had also placed a temporary hold on clinical studies of the drug until a mitigation strategy and a resupply plan were determined.

Guggenheim analysts estimated it would take "at least several months" for the company to develop a mitigation strategy, resupply the market and resume clinical trials.

The yeast infection pill, which was first approved in 2021, brought in sales of $5 million in 2022. GSK, which licensed the pill from Scynexis in March, had forecast $500 million in peak sales of the drug.

GSK is "continuing to evaluate the situation with Scynexis Inc to determine the next steps," a company spokesperson said.

Up to 75% of women have at least one episode of vulvovaginal candidiasis, commonly known as a vaginal yeast infection, in their lifetimes, according to U.S. government data.

Shares of New Jersey-headquartered Scynexis fell 34.5% to $2.17 in morning trading, paring most of the gains since the GSK deal was announced. It had a market capitalization of roughly $123 million as of Friday's closing price of $3.31.

The FDA did not immediately respond to a request for comment on the recall.

(Reporting by Manas Mishra in Bengaluru and Ludwig Burger in Frankfurt; Editing by Krishna Chandra Eluri)

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