Drug Development

IV formulation of Scynexis’ lead antifungal gets sidelined by the FDA as regulators probe blood clots

Shares of the microcap biotech Scynexis $SCYX were bloodied this evening after the FDA ordered investigators to slam the brakes on any studies of an IV formulation of its lead drug after three healthy volunteers experienced blood clots.

The FDA ordered the halt so regulators could complete a review of all available pre-clinical and clinical data of the IV formulation of SCY-078, an anti-fungal. And its shares quickly plunged 30% on the news. The microcap had a market cap of $78 million at the close, ahead of the sharp drop.

The mild to moderate thrombotic events occurred in three volunteers taking the highest dose of the IV drug. The biotech stated:

The potential contribution of the IV formulation of SCY-078 to these events cannot be ruled out even though rates of thrombotic events due to intravenous catheters reported in the literature are comparable to those observed in the Phase I study.

Scynexis planned its IPO in 2014 around this drug, looking to treat infections linked to the Candida and Aspergillus pathogens, which account for the lion’s share of invasive fungal ailments in the US.

The oral formulation of the drug remains on track and company execs plan to meet with FDA officials in the second quarter.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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