Botanix gets FDA response letter on sofpironium bromide

26 September 2023

Australian dermatology company Botanix Pharmaceuticals (ASX: BOT) today revealed it has received a communication from the US Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) submission for sofpironium bromide (SB) gel, 15%.

The news pushed Botanix’ shares down more than 22% to A$0.14 by close of trading today.

Botanix’ lead product is in development for the treatment of primary axillary hyperhidrosis, a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.

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