Botanix Pharmaceuticals (ASX:BOT) shares plummeted as much as 36.1% to A$0.115, hitting their lowest level since late June.

The stock’s 27.8% downturn potentially marks its worst trading day since March 25, 2020.

The dermatology-focused company received a Complete Response Letter from the U.S.

Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for Sofpironium Bromide gel, a treatment for excessive sweating.

The company plans to correspond with the FDA and perform principally minor tasks needed to elucidate product use instructions.

The company aims to refile the NDA in early Q1 CY2024, targeting a mid-CY2024 approval.

Based on their communication with the FDA, the company does not anticipate any new review issues as part of the resubmission review process.

An overwhelming 12.5 million shares have been traded, more than tripling the 30-day average volume of 3.8 million shares.

Prior to this dramatic drop, the company’s stock had tripled in value this year.

Botanix Pharmaceuticals (ASX:BOT) is a dermatology company specializing in the development of therapeutic gels.