- Botanix holds an exclusive licence for Permetrex™, a direct-to-the-skin drug delivery system.
- FDA denied approval for a treatment for excessive sweating based on confusing packaging instructions.
- Botanix is resubmitting its application, with approval expected in mid-2024.
Eager investors attuned to the company’s promising pipeline of skin treatments from acne to psoriasis welcomed the 7 December 2022 announcement that the US FDA (Food and Drug Administration) placed one of the company’s treatments “formally under review.”
The stock price began a largely uninterrupted upward climb until 19 September 2023, when speculation around the upcoming FDA decision led to an ASX price inquiry. Despite the fall, the Botanix stock price is up 194.64% year over year.
Source: ASX
The crushing news came on 25 September. The FDA response identified one area of concern preventing the agency from approving the Botanix submission – the “Instructions for Use” literature accompanying the product.
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In the announcement, Botanix pointed out the FDA found no “clinical efficacy, safety, pharmacology, non-clinical or manufacturing” issues of concern, nor did the FDA require additional clinical studies.
The company has completed a “Human Factors Study” validating revised instructions. Botanix will complete the resubmission process in Q1 of FY 2024, with approval anticipated in mid-2024.
An analyst at Seneca Financial Solutions has a BUY recommendation on Botanix Pharmaceuticals shares, citing the company’s expected mid-2024 FDA approval for its leading product and the successful capital raise of $13.5 million dollars to support the product launch while cautioning the “stock is more suited for investors with an appetite for risk.”
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