Botanix Pharmaceuticals (ASX:BOT) shareholders have to wait another 12 months for FDA approval

Botanix Pharmaceuticals (ASX:BOT) was hoping to get FDA approval this week, but its hopes were dashed because the FDA wants more information.

Recap of Botanix Pharmaceuticals (ASX:BOT)

The company has a gel that it is trying to get FDA approved for the treatment of primary axillary hyperhidrosis (excessive sweating). It has just entered a trading halt pending an answer from the FDA, expected on or before Wednesday. This would mark 12 months since it made this submission to the FDA, a step taken after successful Phase 3 clinical trials.

Botanix estimates that it has a market of over 7m people in the US alone, which FDA approval would unlock. But it’ll have to wait 9-12 more months.

What went wrong?

Instead of a green light, Botanix received a Complete Response Letter that indicated there was one issue to be clarified before the FDA approved it. Namely, how the patient was instructed to use the product.

The FDA provided some detail as to how it wanted the instructions and ordered the company undertake a human factors validation study to indicate that the revise instructions were capable of being followed.

The company tried to sugar-coat the news by stating that no safety, efficacy, or manufacturing issues were identified. And most importantly, it did not have to conduct a full clinical trial all over again. All this is true, but the company and its investors hoped for FDA approval and it did not get it.

Shares fell by over 25% on Tuesday, following a rally in shares for several months as investors anticipated the green light.

Botanix Pharmaceuticals (ASX:BOT) share price chart, log scale (Source: TradingView)

The company anticipates will complete the resubmission by early next year and will resubmit it to the FDA targeting approval by mid-CY24. And it is anticipated that the company will not require further capital.

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