Botanix Pharmaceuticals share price on watch amid FDA news and 'transformative event'

Big news has just been announced from this clinical dermatology company.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price will be one to watch closely this week.

That's because the clinical dermatology company has just announced some very big news..

Why is the Botanix Pharmaceuticals share price on watch?

This morning, the company released a highly anticipated announcement relating to its Sofdra product.

According to the release, the US Food and Drug Administration (FDA) has approved Sofdra as a prescription medicine used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and older.

This FDA approval was supported by results from two pivotal Phase 3 studies evaluating its efficacy and safety in 701 patients with the condition.

Management notes that this makes it the first and only new chemical entity approved by the FDA to treat primary axillary hyperhidrosis and presents a novel safe and effective solution for patients who have lacked treatment options for this socially challenging medical condition.

There is a larger addressable market for this than you might think. Botanix highlights that there are approximately 10 million people in the United States with primary axillary hyperhidrosis, with few effective treatments available for patients.

What now?

Management advised that it plans to launch its patient experience program in the first quarter of 2024. After which, it is anticipating its first revenue from Sofdra early in the fourth quarter of the year.

Botanix's chief executive officer, Dr Howie McKibbon, was very pleased with the news and described it as a "transformative event" for the company. He commented:

We are pleased to share this accomplishment with our dedicated Botanix team and dermatologist partners, patients who participated in the clinical studies and our shareholders who made this approval possible. This is a transformative event for Botanix as we transition from a development stage to a revenue generating dermatology company.

This sentiment was echoed by the company's executive chairman, Vince Ippolito. He said:

We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States. As the first and only new chemical entity, Sofdra represents a new therapeutic approach for dermatologists to treat patients with this disabling medical condition.

Capital raising

The Botanix Pharmaceuticals share price will remain in its trading halt despite the release of this announcement.

This is because it is looking to leverage this good news to raise capital from investors. It said:

The Company will remain in halt pending an announcement of the results of a potential capital raising, which is expected no later than opening of trading on Friday, 21 June 2024.

The Botanix Pharmaceuticals share price is up 204% in 12 months.

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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