This ASX cannabis stock is up 160% since June, and it has an FDA ruling coming up!

Investors are very excited about this cannabis stock.

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The Botanix Pharmaceuticals Ltd (ASX: BOT) share price hit a 52-week high of 21 cents this morning before giving back its gains and dropping into the red.

When the ASX cannabis stock hit that level, it meant it was up a massive 160% since the start of June.

This strong gain caught the eye of the ASX operator, which sent it in price query today.

Why is this ASX cannabis stock on smoking the market?

Botanix was asked if it was "aware of any information concerning it that has not been announced to the market which, if known by some in the market, could explain the recent trading in its securities?"

The answer to this question was simply no. However, it did then attempt to explain why it thinks investors have been scrambling to buy the ASX cannabis stock recently.

It suggested the following could be driving its shares higher:

As previously announced by the Company to the ASX, including most recently in its Preliminary Final Report released on 31 August 2023, the Company's lead product, Sofpironium Bromide, is awaiting decision from the FDA, which is anticipated to be received in late September 2023. The Company notes that if FDA decision is received, it will represent a significant milestone for the Company, as it will pave the way for an expansion of the Company's operations and revenue generation.

What is Sofpironium Bromide?

Botanix's Sofpironium Bromide is the first and only new chemical entity developed to treat primary axillary hyperhidrosis. It is a medical condition that results in excessive underarm sweating.

While the company's focus has been on cannabis in the past, this product is actually an anticholinergic/antimuscarinic drug that blocks sweating at the gland by binding to the receptor and thereby blocking the sweat signal.

In the US alone, there are approximately 10 million patients who suffer from primary axillary hyperhidrosis. Approximately 3.7 million of those are already actively seeking treatment.

The company notes that Sofpironium Bromide has achieved statistical significance in all primary and secondary endpoints and was found to have a favourable safety profile in Phase 3 pivotal studies and in a 48-week safety study.

Management believes the product is positioned to be a leading first-line and second-line therapy and potentially represents a safe and effective new option for patients.

Stay tuned for the FDA update later this month.

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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