The All Ordinaries Index (ASX: XAO) is up 0.1% in morning trade today, but this ASX All Ords stock isn't going anywhere just yet.
Shares in the clinical dermatology company closed at 34 cents apiece yesterday, which sees the stock up almost 18% in five days.
Today shares in the ASX All Ords stock entered a trading halt pending a key approval announcement from the United States Food & Drug Administration (FDA). Shares are expected to resume trading this Friday.
Any guesses?
If you said Botanix Pharmaceuticals Ltd (ASX: BOT), go to the head of the virtual class.
Here's what's happening.
Image source: Getty Images
What's happening with the ASX All Ords stock?
Last Wednesday, 12 June, Botanix announced that it had submitted the last label materials to the FDA for its prescription product Sofdra. Sofdra is developed to treat excessive underarm sweating. Also known as primary axillary hyperhidrosis, for our medically inclined readers.
That announcement saw the ASX All Ords stock charge higher over the next three trading days.
Investor enthusiasm looks to have been piqued by the company noting that its labelling discussions present the final step before the "anticipated FDA approval of Sofdra". Botanix said its been in discussions with the FDA on product carton design and the wording of information to be provided to patients and physicians about Sofdra.
Commenting on the anticipated approval that sees the ASX All Ords stock in a trading halt today, Botanix CEO Howie McKibbon said:
Our team has been highly focused on completing these last label components, well in advance of approval.
Our label and packaging materials are an important part of the materials that we will use to communicate important safety and efficacy information upon approval of Sofdra.
The company said that FDA approval for Sofdra remains on target for this Friday, 21 June. Upon approval, it said that Sofdra will be the first new chemical entity approved for excessive underarm sweating.
Atop of Sofdra, the ASX All Ords stock has a range of other products in late-stage clinical development to potentially treat a variety of dermatology conditions.
Botanix share price snapshot
If you look back to the chart up top, you'll see just how strong the Botanix share price has performed over the past months.
In 2024 alone, the ASX All Ords share has gained 76%.
Investors who bought shares 12 months ago will be sitting on gains of 205%.
And savvy investors who bought shares at the very end of 2022 (30 December) will have seen those shares rocket by 570%.
