0 seconds of 38 secondsVolume 0%
Press shift question mark to access a list of keyboard shortcuts
00:00
00:38
00:38
 
The Market Online - At The Bell

Join our daily newsletter At The Bell to receive exclusive market insights

  • Botanix Pharmaceuticals (BOT) submits a new drug application (NDA) to the US FDA for the use of its sofpironium bromide gel for patients with severe primary axillary hyperhidrosis
  • The company says it is targeting FDA approval for the fourth quarter of 2023, provided the application follows a typical 12-month assessment and review period
  • The FDA filing comes after Botanix’s sofpironium bromide product was approved for sale in Japan, with “outstanding” early sales already achieved, according to the company
  • The company says it will now look for other opportunities to bolster its product pipeline with more late-stage or revenue-producing dermatology products
  • Shares in Botanix are up 6.45 per cent to 6.6 cents at 11:01 am AEST

Botanix Pharmaceuticals (BOT) has submitted a new drug application (NDA) to the FDA for the commercial sale of its sofpironium bromide gel.

The gel is designed to treat primary axillary hyperhidrosis, which Botanix said affected over seven million people in the US alone.

The company said it was targeting FDA approval for the product in the fourth quarter of 2023, provided the application followed a typical 12-month assessment and review period.

The submission follows successful results from Botanix’s phase three trials of the product, which demonstrated “highly statistically significant clinical efficacy and excellent safety”.

Moreover, the product has already been approved for sale in Japan, with “outstanding” early sales already achieved.

Botanix President and Executive Chair Vince Ippolito said the FDA submission was a milestone for the company.

“Approximately 7.3 million people in the US suffer from hyperhidrosis and have the potential to benefit from sofpironium bromide,” Mr Ippolito said.

“We look forward to working closely with the FDA on the approval of sofpironium bromide.”

The company said looking ahead, it now planned to pursue other opportunities to bolster its product pipeline with additional late-stage or revenue-producing dermatology products.

Earlier this month, the company raised $7.5 million via a share placement to fund the costs associated with the sofpironium bromide FDA filing.

Shares in Botanix were up 6.45 per cent to 6.6 cents at 11:01 am AEST.

BOT by the numbers
More From The Market Online
The Market Online Video

ASX Market Close: RBA rate cut hype absent; bank stocks’ crown teetering

Good afternoon. I’m Jonathon Davidson with HotCopper’s Market Close for Thursday 20th of Feb.
Magnum Mining worker grinding US steel.

Trump uplifts US steel industry with latest tariffs

Donald Trump’s recent announcement that steel and aluminium imported into the United States would now be subject to tariffs of 25% has caused
A logo page that reads Hotcopper Podcast on a stylised market background.

Listen: HotCopper Podcast 001 – HotCopper joins the podcasting game

Welcome to the first HotCopper market-watch podcast! Each week, HotCopper takes you through all the week's…
A logo page that reads Hotcopper Podcast on a stylised market background.

Listen: HotCopper Podcast 002 – The RBA has finally got the scissors out

This week's HotCopper market-watch podcast takes you through all the week's biggest news headlines – and…