Botanix submits NDA for FDA approval of Sofpironium Bromide

/in , , /by

Botanix has today announced the submission of a New Drug Application to the FDA for approval of Sofpironium Bromide for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating).

Phase 3 studies of Sofpironium Bromide showed very high statistical significance for the treatment of primary axillary hyperhidrosis. In the US alone, there are approximately 7.3 million people who suffer from this disorder, with more than half of them actively seeking treatment.

Botanix President and Executive Chair, Vince Ippolito, said:

“We are delighted with the achievement of this submission milestone, and are targeting FDA approval in the US for 4Q CY2023 (following the usual 12-month FDA assessment and review period) to enable the commencement of sales in the US market.”

Click here to view ASX release

Capital Raise Update

/in , , /by

Botanix has announced it has now closed the first tranche of its anticipated $7.5 million placement to new and existing institutional and sophisticated investors.

The second tranche of the Placement is an issue of New Shares to Botanix directors, who have  committed to subscribe for a total of $0.5 million of New Shares, which is subject to shareholder approval.  

Click here to view ASX release

$7.5m Capital Raise

/in , , /by

Botanix has today announced it has received strong commitments to raise $7.5m through a placement to Australian and international institutions and sophisticated investors.

Funds will support the development of the Company’s lead asset – Sofpironium Bromide (SB) – a novel dermatology asset with positive Phase 3 data to treat primary axillary hyperhidrosis, a medical condition which results in excessive underarm sweating.

This will include support for the FDA approval process and preparation for commercial launch. The New Drug Approval (NDA) filing with the FDA remains on track for submission this quarter with a 12-month review process.

Click here to view ASX release

Research Report by Euroz Hartleys – 17 August 2022

/in , , /by

Botanix (ASX:BOT) is pleased to advise that leading adviser Euroz Hartleys has released an analysis outlining the strong market opportunities for our most recent asset acquisition, Sofpironium Bromide.

Within the report, analyst Seth Lizee commented:

“Sofpironium Bromide’s target patient population is estimated to be ~3.7 million people in the United States, equal to the estimated number of patients with severe axillary hyperhidrosis seeking treatment…Even modest market penetration can translate into significant revenues.”

Read the full report.

Euroz Hartleys Report | 7 July 22

/in , , /by

Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company announcement that the FDA filing timeline for Sofpironium Bromide had been accelerated.

Click here to view the report.

NDA filing accelerated and trials fully enrolled

/in , /by

Botanix has today announced the New Drug Approval (NDA) submission to the FDA for our recently acquired dermatology asset, Sofpironium Bromide for the treatment of excessive underarm sweating, will now be ready to file in Q3 2022.

The Company also provided an update on its pipeline clinical studies. Both the rosacea (BTX1702) Phase 1/2 clinical study and the canine dermatitis (BTX 1204A) pilot study have reached target enrolment numbers, and subjects will be completing their treatments over the coming weeks. Outcomes for these two studies are expected later in the year.

Click here to view ASX release and presentation.

Euroz Hartleys Report | 22 June 2022

/in , , /by

Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the acquisition of our dermatology asset Sofpironium Bromide.

Click here to view the report.

Herald Sun + Daily Telegraph | Sofpironium Bromide Story

/in , /by

🗞 MAKING HEADLINES

Herald Sun Reporter, Owen Leonard, met with Botanix executives while they were in Australia this week and has published a story about the Company’s recent acquisition of Sofpironium Bromide.

This novel potential treatment for primary axillary hyperhidrosis, a medical condition that results in excessive underarm sweat, is bringing new hope for sufferers.

Botanix Executive Director, Matthew Callahan, explained why it could fill a market gap:

“At the moment, to treat it, you’ve got a couple of options. You’ve got antiperspirants – covers up the smell but does nothing to actually have an effect on the excessive sweating – and at the other extreme, you’ve got surgery, where they’ll actually go in and cut the nerve to stop the signals getting to the sweat gland to stop you sweating excessively.

“In between, there’s been a lot of drugs that have been around for decades that don’t work very well and have all sorts of nasty side effects.”

Click here to read the story.

Euroz Hartleys Report | ‘Transformational Acquisition’

/in , /by

Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the Company’s recent acquisition of Sofpironium Bromide.

The deal has been called a “transformational acquisition”.

Click here to view the report.

Euroz Hartleys Report | 4 May

/in , , /by

Botanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the acquisition of our dermatology asset Sofpironium Bromide.

Click here to view the report.