Botanix submits NDA for FDA approval of Sofpironium Bromide

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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.”

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Capital Raise Update

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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.  

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$7.5m Capital Raise

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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.

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