Botanix News Hub
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Botanix (ASX: BOT) has received a communication from FDA in relation to its NDA submission for Sofpironium Bromide gel, 15% (SB) for the treatment of primary axillary hyperhidrosis.
Encouragingly, no clinical efficacy, safety or manufacturing issues were raised and no additional clinical studies are required by the FDA to support approval. We will be revising the printed Instructions for Use document proposed for inclusion with the product and our team is now focused on working with the FDA to address the points raised, with plans to resubmit the NDA for SB by 1Q CY24 and targeting approval for mid-CY24.
Earlier today Botanix hosted an investor webinar outlining details of the Response Letter from the FDA – and next steps for approval. The team was joined by Mr Dave Clissold, Director of Hyman, Phelps & McNamara – the largest dedicated FDA law firm in the United States advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory matters.
Botanix has announced the promotion of Dr Howie McKibbon to the role of Chief Executive Officer, from his current position as Chief Operating Officer.
Dr McKibbon was also previously Botanix’s Chief Commercial Officer, and brings over 25 years of experience in the pharmaceutical industry to the role. Over the course of his career Dr McKibbon has launched more than 15 branded products, managed over 30 dermatology products, and played a significant role in two of the largest dermatology acquisitions with combined valuations of US$7.8 billion.
Botanix Executive Chairman, Vince Ippolito said:
“I am very pleased to congratulate Howie on his promotion to CEO … His experience and proven track record of success is unsurpassed in medical dermatology and I look forward to working with him in his new role at Botanix.”
FDA review of Sofpironium Bromide remains on track, with approval targeted for the end of September 2023.
Botanix is joining the biotech investment community at the 17th Bioshares Biotech Summit in Hobart this week.
This year’s theme is ‘partnering and financing’, and Botanix Executive Director, Matt Callahan, will be sharing insights into the Company’s progress navigating towards FDA approval for Sofpironium Bromide.
Botanix has been featured in an article by Cheyanne Enciso in The West Australian newspaper, reporting on its A$12.5 million raise via an institutional placement.
Botanix has announced it has secured firm commitments for A$12.5 million via an institutional placement.
Proceeds from this raise will be used to extinguish future milestone and royalty payments linked to Botanix’s lead product, Sofpironium Bromide (SB) – in a move that could save up to $160 million and prime the Company for potential M&A or partnership activity.
Botanix (ASX: BOT) hosted a webinar recently to update investors on the Company’s progress during the FDA review period for its lead product, Sofpironium Bromide.
The webinar was hosted by Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon.
Take a look.