Final Sofdra™ Labelling Discussions with FDA

Botanix has submitted the last label materials to the US Food & Drug Administration (FDA) for Sofdra™ a pending prescription treatment for excessive underarm sweating. Label discussions are the final step for Botanix before the anticipated FDA approval of Sofdra and have involved product carton design and wording of information that is provided to patients and physicians about the product.

Click here to view ASX release.

“Compelling Opportunity” | E&P Research Report

In new research on Botanix, leading biotech analyst David Nayagam from E&P highlights the “compelling opportunity” that the Company presents and initiates coverage with a speculative buy and $0.55 price target. This increased interest in Botanix comes at a critical time, as we await the commencement of labelling discussions with the FDA – the final regulatory hurdle for Sofdra™ before expected approval in late June 2024.

View E&P Report.

Euroz Hartleys Analysis | Commercial Day Webinar

Euroz Hartleys’ Seth Lizee reviews the Botanix Commercial Day Webinar and maintains a Speculative Buy recommendation with an upgraded $0.33 Price Target.

Lizee expressed increased confidence in the late June FDA approval decision and BOT’s commercial strategy.

Click here to read the report.

Video Available | Commercial Day Webinar

Video is now available of the Company’s Commercial Day Webinar presented on 8 May.

The expanded commercial team provides market insights and a comprehensive update on commercial launch plans for Sofdra™, which is expected to be approved in late June 2024.

Botanix Included in the All Ordinaries Index

Botanix Pharmaceuticals (ASX:BOT) is honoured to announce the Company’s inclusion in the ASX All Ordinaries Index. Botanix joins the ranks of the index, based on its strong performance over the last 12 months.

Botanix Chief Executive Officer, Howie McKibbon, commented: “We are humbled to acknowledge the confidence investors have shown in our company, as exemplified by our inclusion in the ASX All Ordinaries Index.”

The performance of Botanix shares has been driven by interest in the Company’s Sofpironium Bromide gel, Sofdra™, which is a topical treatment for excessive underarm sweating that is expected to receive approval from the US FDA in late June. Botanix launch preparations are well underway.

Click here to read today’s ASX release.

The West Australian | Botanix co-founder Matt Callahan says zig-zag career like ‘drinking from a firehose’

Botanix co-founder and executive director Matt Callahan has been profiled in The West Australian this week, in an article by journalist Cheyanne Enciso titled “Botanix co-founder Matt Callahan says zig-zag career like ‘drinking from a firehose’ “.

The feature outlines Matt’s extensive experience as founder of several ASX-listed companies, and shares his insights into what makes a successful company.

I think the strongest lesson for me is to work with people who are world class and be prepared to learn from them, be prepared to build networks with people that ultimately can create a great company.”

Click here to read the article.

Botanix appoints Graeme Morissey CFO

Botanix Pharmaceuticals (ASX:BOT) is pleased to announce the appointment of Graeme Morissey as Chief Financial Officer (“CFO”) of the Company effective 25 March 2024. Mr Morissey joins Botanix as a proven CFO with over 17 years’ experience with senior roles at international accounting firms including Grant Thornton in Canada and Australia, as well as KPMG Australia and EY Australia. Graeme has worked with more than 40 ASX listed companies supporting audit and other financial functions and most recently has occupied CFO positions at a number of ASX listed companies.

Mr Morrisey joins Botanix at an important time for the company as it prepares for commercial launch of Sofdra™ early in 3Q CY2024 following anticipated approval of the product in late June. As the commercial team accelerates activities focused on sales and marketing operations, reporting and tax planning, Graeme’s wealth of experience will be important to help coordinate Australian and US reporting and compliance.

Click here to read today’s ASX release.

Botanix resubmission of NDA for Sofdra™ accepted

Botanix Pharmaceuticals has today announced the Company’s resubmission of the new drug application (NDA) for Sofdra™ has been accepted as a complete response by FDA. FDA also confirmed that the resubmission of the Sofdra NDA is a Class 2 response (i.e., a 6-month review period from the resubmission in late December 2023), with the result that approval remains on target for late June 2024.

Botanix CEO, Dr Howie McKibbon, said:

“We are pleased that FDA has confirmed that the resubmission of the Sofdra NDA is acceptable as a complete response and that the anticipated approval date in late June 2024 remains on target.

“This clarity means that our commercialisation activities in preparation for launch can be appropriately designed to ensure a rapid launch of Sofdra, following successful approval from FDA.”

Click here to read the ASX release.

Botanix resubmission of NDA for Sofdra™ completed

Botanix Pharmaceuticals has announced that the Company has successfully completed resubmission of the new drug application (NDA) for Sofdra™.  FDA approval for Sofdra is now targeted for late 2Q 2024.

The NDA resubmission follows successful completion of the human factors validation study that assessed revised Instructions for Use (IFU) for Sofdra.

Botanix CEO, Dr Howie McKibbon, said:

“We are pleased to advise that the resubmission of the Sofdra NDA has been completed well ahead of schedule, and I am very appreciative of the effort the Botanix team has exerted over the last few months to achieve this earlier than expected filing.

“Our focus now is firmly on preparation for commercialisation as we work with FDA towards Sofdra approval by midyear.”

Click here to read the ASX release.

Successful completion of human factors validation study assessing revised Instructions for Use for Sofdra™

Botanix Pharmaceuticals has announced that the Company has successfully completed the planned human factors validation study assessing revised Instructions for Use (IFU) for Sofdra™.

All HF Study participants successfully prepared and applied Sofdra in accordance with the revised IFU, and both users and caregivers successfully completed the use-related tasks.

Botanix CEO, Dr Howie McKibbon, said:

“We are very pleased with the outcome of the HF Study for Sofdra and the performance of the revised IFU in guiding patients to the safe and successful use of the product.

“The team will continue working over the holiday break to expeditiously assemble materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”

Botanix will now prepare to resubmit the Sofdra new drug application to FDA in 1Q CY2024, targeting FDA approval in mid-CY2024.

Click here to read the ASX release.