Final Sofdra™ Labelling Discussions with FDA
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix 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.
Botanix Included in the All Ordinaries Index
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix 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.
Botanix appoints Graeme Morissey CFO
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix 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.
Botanix to Present at Euroz Hartleys Institutional Conference
/in ASX Releases, Featured, News /by Haley ChartresBotanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO Dr Howie McKibbon will be among the featured presenters tomorrow at the annual Euroz Hartleys Institutional Conference being held March 12–14 on Rottnest Island. Also participating from Botanix is Executive Chairman Vince Ippolito who will take part in a panel discussion with Australia-based life science companies.
The Conference brings together institutional and sophisticated investors from around Australia and internationally to showcase small to mid-cap companies with a Western Australian focus. Botanix will provide an update on progress towards commercialisation of Sofdra™, which remains on track for FDA approval in late June 2024, as launch readiness activities accelerate.
Euroz Hartleys Healthcare Forum Presentation
/in ASX Releases, Featured, News /by Haley ChartresBotanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO, Dr Howie McKibbon, is presenting at the Euroz Hartleys Healthcare Forum being held today in Perth, Western Australia.
The Conference brings together some of Australia’s leading listed and private healthcare companies, as well as institutional investors from around Australia and the region. Botanix will be outlining the significant commercial potential of Sofdra and sharing some of the launch preparation activities that are currently scaling up in anticipation of FDA approval which is targeted for late June 2024.
Botanix resubmission of NDA for Sofdra™ accepted
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix 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.”
Botanix resubmission of NDA for Sofdra™ completed
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix 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.”
Successful completion of human factors validation study assessing revised Instructions for Use for Sofdra™
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix 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.
FDA confirms approach to Sofdra™ NDA resubmission
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix Pharmaceuticals has announced that the Company has received feedback from FDA following its “end of review” Type A meeting request in respect to the Sofdra™ new drug application review that was completed in September 2023.
FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for the resubmission of the Sofdra NDA package.
Botanix CEO, Dr Howie McKibbon said:
“We are thankful to the Division for confirming the approach and materials proposed to be included in the resubmission of the NDA for Sofdra which we are on track to file in early 1Q CY2024.
“The team will be working over the holiday break to ensure we complete the human factors study and assemble the materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”
