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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.”
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.”
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.
https://botanixpharma.com/wp-content/uploads/Human-factors-validation.png8501600Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2023-12-13 22:44:412023-12-13 22:44:41Successful completion of human factors validation study assessing revised Instructions for Use for Sofdra™
Botanix 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.”
Botanix has today announced it has received firm commitments for $13.5m via an institutional placement, with proceeds to support preparation for commercial launch activities for Sofdra™.
The Company has welcomed support from a significant number of new and existing institutional and sophisticated investors.
Proceeds from the Placement will support preparation for commercial launch activities of Sofdra in the United States, as well as general working capital purposes and costs of the Placement.
Botanix Executive Chairman, Vince Ippolito, said:
“We are extremely pleased to announce this Placement to institutional investors, with the resubmission to FDA pending and approval planned for mid-2024.
“There are a number of initiatives that need to be completed to ensure a successful launch of Sofdra and subsequent revenue growth, and this new capital enables those initiatives to be accelerated.”
Botanix Pharmaceuticals (ASX:BOT) has signed an exclusive agreement with UpScriptHealth® to provide the digital platform and telehealth services for the commercial launch of Sofdra™ (sofpironium bromide) gel, 15%. The agreement with UpScriptHealth is an important step towards building the commercial infrastructure for the successful launch of Sofdra following approval.
UpScriptHealth was the first company to deliver prescriptions online. With more than 1 million patients served, UpScript is the leading digital platform for pharmaceutical companies to offer medications and other therapeutics direct to consumers.
The UpScript website will be the first point of entry for the majority of patients seeking a prescription for Sofdra gel. Patients will be matched with UpScript’s nationwide network of licensed U.S. physicians for online consultations. If a physician finds that a patient is an appropriate candidate, an electronic prescription will be issued and forwarded to a pharmacy that fills it and then ships it to the customer’s home or office.
For patients who are actively seeking support and solutions online, UpScript provides a fast, convenient, clickable option.
Botanix CEO, Dr Howie McKibbon said: “Our exclusive agreement with UpScriptHealth® forms a cornerstone of the commercial infrastructure required for the successful launch of Sofdra™ (sofpironium bromide) gel, 15%. UpScriptHealth’s proven digital platform and telehealth services are expected to greatly facilitate Sofdra prescriptions.
“UpScript will provide a fast, convenient, clickable option for patients seeking hyperhidrosis solutions online. Botanix and our patients will benefit from the enhanced patient access offered by UpScript’s digital hub.”
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.”
Click here to read the ASX release.
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.”
Click here to read the ASX release.
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.
Click here to read the ASX release.
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.”
Click here to read the ASX release.
$13.5M institutional placement
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix has today announced it has received firm commitments for $13.5m via an institutional placement, with proceeds to support preparation for commercial launch activities for Sofdra™.
The Company has welcomed support from a significant number of new and existing institutional and sophisticated investors.
Proceeds from the Placement will support preparation for commercial launch activities of Sofdra in the United States, as well as general working capital purposes and costs of the Placement.
Botanix Executive Chairman, Vince Ippolito, said:
“We are extremely pleased to announce this Placement to institutional investors, with the resubmission to FDA pending and approval planned for mid-2024.
“There are a number of initiatives that need to be completed to ensure a successful launch of Sofdra and subsequent revenue growth, and this new capital enables those initiatives to be accelerated.”
Click here to read today’s ASX release.
Botanix Pharmaceuticals signs exclusive agreement with leading telehealth provider UpScriptHealth®
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix Pharmaceuticals (ASX:BOT) has signed an exclusive agreement with UpScriptHealth® to provide the digital platform and telehealth services for the commercial launch of Sofdra™ (sofpironium bromide) gel, 15%. The agreement with UpScriptHealth is an important step towards building the commercial infrastructure for the successful launch of Sofdra following approval.
UpScriptHealth was the first company to deliver prescriptions online. With more than 1 million patients served, UpScript is the leading digital platform for pharmaceutical companies to offer medications and other therapeutics direct to consumers.
The UpScript website will be the first point of entry for the majority of patients seeking a prescription for Sofdra gel. Patients will be matched with UpScript’s nationwide network of licensed U.S. physicians for online consultations. If a physician finds that a patient is an appropriate candidate, an electronic prescription will be issued and forwarded to a pharmacy that fills it and then ships it to the customer’s home or office.
For patients who are actively seeking support and solutions online, UpScript provides a fast, convenient, clickable option.
Botanix CEO, Dr Howie McKibbon said:
“Our exclusive agreement with UpScriptHealth® forms a cornerstone of the commercial infrastructure required for the successful launch of Sofdra™ (sofpironium bromide) gel, 15%. UpScriptHealth’s proven digital platform and telehealth services are expected to greatly facilitate Sofdra prescriptions.
“UpScript will provide a fast, convenient, clickable option for patients seeking hyperhidrosis solutions online. Botanix and our patients will benefit from the enhanced patient access offered by UpScript’s digital hub.”
Click here to read the ASX release.