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Botanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the acquisition of our dermatology asset Sofpironium Bromide.
Botanix has today announced acquisition of a novel dermatology asset known as Sofpironium Bromide, which has been developed to treat primary axillary hyperhidrosis – a medical condition which results in excessive underarm sweating.
Sofpironium Bromide is the first and only new chemical entity developed for primary axillary hyperhidrosis, and this product is primed for market following successful pivotal studies conducted in late 2021.
This is a defining deal for Botanix, cementing our credentials as a global leader in the development and commercialisation of novel dermatology products. Sofpironium Bromide complements our existing dermatology pipeline and will leverage the core skills of our newly-expanded management team, with an enviable track record of successfully launching products.
Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company’s March quarterly report.
Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 March 2022
Key highlights from this period include:
Strategic appointments to Botanix’s executive leadership team,including Dr Patty Walker as Chief Medical Officer and Mr Howie McKibbon as Chief Commercial Officer
Danny Sharp also joins as Non-Executive Director bringing 30+ years capital markets experience and an extensive network of institutional investors
Completion of pre-clinical work to support initiation of Phase 2 BTX 1801 antimicrobial study
Advancement of clinical programs, with the completion of recruitment for both the Phase 2 BTX 1702 rosacea study and BTX 1204 canine atopic dermatitis study, both of which are on track for 2Q 2022
Significant progress on broadening and maturing the Botanix pipeline with a number of new opportunities in late-stage assessment
Botanix maintains a strong cash position, with approximately $16.4 million in cash at closing of Q1 2022.
Botanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the Company’s announcement that the US FDA has granted BOT Qualified Infectious Disease Product (QIPD) designation for BTX1801.
Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801.
This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central venous catheters for hemodialysis’, the lead indication for our novel intranasal gel. This represents the first such designation ever granted for a nasal decolonisation agent in this patient group.
In addition to the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA), QIDP offers an additional five years of regulatory exclusivity, as well as eligibility for NDA ‘priority review’ and ‘fast-track designation’ – both of which will be invaluable to Botanix’s antimicrobial development program.
Botanix President and Executive Chairman, Vince Ippolito commented:
“Botanix is very excited to receive QIDP status from the FDA. This designation is supported by our Phase 2 clinical study results and a recent health outcomes study that highlighted the impact of bloodstream infections in hemodialysis patients that use central venous catheters for access.
“These life-threatening infections in this vulnerable population are estimated to cost the health system more than $360 million annually in the US.”
https://botanixpharma.com/wp-content/uploads/BOT-QDIP-Website-TIle-1.png321845Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2022-04-28 00:29:002023-03-13 21:16:03FDA grants new QIDP Designation Status for BTX 1801
Euroz Hartleys Report | 4 May
/in Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the acquisition of our dermatology asset Sofpironium Bromide.
Click here to view the report.
New dermatology asset acquisition
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix has today announced acquisition of a novel dermatology asset known as Sofpironium Bromide, which has been developed to treat primary axillary hyperhidrosis – a medical condition which results in excessive underarm sweating.
Sofpironium Bromide is the first and only new chemical entity developed for primary axillary hyperhidrosis, and this product is primed for market following successful pivotal studies conducted in late 2021.
This is a defining deal for Botanix, cementing our credentials as a global leader in the development and commercialisation of novel dermatology products. Sofpironium Bromide complements our existing dermatology pipeline and will leverage the core skills of our newly-expanded management team, with an enviable track record of successfully launching products.
Click here to view ASX release and presentation.
Euros Hartley Report | 29 April 2022
/in Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company’s March quarterly report.
Click here to view the report.
Quarterly Activities Report and 4C Quarterly Cash Flow Report
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 March 2022
Key highlights from this period include:
Botanix maintains a strong cash position, with approximately $16.4 million in cash at closing of Q1 2022.
Read today’s ASX release here.
Eurox Hartleys Report | 28 April 2022
/in Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the Company’s announcement that the US FDA has granted BOT Qualified Infectious Disease Product (QIPD) designation for BTX1801.
Click here to view the report.
FDA grants new QIDP Designation Status for BTX 1801
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801.
This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central venous catheters for hemodialysis’, the lead indication for our novel intranasal gel. This represents the first such designation ever granted for a nasal decolonisation agent in this patient group.
In addition to the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA), QIDP offers an additional five years of regulatory exclusivity, as well as eligibility for NDA ‘priority review’ and ‘fast-track designation’ – both of which will be invaluable to Botanix’s antimicrobial development program.
Botanix President and Executive Chairman, Vince Ippolito commented:
“Botanix is very excited to receive QIDP status from the FDA. This designation is supported by our Phase 2 clinical study results and a recent health outcomes study that highlighted the impact of bloodstream infections in hemodialysis patients that use central venous catheters for access.
“These life-threatening infections in this vulnerable population are estimated to cost the health system more than $360 million annually in the US.”
Click here to read today’s ASX Release