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Botanix Pharmaceuticals (BOT) has completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration’s (FDA) Office of Infectious Diseases.
The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections (SSIs) in the U.S.
It also enabled the company to receive feedback from the FDA on the drug development plan needed for BTX 1801 to support a Fast Track designation and New Drug Application (NDA).
Click through to read the full article on The Market Herald here.
https://botanixpharma.com/wp-content/uploads/AdobeStock_242863559-scaled.jpeg17072560Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2020-11-12 01:58:132023-03-13 21:16:45Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development
The Green Fund has published a summary of Botanix Pharmaceutical’s BTX 1801 announcement today, an update on the development pathway for our BTX 1801 antimicrobial product.
https://botanixpharma.com/wp-content/uploads/Screen-Shot-2020-11-12-at-12.40.46-pm.png9701462Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2020-11-12 01:42:262023-03-13 21:16:45Botanix Pharma Talks With FDA on Antibacterial Drug
Botanix (ASX:BOT) has today announced it has secured a clear development path from the FDA for its BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting.
Our team will have more clinical data to share soon too – our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.
Botanix Pharmaceuticals has released its latest Quarterly Report – a period which has delivered a series of progress milestones.
In our antimicrobial program, we commenced a Phase 2a clinical trial for BTX 1801 to study the use of synthetic cannabidiol in the prevention of surgical site infections. We also shared new data from an ex vivo efficacy study, which further validates the mechanism of action of our antimicrobial platform.
In our dermatology program, we successfully completed an End of phase 2 meeting with the FDA for our BTX 1503 acne product. We’re also looking forward to commencing recruitment for our BTX 1702 program for the treatment of Rosacea, when COVID-19 travel restrictions ease.
Botanix has appeared in a must-read feature about antimicrobial resistance (AMR) in the latest edition of AusBiotech’s Australasian Biotechnology Journal.
It is titled, “Antimicrobial resistance: a global health emergency”.
A quote from WHO Director-General Dr Tedros Adhanom Ghebreyesus, featured in the story, points to the importance of the work we are doing in this space:
“AMR is a slow tsunami that threatens to undo a century of medical progress. A record number of countries are now monitoring and reporting on antibiotic resistance to WHO”.
https://botanixpharma.com/wp-content/uploads/WEBSITE.png9001600administrator/wp-content/uploads/botanix-logo.pngadministrator2020-10-12 21:28:002023-03-13 21:17:07Antimicrobial resistance: a global health emergency
The Motley Fool’s Aaron Teboneras featured Botanix Pharmaceuticals as a top stock pick in an article today.
“At the time of writing, the Botanix share price is trading at 10 cents, up 7.5% for the day. With a market capitalisation of $97 million, if the company can perform to market expectations, its share price will soar.”
https://botanixpharma.com/wp-content/uploads/hydrix-share-price.jpg9931765Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2020-10-05 21:00:562023-03-13 21:17:07Why I think these small cap ASX shares will perform in 2021
Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development
/in Featured, Latest News, News /by Haley ChartresBotanix Pharmaceuticals (BOT) has completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration’s (FDA) Office of Infectious Diseases.
The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections (SSIs) in the U.S.
It also enabled the company to receive feedback from the FDA on the drug development plan needed for BTX 1801 to support a Fast Track designation and New Drug Application (NDA).
Click through to read the full article on The Market Herald here.
Botanix Pharma Talks With FDA on Antibacterial Drug
/in Featured, Latest News, News /by Haley ChartresThe Green Fund has published a summary of Botanix Pharmaceutical’s BTX 1801 announcement today, an update on the development pathway for our BTX 1801 antimicrobial product.
Take a look at the article here.
BTX 1801 Update
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) has today announced it has secured a clear development path from the FDA for its BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting.
Our team will have more clinical data to share soon too – our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.
Read today’s ASX release here.
Quarterly Report
/in Featured, Latest News, News /by administratorBotanix Pharmaceuticals has released its latest Quarterly Report – a period which has delivered a series of progress milestones.
In our antimicrobial program, we commenced a Phase 2a clinical trial for BTX 1801 to study the use of synthetic cannabidiol in the prevention of surgical site infections. We also shared new data from an ex vivo efficacy study, which further validates the mechanism of action of our antimicrobial platform.
In our dermatology program, we successfully completed an End of phase 2 meeting with the FDA for our BTX 1503 acne product. We’re also looking forward to commencing recruitment for our BTX 1702 program for the treatment of Rosacea, when COVID-19 travel restrictions ease.
Read the full report here.
Antimicrobial resistance: a global health emergency
/in Featured, Journal Articles, Latest News, News /by administratorBotanix has appeared in a must-read feature about antimicrobial resistance (AMR) in the latest edition of AusBiotech’s Australasian Biotechnology Journal.
It is titled, “Antimicrobial resistance: a global health emergency”.
A quote from WHO Director-General Dr Tedros Adhanom Ghebreyesus, featured in the story, points to the importance of the work we are doing in this space:
“AMR is a slow tsunami that threatens to undo a century of medical progress. A record number of countries are now monitoring and reporting on antibiotic resistance to WHO”.
Read the full story on pages 52-54 here.
Why I think these small cap ASX shares will perform in 2021
/in Featured, Latest News, News /by Haley ChartresThe Motley Fool’s Aaron Teboneras featured Botanix Pharmaceuticals as a top stock pick in an article today.
“At the time of writing, the Botanix share price is trading at 10 cents, up 7.5% for the day. With a market capitalisation of $97 million, if the company can perform to market expectations, its share price will soar.”
Read the full article here.