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Botanix has today released an update regarding the progress of its lead product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis – a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.
The U.S. Food and Drug Administration (FDA) has now conducted the mid-cycle review meeting for Sofpironium Bromide, and no significant issues have been identified, as a result of the review. This includes no major clinical safety issues, no risk management issues, or advisory board requirements.
The Company has also announced a capital raise to support the next stage of our New Drug Application (NDA) filing.
Botanix (ASX: BOT) hosted a webinar to update shareholders on the Company’s preparations for the FDA mid-cycle review of Sofpironium Bromide in Q1 2023.
The webinar was hosted by Gautam Aggarwal, a Partner with Triangle Insights Group, who has conducted insightful market research in relation to the Sofpironium Bromide.
Other presenters included Botanix Executive Director, Matt Callahan and Botanix Chief Operating Officer, Dr Howie McKibbon.
https://botanixpharma.com/wp-content/uploads/BOT-website-webinar.png8501600Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2023-03-09 22:06:172023-03-13 21:15:26Investor Webinar | March 2023
Botanix has today appeared in Stockhead in an article titled, ‘As it awaits crucial FDA approval Botanix reckons Aussies have a penchant for backing high-risk companies.’
This special report explores the appetite for Australian investors to back companies with a high risk to reward ratio, and why Botanix stands out as a stock to watch as we move towards the mid cycle review milestone with the Food and Drug Administration (FDA) for our lead product, Sofpironium Bromide.
Botanix COO, Dr Howie McKibbon, has extensive experience at this stage of the biotech race and is quoted in the article:
“The drug has already been launched by our partner in Japan in 2020 and the reaction there has been great, so we are now very busy implementing a full-scale commercialisation
strategy, pending a final FDA approval in Q3 this year.’’
Botanix’s co-founder and Executive Director, Matt Callahan, was featured in a story in The West Australian newspaper by business reporter Cheyanne Encisco.
The article highlighted the FDA’s upcoming mid-cycle review of Botanix’s application for its lead product, Sofpironium Bromide gel, for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating.
In the article, Mr Callahan spoke confidently of the imminent mid-cycle review, and that a positive outcome would substantially de-risk the probability of approval.
“We’re very confident going into this review, given all the work that we’ve done, that we’ve ticked all the boxes,” Mr Callahan said.
https://botanixpharma.com/wp-content/uploads/BOT-website-newspaper.png8501600Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2023-02-14 21:34:002023-03-13 21:15:26Botanix co-founder says interest for sweat-stopper gel is keeping him bullish ahead of FDA review | The West Australian
A recent analyst report by Euroz Hartleys predicting significant upside for Botanix if the Company’s Sofpironium Bromide New Drug Application (NDA) is successful, has been featured on Stockhead.
Journalist Eddy Sunarto highlighted the analyst’s prediction that the share price could triple if FDA approval for the treatment of primary axillary hyperhidrosis is achieved in Q3 of this year.
https://botanixpharma.com/wp-content/uploads/BOT_website-analyst-report-1.png8501600Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2023-02-14 08:50:002023-03-13 21:15:26This broker says Botanix Pharma’s share price could more than triple on an FDA approval | Stockhead
Euroz Hartleys has published an analyst note, reporting that the mid-cycle review for Botanix’s FDA New Drug Application (NDA) for Sofpironium Bromide remains on track for this quarter (Q1 CY23).
Analyst Seth Lizée noted the experience of the Botanix team in securing FDA-approval, and successfully commercialising over 30 products. He classified Botanix as a ‘Speculative Buy, Target Price $0.27’, commenting:
“We believe Sofpironium Bromide could potentially do A$130m of sales in the USA within its first year based on the number of prescriptions the drug is currently doing through its partner in Japan, a country which has a population nearly a third the size of the USA.”
Mid-Cycle Review Complete + Capital Raise
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix has today released an update regarding the progress of its lead product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis – a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.
The U.S. Food and Drug Administration (FDA) has now conducted the mid-cycle review meeting for Sofpironium Bromide, and no significant issues have been identified, as a result of the review. This includes no major clinical safety issues, no risk management issues, or advisory board requirements.
The Company has also announced a capital raise to support the next stage of our New Drug Application (NDA) filing.
Click here to read ASX release.
Investor Webinar | March 2023
/in Featured, Latest News, News, Presentations, Videos /by Haley ChartresBotanix (ASX: BOT) hosted a webinar to update shareholders on the Company’s preparations for the FDA mid-cycle review of Sofpironium Bromide in Q1 2023.
The webinar was hosted by Gautam Aggarwal, a Partner with Triangle Insights Group, who has conducted insightful market research in relation to the Sofpironium Bromide.
Other presenters included Botanix Executive Director, Matt Callahan and Botanix Chief Operating Officer, Dr Howie McKibbon.
Special Report | Stockhead
/in Featured, Latest News, News /by Haley ChartresBotanix has today appeared in Stockhead in an article titled, ‘As it awaits crucial FDA approval Botanix reckons Aussies have a penchant for backing high-risk companies.’
This special report explores the appetite for Australian investors to back companies with a high risk to reward ratio, and why Botanix stands out as a stock to watch as we move towards the mid cycle review milestone with the Food and Drug Administration (FDA) for our lead product, Sofpironium Bromide.
Botanix COO, Dr Howie McKibbon, has extensive experience at this stage of the biotech race and is quoted in the article:
“The drug has already been launched by our partner in Japan in 2020 and the reaction there has been great, so we are now very busy implementing a full-scale commercialisation
strategy, pending a final FDA approval in Q3 this year.’’
Click here to read the article.
Botanix co-founder says interest for sweat-stopper gel is keeping him bullish ahead of FDA review | The West Australian
/in Featured, Latest News, News /by Haley ChartresBotanix’s co-founder and Executive Director, Matt Callahan, was featured in a story in The West Australian newspaper by business reporter Cheyanne Encisco.
The article highlighted the FDA’s upcoming mid-cycle review of Botanix’s application for its lead product, Sofpironium Bromide gel, for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating.
In the article, Mr Callahan spoke confidently of the imminent mid-cycle review, and that a positive outcome would substantially de-risk the probability of approval.
“We’re very confident going into this review, given all the work that we’ve done, that we’ve ticked all the boxes,” Mr Callahan said.
Read the article
This broker says Botanix Pharma’s share price could more than triple on an FDA approval | Stockhead
/in Featured, Latest News, News /by Haley ChartresA recent analyst report by Euroz Hartleys predicting significant upside for Botanix if the Company’s Sofpironium Bromide New Drug Application (NDA) is successful, has been featured on Stockhead.
Journalist Eddy Sunarto highlighted the analyst’s prediction that the share price could triple if FDA approval for the treatment of primary axillary hyperhidrosis is achieved in Q3 of this year.
Read the full article.
Analyst Report by Euroz Hartleys – 01 February 2023
/in Featured, Latest News, News /by Haley ChartresEuroz Hartleys has published an analyst note, reporting that the mid-cycle review for Botanix’s FDA New Drug Application (NDA) for Sofpironium Bromide remains on track for this quarter (Q1 CY23).
Analyst Seth Lizée noted the experience of the Botanix team in securing FDA-approval, and successfully commercialising over 30 products. He classified Botanix as a ‘Speculative Buy, Target Price $0.27’, commenting:
“We believe Sofpironium Bromide could potentially do A$130m of sales in the USA within its first year based on the number of prescriptions the drug is currently doing through its partner in Japan, a country which has a population nearly a third the size of the USA.”
Read the full report