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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.”
Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2022.
Key highlights from this period include:
FDA accepted NDA filing for Sofpironium Bromide as sufficiently complete for a substantive review
FDA confirmed that a mid-cycle review of the NDA is planned for 1Q 2023
Independent market research project completed by Triangle Insights confirms significant revenue opportunity for Sofpironium Bromide and positive feedback from key physician, payer (insurance) and patient stakeholders, who were surveyed on a blinded basis
Successfully raised $5.96M via a placement to institutional shareholder Antares Capital and Shareholder Purchase Plan to existing holders
Successful Phase 1b/2 clinical study for BTX 1702 in rosacea completed
Cash position of $8.72 million at quarter end, with pivotal Sofpironium Bromide mid-cycle review meeting due this quarter
Botanix will be attending the JP Morgan Healthcare Conference in San Francisco this week. The conference attracts more than 50,000 attendees from around the world, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
As part of the conference, Botanix will be discussing the significant commercial potential of Sofpironium Bromide and sharing some of the independent market research recently completed by Triangle Insights.
With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, we are pleased to report that the mid-cycle review remains on track for this quarter.
Botanix is pleased to share an analyst report published by Euroz Hartleys following this week’s announcement that our Company has received formal written communication from the FDA, confirming that our New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.
Analyst Seth Lizee classified the Company as a ‘Speculative Buy, $0.27 Price Target’, and commented on this achievement:
“Overall, we view this is as yet another milestone met, bringing BOT one step closer to potential FDA approval, and in time commercialisation.”
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
Quarterly Activities Report and 4C Quarterly Cash Flow Report
/in ASX Releases, Featured, Latest News, News /by Haley ChartresBotanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2022.
Key highlights from this period include:
Click here to read today’s ASX release
JP Morgan Healthcare Conference Presentation
/in ASX Releases, Featured, Latest News /by Haley ChartresBotanix will be attending the JP Morgan Healthcare Conference in San Francisco this week. The conference attracts more than 50,000 attendees from around the world, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
As part of the conference, Botanix will be discussing the significant commercial potential of Sofpironium Bromide and sharing some of the independent market research recently completed by Triangle Insights.
With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, we are pleased to report that the mid-cycle review remains on track for this quarter.
Click here to view the presentation.
Research Report by Euroz Hartleys – 8 December 2022
/in Featured, Latest News, News /by Haley ChartresBotanix is pleased to share an analyst report published by Euroz Hartleys following this week’s announcement that our Company has received formal written communication from the FDA, confirming that our New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.
Analyst Seth Lizee classified the Company as a ‘Speculative Buy, $0.27 Price Target’, and commented on this achievement:
“Overall, we view this is as yet another milestone met, bringing BOT one step closer to potential FDA approval, and in time commercialisation.”
Read the full report.