About Haley Chartres

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Entries by Haley Chartres

Botanix resubmission of NDA for Sofdra™ completed

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 […]

Successful completion of human factors validation study assessing revised Instructions for Use for Sofdra™

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: […]

$13.5M institutional placement

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 […]

Research note | Continued Strong Sales from Japanese Partner

Euroz Hartleys has published a research note on the performance of Kaken Pharmaceuticals, our Japanese pharmaceutical partner, which may provide insight into rapid growth potential for Sofpironium Bromide in the US. Analyst Seth Lizee wrote: “Sales of Sofpironium Bromide (branded as “Ecclock”) grew 71% pcp to ¥700 million in Q2 2023. Moreover, Kaken upgraded its […]

Botanix Pharmaceuticals signs exclusive agreement with leading telehealth provider UpScriptHealth®

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 […]

FDA conditionally approves Sofdra™ as a trade name for sofpironium bromide

Botanix (ASX: BOT) announced today that the U.S. Food and Drug Administration (FDA) has conditionally approved a trade name for sofpironium bromide gel, 15%.  Pending final approval by the FDA, the once-daily topical gel for the treatment of primary axillary hyperhidrosis will be known as Sofdra™.  Our team developed trade name options which would satisfy […]

Investor Webinar Replay | 26 September 2023

Botanix (ASX: BOT) has received a communication from FDA in relation to its NDA submission for Sofpironium Bromide gel, 15% (SB) for the treatment of primary axillary hyperhidrosis. Encouragingly, no clinical efficacy, safety or manufacturing issues were raised and no additional clinical studies are required by the FDA to support approval. We will be revising […]

Bioshares Summit

Botanix is joining the biotech investment community at the 17th Bioshares Biotech Summit in Hobart this week. This year’s theme is ‘partnering and financing’, and Botanix Executive Director, Matt Callahan, will be sharing insights into the Company’s progress navigating towards FDA approval for Sofpironium Bromide. Click here to review the presentation.