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Botanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO, Dr Howie McKibbon, is presenting at the Euroz Hartleys Healthcare Forum being held today in Perth, Western Australia. The Conference brings together some of Australia’s leading listed and private healthcare companies, as well as institutional investors from around Australia and the region. Botanix will be outlining the significant […]
Botanix Pharmaceuticals has today announced the Company’s resubmission of the new drug application (NDA) for Sofdra™ has been accepted as a complete response by FDA. FDA also confirmed that the resubmission of the Sofdra NDA is a Class 2 response (i.e., a 6-month review period from the resubmission in late December 2023), with the result […]
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 […]
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: […]
Botanix Pharmaceuticals has announced that the Company has received feedback from FDA following its “end of review” Type A meeting request in respect to the Sofdra™ new drug application review that was completed in September 2023. FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for the resubmission of the […]
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 […]
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 (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 […]
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 […]
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 […]
