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Actinogen Medical ( (AU:ACW) ) just unveiled an update.
Actinogen Medical has reached a significant milestone by securing agreement with the FDA on the necessary steps for US marketing approval of Xanamem for Alzheimer’s disease. This includes the design of a pivotal Phase 3 trial and other clinical and nonclinical activities. The FDA’s guidance enables Actinogen to move forward confidently with its development plans and enhances its positioning for discussions with potential partners. This development aligns with global regulatory efforts to find more effective therapies for Alzheimer’s, potentially impacting stakeholders positively by advancing treatment options.
More about Actinogen Medical
Actinogen Medical is an ASX-listed biotechnology company focused on developing novel therapies for neurological and neuropsychiatric diseases linked to dysregulated brain cortisol. Their lead compound, Xanamem, is being developed as a treatment for Alzheimer’s Disease and Depression, with potential future applications in Fragile X Syndrome and other conditions. The company aims to address the substantial unmet medical need for improved treatments in these areas.
YTD Price Performance: 8.00%
Average Trading Volume: 2,922,406
Technical Sentiment Signal: Sell
Current Market Cap: A$85.74M
See more data about ACW stock on TipRanks’ Stock Analysis page.