Actinogen Medical Ltd. Achieves FDA Agreement for Streamlined Development of Alzheimer's Drug Xanamem
Reuters
Sep 15
<a href="https://laohu8.com/S/ACWNB.AU">Actinogen Medical Ltd</a>. Achieves FDA Agreement for Streamlined Development of Alzheimer's Drug Xanamem
Actinogen Medical Ltd. has announced a significant milestone in its ongoing efforts to gain regulatory approval for Xanamem, a treatment for Alzheimer's disease. Following a Type C meeting with the US Food & Drug Administration (FDA), the company has reached a common understanding with the agency on the pathway to marketing approval. This includes agreement on regulatory starting materials, the design of an additional pivotal clinical trial, and the limited number of ancillary clinical pharmacology trials and nonclinical studies required. The FDA's approval of the planned program allows Actinogen to proceed with confidence, aiming for a future US marketing approval of Xanamem. The ongoing XanaMIA pivotal phase 2/3 trial is on track, with interim analysis expected in January 2026 and final results later that year.
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