Anavex Life Sciences shares surge 34.94% premarket after FDA provides constructive feedback on Alzheimer’s drug program.

Anavex Life Sciences surged 34.94% in premarket trading following the announcement that the FDA engaged in a constructive Type C meeting to review its Alzheimer’s drug blarcamesine (ANAVEX®2-73). The agency expressed interest in the drug’s clinical data, including its oral administration convenience and absence of amyloid-related imaging abnormalities (ARIA), and outlined pathways for submitting Phase IIb/III trial data to support a New Drug Application (NDA). The company emphasized the FDA’s collaborative approach and commitment to advancing regulatory discussions, which signaled progress in its Alzheimer’s disease program. This positive regulatory feedback, coupled with the FDA’s acknowledgment of the drug’s safety profile and development potential, directly drove the sharp premarket increase.