Ax­some says FDA wants more da­ta for Alzheimer’s ag­i­ta­tion la­bel ex­pan­sion, but read­out to come soon­er 

Ax­some Ther­a­peu­tics said the FDA wants safe­ty in­for­ma­tion from the biotech’s third Phase III study of its drug can­di­date for Alzheimer’s dis­ease ag­i­ta­tion be­fore sub­mit­ting a la­bel ex­pan­sion re­quest.

The reg­u­la­tor wants long-term safe­ty da­ta from pa­tients in that in­di­ca­tion, which the com­pa­ny has pre­vi­ous­ly said af­fects up to 70% of pa­tients with Alzheimer’s. The Phase III com­ple­tion could come about a year soon­er than pre­vi­ous­ly an­tic­i­pat­ed, though, with the time­line for AD­VANCE-2 mov­ing from mid-2025 to the first half of next year, per a quar­ter­ly up­date Mon­day morn­ing.

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