Ad­verum Bio of­fers a late no­ti­fi­ca­tion about FDA hold on lead gene ther­a­py for wet AMD

The FDA has some ques­tions for Ad­verum Biotech­nolo­gies about the CMC work re­lat­ed to their lead gene ther­a­py for wet, age-re­lat­ed mac­u­lar de­gen­er­a­tion, and reg­u­la­tors have put a clin­i­cal hold on their clin­i­cal de­vel­op­ment pro­gram un­til they get some an­swers.

The Men­lo Park, CA-based biotech $AD­VM re­port­ed Mon­day as the mar­ket opened that the agency had placed a hold on their drug “in ear­ly April” and were now re­view­ing a re­sponse to their query, sub­mit­ted last week. This was the first chance that in­vestors got to hear about this news from the pub­lic com­pa­ny, which re­served word about the FDA ac­tion un­til af­ter they not­ed they had a green light from the in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee for the re­cruit­ment of their sec­ond co­hort of pa­tients for AD­VM-022 — which they say was the chrono­log­i­cal or­der of events.

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