Up­dat­ed: Quince eyes PhI­II tri­al start for rare pe­di­atric dis­ease drug-de­vice as FDA lifts clin­i­cal hold

The FDA has lift­ed a tem­po­rary clin­i­cal hold on Ery­Del’s IND for its rare dis­ease drug-de­vice prod­uct, bod­ing well for Cal­i­for­nia biotech Quince Ther­a­peu­tics, which is set to ac­quire Ery­Del.

Quince should now be able to pro­ceed as planned with the place­bo-con­trolled Phase III NEAT tri­al of the drug-de­vice com­bi­na­tion, Ery­Dex, in chil­dren with atax­ia-telang­iec­ta­sia (A-T). The FDA had hit pause on NEAT in Oc­to­ber 2022 to re­quest in­for­ma­tion on the change in plas­tics used in the de­vice por­tion.

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