FDA lifts a clin­i­cal hold on Se­lec­ta gene ther­a­py af­ter an­oth­er de­lay ham­pers R&D plans

Three months af­ter Se­lec­ta Bio­Sciences got word that the FDA had slapped a clin­i­cal hold on its Phase I/II study of methyl­malonic acidemia drug SEL-302 to clear up some CMC is­sues, the biotech says they are back in busi­ness.

“I am pleased to an­nounce that on March 9th the FDA lift­ed the clin­i­cal hold on our SEL-302 gene ther­a­py pro­gram to treat methyl­malonic acidemia. We look for­ward to start­ing our phase 1 clin­i­cal tri­al ex­pe­di­tious­ly and to bring hope to those pa­tients and fam­i­lies seek­ing a po­ten­tial­ly durable and life­long treat­ment for this ter­ri­ble dis­ease,” said Se­lec­ta CEO Carsten Brunn in a pre­pared state­ment.

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