Three years lat­er the FDA fi­nal­ly lifts its hold on Ap­tose drug, set­ting the stage for a re­turn to PhIb

Af­ter an al­most three-year halt im­posed by a clin­i­cal hold, Ap­tose Bio­sciences can fi­nal­ly re­sume the Phase Ib tri­al for its MYC in­hibitor.

The San Diego-based biotech $AP­TO ex­plained to­day that the clin­i­cal hold on the tri­al of AP­TO-253 was a con­se­quence of an event re­lat­ed to the in­fu­sion pro­ce­dure, which — a root cause in­ves­ti­ga­tion de­ter­mined — re­sult­ed from “chem­istry and man­u­fac­tur­ing based is­sues.” All of them have now been in­cor­po­rat­ed in an amend­ment to the IND ap­pli­ca­tion.

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