As FDA lifts clin­i­cal hold on its $4.9B CD47 drug, Gilead talks 2023 read­out, 'un­wa­ver­ing' con­fi­dence

Gilead can breathe a sigh of re­lief as the FDA lifts a par­tial hold on the “break­through” CD47 drug ma­grolimab — al­though the com­pa­ny is not quite off the hook yet.

Af­ter re­view­ing “com­pre­hen­sive safe­ty da­ta,” reg­u­la­tors have re­moved the par­tial clin­i­cal hold on stud­ies test­ing ma­grolimab in com­bi­na­tion with azac­i­ti­dine (Vi­daza), in­clud­ing for myelodys­plas­tic syn­drome (MDS) and acute myeloid leukemia (AML).

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