Crown jew­el in big Gilead buy­out lands break­through des­ig­na­tion for MDS

Months af­ter Gilead snagged ma­grolimab in the $4.9 bil­lion buy­out of Cal­i­for­nia biotech Forty Sev­en — the com­pa­ny’s largest ac­qui­si­tion in three years at the time — the an­ti-CD47 mon­o­clon­al an­ti­body is now on an ex­pe­dit­ed track to ap­proval.

On Tues­day morn­ing, Gilead an­nounced ma­grolimab’s FDA break­through ther­a­py des­ig­na­tion for pa­tients with new­ly-di­ag­nosed myelodys­plas­tic syn­drome (MDS). No new MDS treat­ments have been ap­proved in 14 years, ac­cord­ing to the com­pa­ny.

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