Claim­ing a win where Gilead failed, Sier­ra touts PhI­II suc­cess in a JAK in­hibitor — and is ready to take it to the FDA

About three and a half years ago, Sier­ra On­col­o­gy took on a for­mer­ly failed JAK in­hibitor can­di­date from Gilead, be­liev­ing it could suc­ceed where the big­ger bio­phar­ma failed. On Tues­day, the biotech re­vealed the pro­gram passed a Phase III test.

Sier­ra un­veiled pos­i­tive topline da­ta for mo­melo­tinib, say­ing the ex­per­i­men­tal drug met its pri­ma­ry end­point and both sec­on­daries in myelofi­bro­sis pa­tients who are symp­to­matic, ane­mic and were pre­vi­ous­ly treat­ed with an FDA-ap­proved JAK in­hibitor. With the new da­ta in hand, Sier­ra now plans to sub­mit an NDA some­time in the sec­ond quar­ter.

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