Gilead­'s $1.7B hep D drug just ran in­to a road­block at the FDA

Gilead was fol­low­ing Ger­man biotech Myr and its he­pati­tis delta virus can­di­date for “quite some time” be­fore fi­nal­ly pulling the trig­ger on a $1.7 bil­lion buy­out deal. With an EU au­tho­riza­tion al­ready un­der its belt, an OK in the US was all but a done deal — or so it thought.

The com­pa­ny re­port­ed an FDA re­jec­tion dur­ing its Q3 earn­ings call on Thurs­day, leav­ing CMO Mer­dad Parsey “dis­ap­point­ed” and spoil­ing the $360 mil­lion mile­stone that Myr would have reaped on an FDA ap­proval. So what hap­pened?

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