Al­ny­lam shares dip on a de­ci­sion to scrap ac­cel­er­at­ed pitch on givosir­an; Loxo gets a 'break­through' at the FDA

→ Al­ny­lam $AL­NY has de­cid­ed to put a hold on its plans to shoot for an ac­cel­er­at­ed ap­proval of givosir­an and in­stead start a rolling sub­mis­sion in search of a full ap­proval. In­vestors didn’t care for what looked like a slow­down, dri­ving shares down by 1.8%. But at least one an­a­lyst was hold­ing fire this morn­ing. Stifel’s Paul Mat­teis not­ed: “This is not a sur­prise to us: this plan is, in our opin­ion, a byprod­uct of faster than ex­pect­ed en­roll­ment of the phase III EN­VI­SION tri­al, and we’d be buy­ing the stock on any weak­ness that en­sues.” This drug has been lined up as Al­ny­lam’s sec­ond RNAi drug in­tend­ed for the mar­ket. The drug is de­signed to treat acute he­pat­ic por­phyr­ia.

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