Alnylam (ALNY) announced that Sanofi Genzyme declined its opt-in for the development and commercialization of the RNAi product lumasiran, an investigational RNAi therapeutic for the treatment of Primary Hyperoxaluria Type 1 (PH1). Based on this decision, Alnylam intends to rapidly advance lumasiran into a Phase 3 pivotal study in late 2018, and to commercialize lumasiran globally, assuming product approval.

Alnylam has also announced that the FDA has granted lumasiran Breakthrough Therapy Designation (BTD), which is the third the firm has received to date for programs in its pipeline.

Yvonne Greenstreet, MBChB, MBA, Chief . . .