US RNAi therapeutics company Alnylam Pharmaceuticals (Nasdaq: ALNY) says that Sanofi Genzyme, the biotech unit of French pharma major Sanofi (Euronext: SAN) has declined its opt-in for the development and commercialization of lumasiran (ALN-GO1), 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 III pivotal study in late 2018, and to commercialize lumasiran globally, assuming product approval. In addition, the company also announced that lumasiran has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration, representing the third BTD the company has received to date for programs in its pipeline.
The news did not disturb investors, as Alnylam’s shares moved higher, rising 5.4% to $149.59 by mid-morning.
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