Some investors may well believe that Alnylam (ALNY) had already de-risked its lumasiran program for primary hyperoxaluria Type 1 (or PH1) with strong Phase II and open-label extension study data, but there is a reason that the FDA requires pivotal studies, and Alnylam came through with strong clinical results that will support a New Drug Application to the FDA early in 2020 and likely an approval before the end of the year.
With the positive lumasiran results, Alnylam is closing in on its third wholly-owned commercial product (joining Onpattro and Givlaari), and The