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 Medicines
Co. (MDCO) (which is being acquired by Novartis (NVS))
moving forward with inclisiran, Alnylam will likely be generating
revenue from four drugs in 2020, with a fifth (Sanofi's (NASDAQ:SNY) fitusiran) not far behind in 2021.
Follow this link for more:
With Positive Phase III Data From Lumasiran, Alnylam On Track For Another Approval
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