Alnylam About A Week Away From Its First Approval

With an FDA PDUFA date about one week away for its lead drug patisiran (which Alnylam (ALNY) will market as “Onpattro”), the value in the company’s second quarter earnings report was mostly in regard to its pipeline updates. Alynylam has ample cash to continue moving its deep clinical pipeline toward commercialization, and Alnylam could well be looking at meaningful new drug approvals in 2018 (patisiran), 2019 (givosiran), 2020 (lumasiran, fitusiran, and inclisiran), and 2021 (ALN-TTRsc02), with total peak-revenue potential in the multiple billions of dollars.

Alnylam shares have been weak of late, and there is some modest risk going into the PDUFA date – less so in terms of whether the drug will be approved, but rather what the label will look like. There will also be a more detailed presentation of data from Pfizer’s (PFE) tafamadis later this month, a drug that has more recently re-emerged as a potential competitive threat. All told, though, I believe Alynylam shares remain substantially undervalued today.

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Alnylam About A Week Away From Its First Approval