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Biotech Stocks Facing FDA Decision In August

Alnylam Pharmaceuticals
Alnylam Pharmaceuticals

The New Drug Application for Patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis is under priority review by the FDA, with a decision expected on August 11, 2018.

Patisiran is developed by Alnylam Pharmaceuticals (ALNY), using Arbutus Biopharma’s Lipid Nanoparticle (LNP) delivery technology. Successful approval of Patisiran will trigger a royalty entitlement to Arbutus from Alnylam.

Credit Suisse analyst Alethia Young expects Patisiran sales to peak by 2023 at $1.5 billion.

Tegsedi, a drug developed by Akcea and Ionis Pharmaceuticals, for the similar indication, hereditary transthyretin amyloidosis, is under FDA review with a decision expected on October 6, 2018. Tegsedi was approved in the European Union as recently as July 11, 2018.

ALNY closed Wednesday’s (Jul 25) trading at $105.74, up 3.00%.