Alnylam shares drop 1.8% on new FDA approval strategy for rare disease drug
Alnylam Pharmaceuticals Inc. shares dropped 1.8% in Monday premarket trade after the company announced that it intends to apply for full U.S. approval of its rare disease drug, rather than a faster-than-usual approval, signifying a more extended approval timeline for the therapy. The drug, givosiran, is currently in a phase 3 clinical trial, with preliminary results expected in early 2019. Alnylam plans to submit a “rolling” new drug application with the Food and Drug Administration starting this year, with full clinical trial results from the phase 3 trial to be submitted in mid-2019. Givosiran is intended for acute hepatic porphyria, a group of rare genetic diseases characterized by attacks that can be life-threatening, as well as chronic and painful symptoms. Alnylam’s decision to go for full approval is “not a surprise to us: this plan is, in our opinion, a byproduct of faster than expected enrollment of the phase III Envision trial, and we’d be buying the stock on any weakness that ensues,” said Stifel analyst Paul Matteis, who noted that company management had previously suggested that this might happen. Alnylam shares have dropped 23.8% over the last three months, compared with a 1.2% decline in the S&P 500 and a 1.3% rise in the Dow Jones Industrial Average .