Net Loss: ($163.6M) (-38.2%); Non-GAAP Net Loss: ($161.9M) (-71.5%); Loss Per Share: ($1.63) (-21.6%); Non-GAAP Loss Per Share: ($1.61) (-50.5%).
The Company is on track to start the Phase 3 study in late 2018 and plans to start additional Phase 3 studies of ALN-TTRsc02, including in wild-type ATTR amyloidosis, in 2019.
Upcoming Events: In mid-2018, Alnylam intends to:Achieve FDA approval and launch ONPATTRO in the U.S.
Gain regulatory approval for ONPATTRO from the EC, File a Japanese NDA for ONPATTRO with the Pharmaceuticals and Medical Device Agency.
Initiate the lumasiran Phase 3 study.
In late 2018, Alnylam intends to: File for regulatory approval for ONPATTRO in additional global markets.
File an NDA for givosiran with the FDA for accelerated approval, assuming positive results and acceptable safety from the interim analysis of the ENVISION Phase 3 study and pending FDA review.
Present updated data from the Phase 1/2 and OLE studies of lumasiran, at the ESPN Annual Meeting in Antalya, Turkey and at the ASN Kidney Week Meeting in San Diego, CA., respectively, in October.
Initiate the Phase 3 study for ALN-TTRsc02 in hATTR amyloidosis.
File new Investigational New Drug, including ALN-AAT02 and ALN-HBV02 (also known as VIR-2218).
Complete selection of its first CNS-targeted development candidate.
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