- Alnylam Pharmaceuticals Inc ALNY shares are rallying after upbeat data from APOLLO-B Phase 3 study of patisiran for transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
- Clumps of irregular proteins called fibrils build up in the heart harder for the heart to pump blood.
- The trial met the primary endpoint of change from baseline in the 6-Minute Walk Test (6-MWT) at 12 months compared to placebo.
- The study also met the first secondary endpoint of change from baseline in quality of life compared to placebo.
- Patisiran also demonstrated an encouraging safety and tolerability profile, with deaths numerically favoring the patisiran arm.
- The company plans to file a supplemental marketing application with the FDA in late 2022.
- Five patients (2.8%) on patisiran and 8 (4.5%) on placebo died. Furthermore, the number of deaths in the all-cause mortality efficacy analysis was 4 (2.2%) in the patisiran arm and 10 (5.6%) in the placebo arm.
- The patisiran and placebo arms had similar frequencies of adverse events.
- Patisiran is marketed as Onpattro, approved in the United States and Canada for polyneuropathy of hATTR amyloidosis in adults.
- Price Action: ALNY shares are up 55.8% at $220.00 during the premarket session on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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