Welcome to our dedicated page for Alnylam Pharmaceuticals news (Ticker: ALNY), a resource for investors and traders seeking the latest updates and insights on Alnylam Pharmaceuticals stock.
Alnylam Pharmaceuticals develops and commercializes RNA interference (RNAi) therapeutics, with news centered on its approved medicines, TTR franchise, clinical pipeline and financial performance. Company updates commonly address AMVUTTRA/vutrisiran and ONPATTRO/patisiran for transthyretin-mediated amyloidosis, GIVLAARI/givosiran for acute hepatic porphyria, OXLUMO/lumasiran for primary hyperoxaluria type 1, and partner-commercialized RNAi medicines.
Recurring developments include quarterly product revenue reports, guidance, clinical and real-world data for ATTR-CM and other cardiovascular programs, pipeline progress across cardio-metabolic disease, neuroscience and hematology, disease-awareness collaborations, and investor conference presentations. Alnylam also reports on its Alnylam 2030 strategy and commercialization of RNAi medicines in global markets.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced positive 6-month results from the ILLUMINATE-B Phase 3 study of lumasiran, an RNAi therapeutic for primary hyperoxaluria type 1 (PH1). The study showed a 72% mean reduction in urinary oxalate levels among children under six. Lumasiran's safety profile was assessed as acceptable, with no severe adverse events reported. Lumasiran is also under FDA review, with a decision expected by December 3, 2020. If approved, it will be marketed as OXLUMO in the EU, following a Positive Opinion from the EMA's CHMP.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced a positive opinion from the European Medicines Agency's CHMP for lumasiran, an RNAi therapeutic targeting the HAO1 mRNA for treating primary hyperoxaluria type 1 (PH1). PH1 is a rare disease affecting 3.5 to 4 individuals per million, characterized by excessive oxalate production leading to severe kidney damage. If approved by the European Commission, lumasiran will be marketed as OXLUMO™. Clinical trials indicate significant reductions in urinary and plasma oxalate levels, demonstrating a promising safety profile.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced positive topline results from the ILLUMINATE-B Phase 3 study of lumasiran, an investigational RNAi therapeutic for primary hyperoxaluria type 1 (PH1). This trial is significant as it is the first assessing the safety and efficacy of lumasiran in children under six, including infants. The study enrolled 18 young patients and reported a clinically meaningful reduction in urinary oxalate levels. Lumasiran has received various FDA and EMA designations and a New Drug Application is pending with the FDA, set for review by December 3, 2020.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced its participation in the Chardan Virtual 4th Annual Genetic Medicines Conference on October 5, 2020, at 4:15 PM ET. The company's management will provide a comprehensive overview during this event. A live audio webcast will be available on the Investors section of Alnylam's website, with a replay accessible within 48 hours post-presentation. Alnylam is at the forefront of RNA interference therapeutics, committed to innovating treatments for genetic and other serious diseases.