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 (ALNY) has submitted a Clinical Trial Authorization application to Health Canada to initiate a Phase 1/2 study of ALN-KHK, an investigational RNAi therapeutic for Type 2 diabetes mellitus (T2DM). The study is set to enroll healthy and obese patients in early 2023, with initial results expected by late 2023. ALN-KHK targets ketohexokinase to potentially improve glycemic control. With T2DM affecting over 450 million globally, the need for effective treatments remains critical. Alnylam aims to innovate in the RNAi therapeutic space, leveraging new technologies.
Alnylam Pharmaceuticals hosted its R&D Day, outlining goals for 2023, including a potential label expansion and plans to report ten clinical datasets from its RNAi platform. The company aims for strong commercial execution across four brands and anticipates FDA approval for Patisiran to treat cardiomyopathy associated with ATTR amyloidosis in late 2023. Alnylam also plans to advance investigational therapies for various conditions including hypertension, Alzheimer's, and Type 2 diabetes. The webcast of the event is available online.
Alnylam Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran, an investigational RNAi therapeutic aimed at treating transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. This follows positive results from the Phase 3 APOLLO-B study, which demonstrated significant improvements in functional capacity and quality of life at 12 months. The study also showed an encouraging safety profile, with most adverse events being mild to moderate. Patisiran is already FDA approved for polyneuropathy of hereditary ATTR amyloidosis.
Alnylam Pharmaceuticals has announced a virtual R&D Day scheduled for December 15, 2022, at 8:30 am ET, which will be webcast on the company's website. A replay will be available within 48 hours post-event. Alnylam, a leader in RNA interference therapeutics, aims to transform treatments for rare and common diseases. The company has developed several commercial products and has a robust pipeline of investigational medicines. To learn more, visit www.alnylam.com.
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Alnylam Pharmaceuticals (Nasdaq: ALNY) has announced its participation in multiple healthcare conferences. On November 16, 2022, the company will present at both the Jefferies London Healthcare Conference and Stifel 2022 Healthcare Conference at 2:05 pm GMT and 1:15 pm ET, respectively. Additionally, Alnylam will engage in the Evercore ISI HealthCONx Conference on November 29, and the Piper Sandler Healthcare Conference on November 30. A live audio webcast of these events will be available on Alnylam's website.
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Alnylam Pharmaceuticals reported Q3 2022 global net product revenues of $232 million, a 39% increase year-over-year. AMVUTTRA achieved $25 million in revenue, driving a 30% increase in U.S. TTR growth from Q2. Positive results were announced from the APOLLO-B Phase 3 study of patisiran, with an sNDA submission planned by year-end. The company reiterated its 2022 combined net product revenue guidance of $870-$930 million. Research and development expenses rose, while cash and equivalents were $2.27 billion as of September 30, down from $2.44 billion at the year's start.
Alnylam Pharmaceuticals (NASDAQ: ALNY) will report its third-quarter financial results on October 27, 2022, before U.S. market opening. The management will hold a conference call on the same date at 8:30 am ET to discuss the results and future expectations. A live audio webcast will be available on the company's investor website. Alnylam continues to lead in RNA interference therapeutics, offering products like ONPATTRO and GIVLAARI, and has a robust pipeline with six late-stage candidates. The firm is committed to developing innovative medicines for rare diseases.
Alnylam Pharmaceuticals announced the FDA's approval of a label expansion for OXLUMO (lumasiran) to treat Primary Hyperoxaluria Type 1 (PH1), aimed at reducing urinary and plasma oxalate levels in both pediatric and adult patients. The approval is supported by positive results from the ILLUMINATE-C Phase 3 study, which demonstrated significant reductions in plasma oxalate among patients with severe renal impairment, including those on hemodialysis. This marks OXLUMO as the first FDA-approved treatment for PH1.