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, Inc. (Nasdaq: ALNY) is at the forefront of RNA interference (RNAi) therapeutics, pioneering a transformative class of medicines aimed at treating and potentially curing a wide range of diseases. Founded in 2002 and based in Cambridge, MA, Alnylam has translated Nobel Prize-winning science into five commercial products: ONPATTRO (patisiran), AMVUTTRA (vutrisiran), GIVLAARI (givosiran), OXLUMO (lumasiran), and Leqvio (inclisiran), developed and commercialized in partnership with Novartis. These breakthrough therapeutics address conditions such as hATTR amyloidosis, acute hepatic porphyria, primary hyperoxaluria type 1, and hypercholesterolemia.
Alnylam is dedicated to expanding its pipeline with several investigational medicines in late-stage development, focusing on genetic medicines, cardio-metabolic diseases, hepatic infectious diseases, and CNS/ocular diseases. The company’s commitment to sustainable innovation is reflected in its robust product pipeline and strategic collaborations with industry leaders like Roche and Regeneron.
Financially, Alnylam reported robust growth in 2023 with $1.24 billion in global net product revenues, a reflection of its strong commercial execution across its therapeutic products. The company maintains a strong cash position, bolstered by upfront fees from research partnerships and milestone achievements.
Alnylam is also dedicated to corporate responsibility, with initiatives aimed at reducing greenhouse gas emissions, promoting diversity and inclusion in clinical trials, and expanding global health equity through its Alnylam Challengers program. The company’s environmental impact data is third-party verified, underscoring its commitment to transparency and sustainability.
Looking ahead, Alnylam aims to sustain its leadership in RNAi therapeutics with the anticipated release of topline results from the HELIOS-B Phase 3 study and the continued development of promising candidates like zilebesiran for hypertension and mivelsiran for Alzheimer’s disease. For more details on Alnylam’s people, science, and pipeline, visit www.alnylam.com.
On December 3, 2020, Orsini Specialty Pharmacy announced its selection by Alnylam Pharmaceuticals as a limited distribution partner for OXLUMO™ (lumasiran), the first approved treatment for primary hyperoxaluria type 1 (PH1). This ultra-rare genetic disease affects 1-3 individuals per million in the U.S. and Europe. OXLUMO is an RNAi therapeutic designed to lower urinary oxalate levels. It showcases Alnylam's commitment to innovative medicines and technology, enhancing the treatment landscape for rare diseases.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced the completion of patient enrollment in the ILLUMINATE-C Phase 3 study of lumasiran, an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1), for treating advanced primary hyperoxaluria type 1 (PH1). The trial enrolled 21 patients across 13 sites in 10 countries. This milestone is significant for evaluating lumasiran's efficacy in severe PH1 cases, particularly those on dialysis. Lumasiran is already approved in the U.S. and EU under the brand OXLUMO™.
Alnylam Pharmaceuticals (Nasdaq: ALNY) will present an overview at the 43rd Nasdaq Virtual Investor Conference on December 4, 2020, at 11:00 am ET. Investors can access the live audio webcast on the company’s website, with a replay available within 48 hours. Alnylam is a pioneer in RNA interference (RNAi) therapeutics, developing innovative medicines for severe diseases. Their commercial products include ONPATTRO®, GIVLAARI®, and OXLUMO™, along with a robust pipeline of investigational medicines aimed at addressing unmet patient needs.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has unveiled a new framework for value-based agreements (VBAs) to ensure access to OXLUMO™ (lumasiran) for patients with primary hyperoxaluria type 1 (PH1). Approved by the FDA, OXLUMO is the first targeted therapy for PH1, aimed at reducing urinary oxalate levels. Alnylam has engaged with key payers, including Express Scripts and Highmark, to establish VBAs that enhance budget predictability and align pricing with value. Approximately 1,000-1,700 individuals with PH1 in the U.S. are potential candidates for treatment, emphasizing the need for innovative access solutions.
Alnylam Pharmaceuticals announced FDA approval of OXLUMO™ (lumasiran) for treating primary hyperoxaluria type 1 (PH1). This injectable therapy is the first to target urinary oxalate levels in both pediatric and adult patients. In the pivotal ILLUMINATE-A study, OXLUMO achieved a 65% reduction in urinary oxalate versus 12% with placebo, demonstrating significant efficacy. The drug also showed a favorable safety profile, with injection site reactions being the most common side effect. OXLUMO is set for distribution by year-end and has received multiple designations, including Breakthrough Therapy.
Alnylam Pharmaceuticals (ALNY) has received marketing authorization from the European Commission for OXLUMO™ (lumasiran), an RNAi therapeutic aimed at treating primary hyperoxaluria type 1 (PH1), an ultra-rare disease. This approval fills a significant gap as there were previously no approved treatment options for PH1 in Europe. Clinical studies, ILLUMINATE-A and ILLUMINATE-B, showed lumasiran significantly reduced urinary oxalate levels. Alnylam intends to work with health authorities across Europe to ensure patient access while minimizing budget uncertainty for health services.
Alnylam Pharmaceuticals (Nasdaq: ALNY) reported positive interim data from its Phase 1 study of ALN-AGT, an RNAi therapeutic targeting angiotensinogen for hypertension treatment. Presented at the AHA Scientific Sessions 2020, data from 60 patients revealed significant AGT knockdown of up to 97.6% and considerable systolic and diastolic blood pressure reductions at 200 mg doses. The treatment demonstrated a favorable safety profile, with mild, transient adverse events observed. These results suggest a potential for innovative hypertension management with infrequent dosing, addressing the unmet need for improved patient adherence.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announces virtual presentations at two upcoming conferences. The 29th Annual Credit Suisse Virtual Healthcare Conference is scheduled for November 9, 2020, at 12:30 pm ET, followed by the Stifel 2020 Virtual Healthcare Conference on November 16, 2020, at 2:00 pm ET. Investors can access a live audio webcast of each presentation on Alnylam's website, with replays available within 48 hours post-event. Alnylam is a leader in RNA interference therapeutics, focused on innovative medicines for rare genetic and other severe diseases.