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.
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.
Alnylam Pharmaceuticals announced promising results from the APOLLO-B Phase 3 study of patisiran for treating ATTR amyloidosis with cardiomyopathy. The 12-month data showed favorable impacts on cardiac stress and injury biomarkers, NT-proBNP and Troponin I, with reductions in mean fold changes versus placebo. Patisiran also demonstrated consistent benefits across patient subgroups for functional capacity and quality of life metrics. The treatment exhibited a good safety profile. Alnylam plans to submit a supplemental new drug application to the FDA for patisiran by late 2022.
Alnylam Pharmaceuticals (NASDAQ: ALNY) announced the appointments of Piyush Sharma as Chief Ethics and Compliance Officer and Evan Lippman as Chief Corporate Development and Strategy Officer. Both executives will report to CEO Yvonne Greenstreet. Sharma brings over 20 years of compliance experience from Alexion Pharmaceuticals, while Lippman has extensive corporate development experience from Intima Bioscience and Takeda Pharmaceuticals. These strategic hires aim to bolster Alnylam's P5x25 strategy for delivering transformative RNAi therapeutics.
Alnylam Pharmaceuticals has received marketing authorization from the European Commission for AMVUTTRA (vutrisiran), an RNAi therapeutic for hereditary transthyretin-mediated (hATTR) amyloidosis in adults with polyneuropathy. This decision follows a positive opinion from the EMA in July 2022. The authorization is supported by 18-month data from the HELIOS-A Phase 3 study, which indicated significant improvement in neuropathy impairment for over 50% of patients. The therapy allows quarterly subcutaneous administration, enhancing patient treatment adherence.
Alnylam Pharmaceuticals has announced its 9th annual 'RNAi Roundtable' webinar series starting September 27, 2022. This series will feature discussions on pipeline programs, RNAi platform innovations, and clinical developments. Key sessions include:
- Cemdisiran for IgA Nephropathy - September 27, 2022
- Leadership in RNAi - October 21, 2022
- CNS Delivery for Alzheimer’s - November 1, 2022
A virtual R&D Day is scheduled for December 15, 2022, focusing on RNAi pipeline advancements. More details are available on their website.
Alnylam and Regeneron have released preliminary Phase 1 results for ALN-HSD, an RNAi therapeutic targeting HSD17B13, aimed at treating nonalcoholic steatohepatitis (NASH).
The study showed promising outcomes, with robust target knockdown and reduced liver enzymes over six months in 20 patients compared to 4 in the placebo group.
Following this success, a Phase 2 study is set to commence in late 2022. Safety data indicated mild injection site reactions, with no serious adverse events reported, further validating ALN-HSD's potential in addressing NASH's significant unmet medical needs.
Regeneron (REGN) and Alnylam (ALNY) announced positive preliminary data from a Phase 1 study of ALN-HSD, aimed at treating nonalcoholic steatohepatitis (NASH). Results show robust target knockdown and lower liver enzymes in patients receiving ALN-HSD compared to placebo, with a favorable safety profile. The companies plan to advance to a Phase 2 trial in late 2022. The study highlighted a significant unmet need in NASH, which affects 16 million people in the U.S. and is projected to be a leading cause of liver transplants.
Alnylam Pharmaceuticals (NASDAQ: ALNY) will present new data from the APOLLO-B Phase 3 study of patisiran at the HFSA Annual Scientific Meeting on
Alnylam Pharmaceuticals (Nasdaq: ALNY) has announced the pricing of a $900 million private offering of 1.00% convertible senior notes due in 2027. The offering allows initial purchasers to buy an additional $135 million of the notes. The notes will accrue interest payable semi-annually and will be convertible under specified conditions. Proceeds are projected to be approximately $883.2 million, intended for capped call transactions and to repay existing borrowings. Closing is expected on September 15, 2022, pending customary conditions.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has initiated a private offering of $900 million in convertible senior notes due 2027, with an option for initial purchasers to acquire an additional $135 million. The notes, which are senior and unsecured, will mature on September 15, 2027, and interest will be paid semi-annually. Alnylam plans to use around $762 million of the proceeds to repay existing borrowings and for general corporate purposes. The offering is under Rule 144A and is contingent upon market conditions.
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