Alnylam Pharmaceuticals, Inc. - ALNY STOCK NEWS

Alnylam Pharmaceuticals (Nasdaq: ALNY) will present a company overview at the Chardan Virtual 5th Annual Genetic Medicines Conference on Tuesday, October 5, 2021, at 2:30 pm ET. The presentation will be accessible via a live audio webcast on the Investors section of Alnylam's website, with a replay available within 48 hours post-event. Alnylam is a leader in RNA interference therapeutics, developing innovative treatments for rare diseases and more, including commercial products like ONPATTRO®, GIVLAARI®, and OXLUMO®. The company aims to transform medicine through its robust RNAi platform.

Alnylam Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for vutrisiran, aimed at treating hereditary transthyretin-mediated (hATTR) amyloidosis in adults. This investigational RNAi therapeutic shows promise, having met primary and secondary endpoints in the HELIOS-A Phase 3 study, including improvements in neuropathy and quality of life at 9 months. Vutrisiran has Orphan Drug Designation in the EU and U.S. and a New Drug Application is under review by the FDA, set for action on April 14, 2022.

Alnylam Pharmaceuticals announced encouraging results from its HELIOS-A Phase 3 study of vutrisiran, targeting hereditary transthyretin-mediated (ATTR) amyloidosis. The study demonstrated statistically significant improvements in patient health outcomes, including neuropathy impairment and quality of life, after 9 months. Notably, improvements were consistent regardless of prior TTR stabilizer use. The company aims to release 18-month results later this year, with the FDA accepting its New Drug Application for vutrisiran, and an EU submission planned ahead of schedule.

Alnylam Pharmaceuticals (Nasdaq: ALNY) will present company overviews at several virtual conferences in September 2021. Key presentation dates include the Morgan Stanley 19th Annual Global Healthcare Conference on September 9 at 3:30 PM ET, H.C. Wainwright's 23rd Annual Global Investment Conference on September 13 at 7:00 AM ET, BofA Global Healthcare Conference on September 16 at 10:05 AM ET, and Cantor Virtual Global Healthcare Conference on September 28 at 10:40 AM ET. Live webcasts will be available on the company's website, with replays accessible within 48 hours.

Alnylam Pharmaceuticals (Nasdaq: ALNY) achieved full enrollment in its HELIOS-B Phase 3 study for vutrisiran, an RNAi therapeutic aimed at treating cardiomyopathy in patients with ATTR amyloidosis. Over 600 patients were enrolled across 123 sites in 32 countries, ahead of schedule. The study will assess vutrisiran's efficacy against placebo, focusing on all-cause mortality and cardiovascular events over 30 months. Topline results are anticipated in early 2024, with potential interim analyses linked to the APOLLO-B study. This milestone reflects strong interest in innovative treatment options.

Alnylam Pharmaceuticals (ALNY) reported strong second-quarter results for 2021, with total net product revenues of $160.8 million, a 107% increase year-over-year. ONPATTRO, GIVLAARI, and OXLUMO all showed significant growth, with ONPATTRO revenues rising to $114 million, GIVLAARI to $31 million, and OXLUMO achieving $16 million. The company received marketing approvals for GIVLAARI in Japan and OXLUMO in Brazil. Alnylam also raised its revenue guidance for the year to between $640 million and $665 million. Despite a GAAP net loss of $189.6 million, positive developments in their clinical pipeline and collaborations with Regeneron and Novartis are promising.

Alnylam Pharmaceuticals (Nasdaq: ALNY) has entered into a collaboration with PeptiDream to develop peptide-siRNA conjugates for RNAi therapeutics targeting various tissues outside the liver. Alnylam will select receptors for PeptiDream's platform, which will optimize peptides for targeted delivery. This partnership aims to leverage PeptiDream's expertise in peptide ligands to expand treatment opportunities for RNAi therapeutics. The agreement includes an upfront payment and potential milestone payments totaling up to $2.2 billion, along with royalties on future product sales.

Alnylam Pharmaceuticals (Nasdaq: ALNY) announced positive topline results from the ILLUMINATE-C Phase 3 study of lumasiran for advanced primary hyperoxaluria type 1 (PH1). The trial showed significant decreases in plasma oxalate levels after six months in both hemodialysis-dependent and independent patients. The safety profile was encouraging, with mild injection site reactions as the most common adverse event. Alnylam plans to submit a Supplemental New Drug Application to the FDA and EMA based on these results, further solidifying lumasiran's therapeutic potential in treating PH1.

Alnylam Pharmaceuticals (Nasdaq: ALNY) plans to report its second quarter financial results for the period ending June 30, 2021, on August 3, 2021, prior to market opening. A conference call will be held at 8:30 am ET on the same day to discuss the results and future expectations. Alnylam is recognized for its pioneering work in RNA interference therapeutics, which have the potential to treat various rare and severe diseases. The company is advancing its research and commercial efforts with innovative products and a robust pipeline.