Alnylam Pharmaceuticals Inc Stock Price, News & Analysis

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.

Alnylam Pharmaceuticals (Nasdaq: ALNY) has initiated the KARDIA-1 Phase 2 study to evaluate the safety and efficacy of zilebesiran, an RNAi therapeutic for treating hypertension. The trial will assess blood pressure changes in approximately 375 participants over 12 months. Key endpoints include systolic blood pressure reduction after three months. This study follows promising Phase 1 results presented earlier this year. The global trial will be conducted in the U.S. and Europe and aims to address the high unmet need for effective hypertension management.

Alnylam Pharmaceuticals (Nasdaq: ALNY) announced that the FDA has accepted its New Drug Application for vutrisiran, an investigational RNAi therapeutic targeting hereditary transthyretin-mediated (hATTR) amyloidosis. The FDA has set an action date of April 14, 2022, and will not hold an advisory committee meeting for this review. Vutrisiran has received Orphan Drug and Fast-Track designations. The HELIOS-A Phase 3 study evaluates vutrisiran's efficacy, with promising results expected to provide a new treatment option for hATTR patients.