Alnylam Pharmaceuticals Inc - ALNY STOCK NEWS

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.

Alnylam Pharmaceuticals (Nasdaq: ALNY) is set to host its 8th annual series of RNAi Roundtable webinars featuring presentations from its scientists and medical thought leaders. The webinars will review progress in its pipeline programs and the advancements in RNAi therapeutics. Events are scheduled from June 30 to October 1, highlighting topics like ALN-AGT for hypertension and Givosiran for acute hepatic porphyria. Each event will be live-streamed, with a replay available on the company’s website within three hours post-event.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced positive findings from a Phase 3b study on patisiran, showing a 91% median reduction in serum TTR levels in hereditary ATTR amyloidosis patients post-liver transplant. The study, involving 23 patients, demonstrated improvements in neuropathy and quality of life over 12 months. Additionally, results from the HELIOS-A Phase 3 study of vutrisiran indicated consistent improvements across multiple patient subgroups, highlighting its potential as a new treatment. These findings may lead to important label changes for ONPATTRO in various markets.

Alnylam Pharmaceuticals (Nasdaq: ALNY) has completed patient enrollment in the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic targeting ATTR amyloidosis. Over 300 patients participated across 90 sites in more than 20 countries. The study aims to evaluate the efficacy and safety of patisiran for treating cardiomyopathy in ATTR amyloidosis patients. Notably, the primary outcome measures will include changes in the 6-minute walk test compared to placebo. Topline results are anticipated in mid-2022, marking crucial progress for both the treatment and the company's pipeline.

Alnylam Pharmaceuticals (Nasdaq: ALNY) announced upcoming presentations at several virtual healthcare conferences. Key dates include:

• Jefferies Virtual Healthcare Conference on June 1, 2021, at 2:30 PM ET
• Bernstein 37th Annual Strategic Decisions Conference on June 3, 2021, at 9:00 AM ET
• Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021, at 10:30 AM ET
• 44th Nasdaq Investor Conference on June 15, 2021, at 10:00 AM ET

Webcasts will be available on the company's investor website, with replays accessible within 48 hours post-event.

Alnylam Pharmaceuticals (Nasdaq: ALNY) announced the initiation of a clinical study for a biannual dosing regimen of vutrisiran, targeting hereditary transthyretin-mediated amyloidosis (hATTR). This follows positive results from the HELIOS-A Phase 3 study using a quarterly dosing regimen. The biannual regimen aims to align treatment frequency with patient visits, potentially enhancing adherence. The company is also advancing a pre-clinical program using the IKARIA platform to achieve over 90% TTR reduction with annual dosing. Positive RTE results are expected in 2022, supporting potential additional regulatory filings.