Alnylam Pharmaceuticals, Inc. - ALNY STOCK NEWS

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.

Alnylam Pharmaceuticals (Nasdaq: ALNY) revealed plans for management to present at two upcoming virtual conferences. The events are the BofA Health Care Conference on May 11, 2021, at 2:45 pm ET and the UBS Global Healthcare Virtual Conference on May 25, 2021, at 3:00 pm ET. Investors can access the live audio webcast on the company's website, with a replay available within 48 hours post-event. Alnylam is at the forefront of RNA interference therapeutics, focusing on innovative medicines for rare genetic and other diseases with a diverse pipeline of investigational products.

Alnylam Pharmaceuticals (Nasdaq: ALNY) announced promising early results from the 12-month analysis of the ILLUMINATE-A Phase 3 study of OXLUMO (lumasiran), targeting primary hyperoxaluria type 1 (PH1). The data, presented at the ASPN/PAS virtual meeting, revealed significant reductions in urinary oxalate levels among patients, with notable improvements in nephrocalcinosis observed in 46% of those treated for 12 months. OXLUMO's safety profile remains acceptable, with injection site reactions being the most common adverse effect. Alnylam anticipates reporting further data later this year.

Alnylam Pharmaceuticals reported strong first-quarter 2021 results, with total net product revenues of $135.8 million, marking an 89% increase year-over-year. ONPATTRO drove growth with revenues of $102 million, up 13% quarter-over-quarter. OXLUMO's initial launch generated $9 million in revenues. The company filed an NDA for vutrisiran, with positive HELIOS-A Phase 3 results and accelerated enrollment in HELIOS-B expected to complete by late 2021. Alnylam aims to transition into a top five biotech by 2025 with its P5x25 strategy while maintaining a strong cash position of $1.71 billion.