Alnylam Pharmaceuticals Inc - ALNY STOCK NEWS

Alnylam Pharmaceuticals reported Q3 2022 global net product revenues of $232 million, a 39% increase year-over-year. AMVUTTRA achieved $25 million in revenue, driving a 30% increase in U.S. TTR growth from Q2. Positive results were announced from the APOLLO-B Phase 3 study of patisiran, with an sNDA submission planned by year-end. The company reiterated its 2022 combined net product revenue guidance of $870-$930 million. Research and development expenses rose, while cash and equivalents were $2.27 billion as of September 30, down from $2.44 billion at the year's start.

Alnylam Pharmaceuticals (NASDAQ: ALNY) will report its third-quarter financial results on October 27, 2022, before U.S. market opening. The management will hold a conference call on the same date at 8:30 am ET to discuss the results and future expectations. A live audio webcast will be available on the company's investor website. Alnylam continues to lead in RNA interference therapeutics, offering products like ONPATTRO and GIVLAARI, and has a robust pipeline with six late-stage candidates. The firm is committed to developing innovative medicines for rare diseases.

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.