Alnylam Pharmaceuticals

H.C. Wainwright maintains Buy rating on Alnylam Pharmaceuticals with $400.00 target, confident in AMVUTTRA's ATTR-CM launch in H2 2025. Alnylam's strategy focuses on 18,000 new ATTR-CM patients annually, positioning AMVUTTRA as first-line treatment. Regulatory submissions to FDA and EMA include Priority Review Voucher. Q2 earnings exceeded expectations, with 2024 revenue guidance of $1.575-$1.65 billion. Alnylam revised ATTR-CM prevalence estimate to over 300,000. InvestingPro data highlights Alnylam's strong financial performance and growth potential.

Alnylam CEO discusses vutrisiran's potential in ATTR-CM, while Merck's RSV prophylactic shows competitive efficacy. Biotech investors focus on autoimmune diseases, and Genentech advocates for a comprehensive approach to drug costs.

Alnylam Pharmaceuticals submitted a Type II Variation to the European Medicines Agency for vutrisiran, an RNAi therapeutic for ATTR amyloidosis with cardiomyopathy, supported by positive phase III HELIOS-B study results. The company already markets vutrisiran in the EU as Amvuttra for hATTR amyloidosis. If approved, vutrisiran could become the new standard of care for ATTR-CM, expanding the eligible patient population and driving growth.

GSK sues Moderna for patent infringement on mRNA vaccine technology, claiming Moderna's COVID-19 vaccines rely on GSK's foundational patents from a team led by Christian Mandl at Novartis. GSK seeks damages and licensing fees.

Vir Biotechnology to present Phase 2 SOLSTICE trial data on tobevibart and elebsiran for chronic hepatitis delta at AASLD's The Liver Meeting in San Diego, Nov 15-19, 2024.

Alnylam Pharmaceuticals submitted a regulatory application to the EMA for vutrisiran to treat ATTR-CM, based on the positive HELIOS-B Phase 3 study. The drug, already approved for hATTR amyloidosis, targets the TTR gene, showing significant reduction in death and cardiovascular events. Alnylam also submitted an sNDA to the FDA for vutrisiran and plans further global submissions.

Alnylam Pharmaceuticals submits Type II Variation to EMA for vutrisiran, an RNAi therapeutic for ATTR amyloidosis with cardiomyopathy, based on positive HELIOS-B study results.

Vir Biotechnology to present Phase 2 SOLSTICE trial data on tobevibart and elebsiran for chronic hepatitis delta at AASLD's The Liver Meeting, highlighting efficacy, safety, and economic burden.

Vir Biotechnology to present Phase 2 SOLSTICE trial data at AASLD, evaluating tobevibart and elebsiran for chronic hepatitis delta. The company aims to improve patient outcomes and advance a functional cure for chronic hepatitis B. Recent developments include FDA approval for an Investigational New Drug application and a Fast Track designation for a novel combination treatment. Vir's financial health presents mixed signals, with more cash than debt but significant revenue decline.