Alnylam Pharmaceuticals develops and commercializes RNA interference (RNAi) therapeutics, with news centered on its approved medicines, TTR franchise, clinical pipeline and financial performance. Company updates commonly address AMVUTTRA/vutrisiran and ONPATTRO/patisiran for transthyretin-mediated amyloidosis, GIVLAARI/givosiran for acute hepatic porphyria, OXLUMO/lumasiran for primary hyperoxaluria type 1, and partner-commercialized RNAi medicines.
Recurring developments include quarterly product revenue reports, guidance, clinical and real-world data for ATTR-CM and other cardiovascular programs, pipeline progress across cardio-metabolic disease, neuroscience and hematology, disease-awareness collaborations, and investor conference presentations. Alnylam also reports on its Alnylam 2030 strategy and commercialization of RNAi medicines in global markets.
Alnylam Pharmaceuticals reported a significant Q3 2021 revenue of $167 million for its products ONPATTRO, GIVLAARI, and OXLUMO. The company highlighted promising 18-month results from the HELIOS-A Phase 3 study of vutrisiran in patients with hATTR amyloidosis. Global net product revenues for ONPATTRO rose 6% to $120 million, while GIVLAARI grew 4% to $32 million. However, OXLUMO saw a 9% decline in revenue. Alnylam reaffirmed its 2021 guidance of $640-$665 million in revenues and announced a leadership transition from CEO John Maraganore to Yvonne Greenstreet.
Alnylam Pharmaceuticals announces a leadership transition with CEO John Maraganore passing the reins to Yvonne Greenstreet by year-end 2021. Maraganore, a founding figure since 2002, has led the development of RNAi therapeutics, contributing to the approval of four medicines in 25 countries. Greenstreet, currently President and COO, brings significant experience and will step into her new role while Maraganore continues as a consultant until March 2022. The Board expressed strong confidence in Greenstreet's leadership to advance Alnylam’s P5x25 strategy.
Alnylam Pharmaceuticals announced that the HELIOS-A Phase 3 study of vutrisiran met all 18-month secondary endpoints. Significant improvements were observed in neuropathy, quality of life, gait speed, nutritional status, and overall disability compared to external placebo data. Additionally, vutrisiran showed positive exploratory endpoint results, including improved NT-proBNP levels and technetium uptake, indicating reduced cardiac amyloid burden. The drug has an encouraging safety profile, with minimal discontinuations due to adverse events. Full results are expected to be presented at an upcoming medical conference.
Alnylam Pharmaceuticals (NASDAQ: ALNY) will announce its third-quarter financial results for 2021 on October 28, 2021, before U.S. markets open. The company will host a conference call at 8:30 am ET to discuss results and future expectations. Investors can access the live call by dialing 877-312-7507 (domestic) or +1-631-813-4828 (international), with a replay available later in the day. Alnylam develops innovative RNA interference (RNAi) therapeutics aimed at addressing severe diseases, with a commitment to delivering transformative medicines through its ongoing pipeline.
Alnylam Pharmaceuticals (NASDAQ: ALNY) has launched the Alnylam Challengers program, committing $1 million to Acumen America to enhance health equity initiatives. This partnership aims to assist 75 million individuals in the U.S. by 2024 by tackling health disparities due to poverty and discrimination. The program includes a Social Investment Portfolio, an Advisory Corps for expert volunteering, and cross-sector Convenings to address health equity issues. Alnylam emphasizes its corporate responsibility and investment in sustainable health solutions.
Alnylam Pharmaceuticals announced promising pre-clinical research at the 17th Annual Meeting of the Oligonucleotide Therapeutics Society, showcasing innovations in RNAi therapeutics. Their hexadecyl (C16) conjugate demonstrates over 90% target knockdown potential in the CNS with an annual dosing regimen. The presentation also highlighted the IKARIA platform, which facilitates effective siRNA delivery. Additionally, pre-clinical data on ALN-APP for early-onset Alzheimer's Disease showed promising results, with plans for a clinical trial application later this year.
Alnylam Pharmaceuticals (Nasdaq: ALNY) will present a company overview at the Chardan Virtual 5th Annual Genetic Medicines Conference on Tuesday, October 5, 2021, at 2:30 pm ET. The presentation will be accessible via a live audio webcast on the Investors section of Alnylam's website, with a replay available within 48 hours post-event. Alnylam is a leader in RNA interference therapeutics, developing innovative treatments for rare diseases and more, including commercial products like ONPATTRO®, GIVLAARI®, and OXLUMO®. The company aims to transform medicine through its robust RNAi platform.
Alnylam Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for vutrisiran, aimed at treating hereditary transthyretin-mediated (hATTR) amyloidosis in adults. This investigational RNAi therapeutic shows promise, having met primary and secondary endpoints in the HELIOS-A Phase 3 study, including improvements in neuropathy and quality of life at 9 months. Vutrisiran has Orphan Drug Designation in the EU and U.S. and a New Drug Application is under review by the FDA, set for action on April 14, 2022.
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.