Welcome to our dedicated page for Alnylam Pharmaceuticals news (Ticker: ALNY), a resource for investors and traders seeking the latest updates and insights on Alnylam Pharmaceuticals stock.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) regularly issues news on its RNA interference (RNAi) therapeutics, commercial performance, pipeline progress, and corporate developments. As a company that has led the RNAi field from discovery to approved medicines, its announcements often highlight data from pivotal trials, regulatory milestones, and updates on marketed products such as AMVUTTRA, ONPATTRO, GIVLAARI, and OXLUMO.
Investors following ALNY news can expect detailed coverage of clinical results across multiple therapeutic areas, including transthyretin‑mediated amyloidosis (ATTR), hypertension, bleeding disorders, neurological diseases, and metabolic conditions. Recent releases have described post hoc analyses from the HELIOS‑B Phase 3 study of AMVUTTRA in ATTR‑CM and hATTR‑PN, showing effects on gastrointestinal events, cardiac structure and function, and renal outcomes, as well as broader safety and efficacy profiles.
Alnylam’s news flow also includes financial and strategic updates. The company reports quarterly and annual net product revenues, trends in its TTR and rare disease franchises, and guidance associated with frameworks such as its Alnylam P5x25 and Alnylam 2030 strategies. Filings and press releases have discussed convertible senior notes, a revolving credit facility, and partial repurchases of outstanding debt, providing context on capital structure and liquidity.
Operational and manufacturing developments are another key news theme. Alnylam has announced expansion of its Norton, Massachusetts siRNA manufacturing facility and the integration of its siRELIS enzymatic ligation platform, which has been accepted into the FDA’s Emerging Technology Program. Corporate governance items, such as changes to the Board of Directors and executive responsibilities, are also disclosed. For anyone tracking ALNY, this news stream offers insight into clinical milestones, commercial execution, manufacturing scale‑up, and strategic direction in RNAi therapeutics.
Alnylam Pharmaceuticals announced positive results from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic for treating ATTR amyloidosis with cardiomyopathy. The study met its primary endpoint, showing a significant improvement in functional capacity (14.7 meters in 6-MWT) and health status (3.7 points in KCCQ-OS) compared to placebo after 12 months. Safety profiles were encouraging, with no major cardiac concerns. A supplemental new drug application is planned, indicating a potential market opportunity for patisiran if approved.
Alnylam Pharmaceuticals (NASDAQ: ALNY) will present a company overview at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 11:10 am ET. The event will take place at the Sheraton New York Hotel. Investors can access a live audio webcast on the company’s website, with a replay available within 48 hours post-event. Alnylam is known for pioneering RNA interference (RNAi) therapeutics, addressing rare diseases with innovative products like ONPATTRO and GIVLAARI.
Alnylam Pharmaceuticals announced positive results from a Phase 2 study of cemdisiran for treating immunoglobulin A nephropathy (IgAN). The study demonstrated a 37% reduction in the 24-hour urine protein to creatinine ratio compared to placebo. Notably, 32% of patients on cemdisiran achieved a significant reduction in protein levels, compared to 13% on placebo. The treatment was well tolerated, with common side effects being injection site reactions. Alnylam aims to advance cemdisiran to Phase 3 development, addressing the significant unmet needs in IgAN treatment.
Alnylam Pharmaceuticals has appointed Dr. Elliott Sigal to its Board of Directors, enhancing its leadership at a pivotal moment. With decades of experience, including his role as Chief Scientific Officer at Bristol-Myers Squibb, Dr. Sigal contributed to the launch of 14 new medicines across various therapeutic areas. His expertise is expected to strengthen Alnylam's ongoing efforts in advancing RNAi therapeutics aimed at rare diseases. The company continues its pursuit of transforming healthcare through innovative treatments, guided by its 'Alnylam P5x25' strategy.
Alnylam Pharmaceuticals has announced the presentation of data from the APOLLO-B Phase 3 study of patisiran at the 18th International Symposium on Amyloidosis on September 8, 2022. This investigational RNAi therapeutic targets transthyretin-mediated amyloidosis with cardiomyopathy. The company will also present findings from the Global Open-Label Extension study and a multicenter observational study on patients with hATTR amyloidosis. A conference call to discuss results will occur on September 8, 2022, at 8:00 a.m. ET.
Alnylam Pharmaceuticals announced that the APOLLO-B Phase 3 study of patisiran met its primary endpoint, showing a statistically significant improvement in the 6-Minute Walk Test compared to placebo at 12 months (p-value 0.0162). The study also achieved its first secondary endpoint, indicating improved quality of life via the Kansas City Cardiomyopathy Questionnaire (p-value 0.0397). The company plans to file a Supplemental New Drug Application in the U.S. in late 2022. Patisiran demonstrated a favorable safety profile, with fewer deaths in the treatment arm.
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Alnylam Pharmaceuticals reported Q2 2022 net product revenues of $214 million, a 33% increase year-over-year, driven by strong performance from ONPATTRO and GIVLAARI. The company received FDA approval for AMVUTTRA, marking its fifth RNAi therapeutic. Alnylam expects topline results from the APOLLO-B Phase 3 trial of patisiran within three weeks and reiterated its 2022 financial guidance of combined net product revenues between $870 million and $930 million.
Alnylam Pharmaceuticals has published research in Nature Communications indicating that individuals with mutations in the INHBE gene exhibit reduced abdominal fat, a favorable metabolic profile, and lower risks for cardiovascular disease and type 2 diabetes. The study, which analyzed data from over 360,000 people, suggests that targeting INHBE may provide new therapeutic options for cardiometabolic diseases. Alnylam aims to develop a candidate targeting INHBE using its IKARIA™ platform.
This breakthrough highlights the potential to address obesity and its associated health risks effectively.
Alnylam Pharmaceuticals (NASDAQ: ALNY) announced a positive opinion from the European Medicines Agency's CHMP for its RNAi therapeutic, vutrisiran, aimed at treating hATTR amyloidosis in adult patients. The European Commission's decision is expected in September 2022. Vutrisiran is notable for being the first treatment to show reversal in neuropathy impairment with quarterly subcutaneous administration. This therapy met all study endpoints in the HELIOS-A Phase 3 trial, demonstrating safety and efficacy. Vutrisiran is already approved in the U.S. and is under review in Brazil and Japan.