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 (Nasdaq: ALNY) reported positive 18-month findings from the HELIOS-A Phase 3 study of vutrisiran, an investigational RNAi therapeutic for hereditary ATTR amyloidosis. The analysis indicated significant improvements in NT-proBNP levels, a key cardiac stress marker, in patients treated with vutrisiran compared to an external placebo. Cardiac echocardiographic parameters also showed favorable trends. Vutrisiran treatment reduced cardiac technetium uptake, suggesting benefits for patients with high amyloid burden. The drug has Orphan Drug Designation and is undergoing review by regulatory authorities, with a PDUFA date of July 14, 2022.
Alnylam Pharmaceuticals (NASDAQ: ALNY) announced key presentations at three upcoming conferences. Management will provide company overviews at the BofA Securities 2022 Healthcare Conference on May 11, 2022, at 11:20 am PT in Las Vegas, at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 7:00 am ET virtually, and at the UBS Global Healthcare Conference on May 25, 2022, at 10:00 am ET in New York. Live audio webcasts will be available on the company’s website, with replays accessible within 48 hours.
Alnylam Pharmaceuticals reported Q1 2022 global net product revenues of $187 million, driven by ONPATTRO, GIVLAARI, and OXLUMO. Positive results from the HELIOS-A Phase 3 study of vutrisiran were also announced, indicating improvements in neuropathy impairment and quality of life for patients. However, the company has lowered its 2022 revenue guidance from $900-$1 billion to $870-$930 million. The FDA extended the review period for vutrisiran due to pending inspection issues, now targeting a July 14, 2022 decision.
Alnylam Pharmaceuticals (NASDAQ: ALNY) is set to report its first-quarter financial results for 2022 on April 28, 2022, before U.S. markets open. The company will also host a conference call at 8:30 AM ET to discuss these results and future expectations. Investors can access the live audio webcast via Alnylam's website. Alnylam is recognized for its innovative RNA interference (RNAi) therapies and has a robust pipeline with six candidates in late-stage development.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced the retirement of Steven Paul, M.D. from its Board of Directors effective April 16, 2022. Dr. Paul has served on the board since September 2010, contributing over 25 years of management experience in the pharmaceutical sector. His leadership has been crucial in guiding Alnylam's growth, including the launch of three products in recent years. CEO Yvonne Greenstreet acknowledged his significant contributions and wished him well in his future endeavors.
Alnylam Pharmaceuticals announced an extension of the New Drug Application (NDA) review for vutrisiran, an investigational treatment for transthyretin-mediated amyloidosis (ATTR). The new Prescription Drug User Fee Act (PDUFA) goal date is
Alnylam Pharmaceuticals (Nasdaq: ALNY) will present an overview of the company at the Stifel 2022 CNS Days on March 28, 2022, at 2:00 pm ET. This presentation will be available via a live audio webcast on the company’s Investors section. A replay will be accessible within 48 hours post-event. Alnylam is a leader in RNA interference therapeutics, aiming to transform treatment for rare and prevalent diseases. The company has a rich pipeline and is committed to delivering innovative medicines through its Alnylam P5x25 strategy.
Alnylam Pharmaceuticals (NASDAQ: ALNY) has filed a lawsuit against Pfizer and Moderna in the U.S. District Court for the District of Delaware, claiming patent infringement related to biodegradable cationic lipids essential for mRNA COVID-19 vaccines, specifically U.S. Patent No. 11,246,933. Alnylam seeks compensation for its patented technology but does not intend to disrupt vaccine production. This legal action highlights Alnylam's investment in RNAi therapeutics, a sector poised for growth and innovation in medicine.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has published its 2021 Corporate Responsibility Report, its first full report, highlighting its GHG emissions and sustainability efforts.
Key points include the establishment of baseline GHG emissions, a strengthened corporate responsibility structure, a $1 million investment in health equity initiatives, and enhanced diversity, equity, and inclusion goals.
Alnylam Pharmaceuticals announced that the FDA has accepted its supplemental New Drug Application (sNDA) for lumasiran, an RNAi therapeutic targeting HAO1, aimed at reducing plasma oxalate in patients with advanced primary hyperoxaluria type 1 (PH1). The FDA has set a PDUFA action date for October 6, 2022. The six-month results from the ILLUMINATE-C study demonstrated significant reductions in plasma oxalate levels for patients, including those on hemodialysis. Alnylam also submitted a Type II Variation to the EMA for lumasiran's label amendment.