Alnylam Pharmaceuticals Inc Stock Price, News & Analysis

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 July 14, 2022, due to regulatory amendments concerning a third-party packaging facility. No FDA-requested clinical data is pending, and a new facility has been identified. Vutrisiran is also under review by the European Medicines Agency, the Brazilian Health Regulatory Agency, and the Japanese Pharmaceuticals and Medical Devices Agency.

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.