Alnylam Pharmaceuticals Inc Stock Price, News & Analysis

Alnylam Pharmaceuticals announced that the FDA accepted their supplemental New Drug Application (sNDA) for patisiran, which targets ATTR amyloidosis with cardiomyopathy, with a PDUFA date set for October 8, 2023. The FDA noted no review issues and plans to hold an advisory committee meeting regarding the application. The sNDA was supported by positive results from the APOLLO-B Phase 3 study, showing improved functional capacity and quality of life in patients. The adverse event profile remains consistent with previous trials. This acceptance signifies a major milestone for Alnylam in addressing the treatment needs for patients with this condition.

Alnylam Pharmaceuticals (Nasdaq: ALNY) will announce its financial results for Q4 and the year ending December 31, 2022, on February 23, 2023, before U.S. markets open. Management will discuss the results and future expectations during a conference call at 8:30 am ET on the same day, which can be accessed via registration online. Alnylam is recognized for pioneering RNA interference (RNAi) therapeutics with products like ONPATTRO, AMVUTTRA, and others, alongside a robust pipeline under its "Alnylam P5x25" strategy aimed at innovative treatments for various diseases. More information is available on their website.

Alnylam Pharmaceuticals reported preliminary global net product revenues of $894 million for 2022, marking a 35% year-over-year growth. The launch of AMVUTTRA significantly contributed to a 37% increase in total TTR revenue, with $122 million and $69 million from ONPATTRO and AMVUTTRA in Q4 2022. The company maintained a strong balance sheet with $2.2 billion in cash and investments. The CEO expressed optimism about achieving long-term commercial goals.

Alnylam Pharmaceuticals (Nasdaq: ALNY) has appointed Carolyn Bertozzi, Ph.D., a Nobel Laureate, to its Board of Directors. Dr. Bertozzi is renowned for her contributions to chemical biology and has founded multiple biopharmaceutical companies. Additionally, Amy W. Schulman will step into the role of Chair of the Board, succeeding Michael W. Bonney, who will remain as a non-independent director. These leadership changes align with Alnylam's P5x25 strategy aimed at expanding patient access to RNAi therapeutics.

Alnylam Pharmaceuticals (Nasdaq: ALNY) will present an overview and participate in a Q&A session at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:45 am PT (12:45 pm ET) in San Francisco. The presentation will include an update on unaudited global net product revenues for Q4 and full year 2022. A live audio webcast will be available on their website, with a replay accessible within 48 hours. Alnylam is known for pioneering RNA interference therapeutics aimed at treating rare diseases.

Alnylam Pharmaceuticals (ALNY) has submitted a Clinical Trial Authorization application to Health Canada to initiate a Phase 1/2 study of ALN-KHK, an investigational RNAi therapeutic for Type 2 diabetes mellitus (T2DM). The study is set to enroll healthy and obese patients in early 2023, with initial results expected by late 2023. ALN-KHK targets ketohexokinase to potentially improve glycemic control. With T2DM affecting over 450 million globally, the need for effective treatments remains critical. Alnylam aims to innovate in the RNAi therapeutic space, leveraging new technologies.

Alnylam Pharmaceuticals hosted its R&D Day, outlining goals for 2023, including a potential label expansion and plans to report ten clinical datasets from its RNAi platform. The company aims for strong commercial execution across four brands and anticipates FDA approval for Patisiran to treat cardiomyopathy associated with ATTR amyloidosis in late 2023. Alnylam also plans to advance investigational therapies for various conditions including hypertension, Alzheimer's, and Type 2 diabetes. The webcast of the event is available online.

Alnylam Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran, an investigational RNAi therapeutic aimed at treating transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. This follows positive results from the Phase 3 APOLLO-B study, which demonstrated significant improvements in functional capacity and quality of life at 12 months. The study also showed an encouraging safety profile, with most adverse events being mild to moderate. Patisiran is already FDA approved for polyneuropathy of hereditary ATTR amyloidosis.

Alnylam Pharmaceuticals has announced a virtual R&D Day scheduled for December 15, 2022, at 8:30 am ET, which will be webcast on the company's website. A replay will be available within 48 hours post-event. Alnylam, a leader in RNA interference therapeutics, aims to transform treatments for rare and common diseases. The company has developed several commercial products and has a robust pipeline of investigational medicines. To learn more, visit www.alnylam.com.