Alnylam Pharmaceuticals Inc Stock Price, News & Analysis

Alnylam Pharmaceuticals (Nasdaq: ALNY) announced its participation in several upcoming healthcare conferences. Management will present at the Cowen 43rd Annual Health Care Conference on March 8, 2023, at 2:10 pm ET in Boston, the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023, at 1:20 pm ET virtually, the Barclays Global Healthcare Conference on March 16, 2023, at 8:00 am ET in Miami, and the Stifel 2023 CNS Days on March 29, 2023, at 9:30 am ET virtually. Live webcasts will be accessible on the Investors section of Alnylam's website, with replays available within 48 hours of each event.

Alnylam Pharmaceuticals reported a strong financial performance for Q4 and full year 2022, with global net product revenues reaching $262 million and $894 million, respectively, representing a 35% annual growth. The company submitted a supplemental New Drug Application for ONPATTRO® to treat cardiomyopathy associated with ATTR amyloidosis, which was accepted by the FDA. For 2023, Alnylam expects combined net product revenues of $1.2 billion to $1.285 billion. The company also saw increased patient uptake across its product portfolio, marking significant growth in commercial treatment of hATTR amyloidosis.

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.