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Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) is at the forefront of RNA interference (RNAi) therapeutics, pioneering a transformative class of medicines aimed at treating and potentially curing a wide range of diseases. Founded in 2002 and based in Cambridge, MA, Alnylam has translated Nobel Prize-winning science into five commercial products: ONPATTRO (patisiran), AMVUTTRA (vutrisiran), GIVLAARI (givosiran), OXLUMO (lumasiran), and Leqvio (inclisiran), developed and commercialized in partnership with Novartis. These breakthrough therapeutics address conditions such as hATTR amyloidosis, acute hepatic porphyria, primary hyperoxaluria type 1, and hypercholesterolemia.
Alnylam is dedicated to expanding its pipeline with several investigational medicines in late-stage development, focusing on genetic medicines, cardio-metabolic diseases, hepatic infectious diseases, and CNS/ocular diseases. The company’s commitment to sustainable innovation is reflected in its robust product pipeline and strategic collaborations with industry leaders like Roche and Regeneron.
Financially, Alnylam reported robust growth in 2023 with $1.24 billion in global net product revenues, a reflection of its strong commercial execution across its therapeutic products. The company maintains a strong cash position, bolstered by upfront fees from research partnerships and milestone achievements.
Alnylam is also dedicated to corporate responsibility, with initiatives aimed at reducing greenhouse gas emissions, promoting diversity and inclusion in clinical trials, and expanding global health equity through its Alnylam Challengers program. The company’s environmental impact data is third-party verified, underscoring its commitment to transparency and sustainability.
Looking ahead, Alnylam aims to sustain its leadership in RNAi therapeutics with the anticipated release of topline results from the HELIOS-B Phase 3 study and the continued development of promising candidates like zilebesiran for hypertension and mivelsiran for Alzheimer’s disease. For more details on Alnylam’s people, science, and pipeline, visit www.alnylam.com.
Alnylam Pharmaceuticals announced preliminary fourth quarter and full year 2024 global net product revenues, reporting strong performance with total net product revenues of $1,646 million, representing 33% annual growth. The company's TTR franchise, including ONPATTRO and AMVUTTRA, generated Q4 revenues of $56 million and $287 million respectively, while GIVLAARI and OXLUMO contributed $65 million and $44 million.
For 2025, Alnylam provided combined net product revenue guidance of $2,050-$2,250 million, projecting 31% growth at the mid-point. The company expects to achieve non-GAAP operating income profitability in 2025. Key pipeline goals include FDA approval for vutrisiran in ATTR cardiomyopathy by March 23, 2025, initiating Phase 3 studies for nucresiran and zilebesiran, and advancing multiple clinical programs including mivelsiran for Alzheimer's disease.
Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference.
The event will take place on Monday, January 13, 2025, at 9:45 am PT (12:45 pm ET) at The Westin St. Francis in San Francisco. Management will present a company overview and engage in a Q&A session. During the presentation, Alnylam will discuss its unaudited fourth quarter and full year 2024 global net product revenues.
A live audio webcast of the presentation and Q&A session will be accessible on the Investors section of the Company’s website, www.alnylam.com/events. A replay will be made available on the website within 48 hours post-event.
Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has announced its upcoming presentation at the Piper Sandler 36th Annual Healthcare Conference. The company overview will be presented on December 5, 2024, at 11:00 am ET at the Lotte New York Palace Hotel in New York City. The presentation will be accessible via live audio webcast in the Investors section of Alnylam's website, with a replay available within 48 hours after the event.
Alnylam Pharmaceuticals (ALNY) announced FDA acceptance of their supplemental New Drug Application (sNDA) for vutrisiran to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). The FDA set a PDUFA date of March 23, 2025. The application is based on positive results from the HELIOS-B Phase 3 study, which showed favorable effects on cardiovascular outcomes, survival, and quality of life in ATTR-CM patients. If approved, vutrisiran would become the first treatment approved in the U.S. for both polyneuropathy manifestations of hATTR and cardiomyopathy manifestations of ATTR amyloidosis.
Alnylam Pharmaceuticals presented new Phase 1 study results for nucresiran, a next-generation RNAi therapeutic for ATTR amyloidosis treatment. A single dose of ≥300mg achieved rapid TTR knockdown of >90% by Day 15, sustained through Day 180. Peak reductions of >96% were reached by Day 29. At 300mg, TTR reduction remained >70% at Day 360. The drug showed encouraging safety profile with low inter-patient variability. The 600mg dose achieved 95.0% TTR reduction at Day 15 and 96.0% at Day 180, while the 900mg dose showed 91.7% reduction at Day 15 and 94.2% at Day 180. The data supports potential biannual or annual dosing regimens.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has announced its upcoming presentations at two major investor conferences in November 2024. The company will present at the UBS Global Healthcare Conference on November 12 at 8:45 am PT in Ranchos Palos Verdes, CA, and at the Jefferies London Healthcare Conference on November 20 at 9:30 am GMT in London.
Live audio webcasts will be accessible through the Investors section of Alnylam's website, with replays available within 48 hours after each presentation.
Alnylam Pharmaceuticals (ALNY) reported strong Q3 2024 financial results with global net product revenues of $420 million, representing 34% year-over-year growth. The growth was primarily driven by their TTR business, with AMVUTTRA generating $259 million and ONPATTRO $50 million in revenues. The company submitted regulatory applications in U.S. and EU for AMVUTTRA for ATTR-CM treatment. Cash position stood at $2.78 billion as of September 30, 2024. The company reiterated its 2024 financial guidance, expecting combined net product revenues of $1,575-$1,650 million.
Alnylam Pharmaceuticals (Nasdaq: ALNY) will present data from its ATTR amyloidosis and hypertension programs at the AHA Scientific Sessions 2024. The presentations include new analysis from the HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy, interim results from a Phase 1 study of ALN-TTRsc04, and new analysis of the KARDIA-1 Phase 2 study of zilebesiran for hypertension. The HELIOS-B study, published in The New England Journal of Medicine, achieved all 10 pre-specified primary and secondary endpoints.
Alnylam Pharmaceuticals (Nasdaq: ALNY), a leading RNAi therapeutics company, has announced that it will report its financial results for the third quarter of 2024 on Thursday, October 31, 2024, before the U.S. financial markets open. The company's management will provide an update and discuss the Q3 2024 results, along with future expectations, via a conference call at 8:30 am ET on the same day.
A live audio webcast of the call will be available on the Investors section of Alnylam's website at www.alnylam.com/events. An archived version of the webcast will be accessible approximately two hours after the event.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has submitted a Type II Variation to the European Medicines Agency (EMA) for vutrisiran, an investigational RNAi therapeutic for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM). This submission is based on positive results from the HELIOS-B Phase 3 study, which met all 10 primary and secondary endpoints with statistical significance.
The study demonstrated vutrisiran's effects on reducing mortality and cardiovascular events, as well as improving functional capacity, quality of life, and heart failure symptoms in ATTR-CM patients. Vutrisiran's safety profile was consistent with its established profile for hATTR amyloidosis with polyneuropathy.
Alnylam has also submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for vutrisiran in ATTR-CM treatment, with additional global regulatory submissions planned.
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