Alnylam Pharmaceuticals Inc Stock Price, News & Analysis

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.

Alnylam Pharmaceuticals (Nasdaq: ALNY) has submitted a supplemental New Drug Application (sNDA) to the FDA for vutrisiran, an investigational RNAi therapeutic for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM). The submission is based on positive results from the HELIOS-B Phase 3 study, which demonstrated favorable effects on outcomes of death and cardiovascular events, functional capacity, and quality of life in ATTR-CM patients.

Alnylam utilized a Priority Review Voucher to accelerate the FDA review timeline. Vutrisiran, currently approved as AMVUTTRA® for treating polyneuropathy of hereditary ATTR amyloidosis in adults, showed a safety profile consistent with its established profile in the HELIOS-B study. The company believes vutrisiran has the potential to become a first-line therapy for ATTR-CM, pending regulatory approval.

Alnylam Pharmaceuticals (Nasdaq: ALNY) presented new data from the HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy (ATTR-CM) at the HFSA Annual Scientific Meeting 2024. The data showed that vutrisiran significantly improved echocardiographic assessments of cardiac structure, systolic function, and diastolic function compared to placebo over 30 months. Vutrisiran also demonstrated relative stability of cardiac biomarkers NT-proBNP and Troponin-I.

Key findings include:

• Improvements in cardiac wall structure, diastolic function, and systolic function
• 32% relative reduction in NT-proBNP and troponin I in the overall population
• Larger treatment effects observed in the monotherapy population

Alnylam plans to complete multiple global regulatory submissions for vutrisiran in ATTR-CM by the end of the year.

Alnylam Pharmaceuticals (Nasdaq: ALNY) has announced plans to webcast its TTR Investor Day event on October 9, 2024, at 8:30 am ET. The event will be accessible through the Investors section of the company's website, with a replay available within 48 hours.

The TTR Investor Day will feature presentations from Alnylam's management team, including senior commercial leaders who will discuss launch preparation and market leadership potential in ATTR amyloidosis with cardiomyopathy (ATTR-CM). Dr. Ahmad Masri, Associate Professor of Medicine at Oregon Health & Science University, will join as a leading expert in ATTR amyloidosis to share insights on clinical management of ATTR-CM and unmet medical needs.

Alnylam Pharmaceuticals (ALNY) announced positive results from the HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy (ATTR-CM). The study met all primary and secondary endpoints, showing significant benefits in reducing mortality and cardiovascular events.

Key findings include:

• 28% reduction in primary composite of all-cause mortality and recurrent cardiovascular events in the overall population
• 36% reduction in all-cause mortality up to 42 months in the overall population
• 33% reduction in primary composite endpoint in the monotherapy population
• Significant improvements in disease progression measures and cardiac biomarkers

Vutrisiran demonstrated an encouraging safety profile consistent with previous studies. Alnylam plans to submit regulatory filings globally, starting later this year.

Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has announced its participation in two major investor conferences in September 2024. The company will present overviews at the Wells Fargo 2024 Healthcare Conference in Boston on September 4 at 9:30 am ET, and the Morgan Stanley 22nd Annual Global Healthcare Conference in New York City on the same day at 1:05 pm ET.

Investors and interested parties can access live audio webcasts of both presentations through the Investors section of Alnylam's website at www.alnylam.com/events. Replays will be made available within 48 hours after each event, allowing those unable to attend live to catch up on the company's latest updates and strategies.

Alnylam Pharmaceuticals (Nasdaq: ALNY) will present detailed results from the HELIOS-B Phase 3 study of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy at the European Society of Cardiology (ESC) Congress 2024. The study met its primary endpoint, showing a significant reduction in all-cause mortality and recurrent cardiovascular events. Vutrisiran also demonstrated an acceptable safety profile.

The company will host an Investor Webcast on August 30, 2024, to discuss the results. Additionally, Alnylam will present findings from the KARDIA-2 Phase 2 study of zilebesiran for hypertension and new data from post-hoc analyses of the APOLLO-B Phase 3 and APOLLO-OLE studies of patisiran in ATTR amyloidosis with cardiomyopathy patients.

Alnylam Pharmaceuticals (ALNY) reported strong Q2 2024 results, with global net product revenues of $410 million, up 34% year-over-year. The growth was driven by the TTR business, which grew 37% annually. The company announced positive topline results from the HELIOS-B Phase 3 study of vutrisiran for ATTR cardiomyopathy, showing significant improvements in cardiovascular outcomes and mortality. Alnylam updated its 2024 financial guidance, increasing combined net product revenue guidance to $1,575-$1,650 million. The company achieved a GAAP operating income of $48.6 million and a non-GAAP operating income of $137.9 million for Q2 2024. Alnylam ended the quarter with $2.62 billion in cash and investments.

Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has announced its plan to report second quarter 2024 financial results on Thursday, August 1, 2024, before U.S. markets open. The company will host a conference call at 8:30 am ET on the same day, where management will provide a company update and discuss Q2 2024 results along with future expectations.

Investors can access a live audio webcast of the call on Alnylam's website in the Investors section. An archived version of the webcast will be available approximately two hours after the event.