Alnylam Pharmaceuticals

Alnylam Pharmaceuticals, Inc. is a global commercial-stage biopharmaceutical company, which engages in the discovery, development and commercialization of RNAi therapeutics. Its products include ONPATTRO, GIVLAARI, and OXLUMO. The company was founded by Noble Laureate, David Bartel, Thomas Tuschl, Phillip Zamore, Paul R. Schimmel, and Phillip A. Sharp on June 14, 2002 and is headquartered in Cambridge, MA.

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Alnylam Pharmaceuticals reports robust 2022 performance and growth opportunities

Alnylam Pharmaceuticals had a strong financial performance in 2022, driven by the success of AMVUTTRA and advancements in ATTR amyloidosis treatments.
While facing challenges such as FDA requests and the need for self-sustainability, the company is poised for growth with projected revenues and pipeline opportunities.
Opportunities lie in market expansion, innovative pipeline programs, and upcoming regulatory milestones, positioning Alnylam for continued success in RNAi therapeutics.

Alnylam Pharmaceuticals posts robust Q1 growth despite FDA challenges

Alnylam Pharmaceuticals reported strong financial performance in Q1 2023, driven by the TTR franchise and key product sales growth. Despite challenges with the FDA's partial clinical hold, the company remains optimistic about pipeline development and addressing unmet patient needs with RNAi therapeutics.

Alnylam Pharmaceuticals excels in Q2, poised for growth and innovation

Alnylam Pharmaceuticals delivered strong financial results, positive clinical data, and strategic partnerships in Q2 2023, positioning itself for continued growth.
While facing challenges such as market competition and regulatory complexities, Alnylam remains focused on innovation, patient care, and commercial success.
The company's emphasis on R&D, market positioning, and leveraging its RNAi platform underscores its commitment to advancing therapies and driving value for stakeholders.

Alnylam Pharmaceuticals reports robust Q3 growth and eyes HELIOS-B opportunities

Alnylam Pharmaceuticals delivered strong financial results in Q3 2023, showcasing growth and innovation in its product portfolio and pipeline. Despite challenges, the company remains focused on long-term strategies and seizing opportunities in the evolving healthcare landscape.

Alnylam Pharmaceuticals excels in 2023, poised for market leadership

Alnylam Pharmaceuticals demonstrated strong financial performance in 2023, with notable achievements in commercial RNAi therapeutics and franchise growth. The company's strategic focus on innovation, study optimization, and market positioning bodes well for future success and market leadership in RNAi therapeutics.

Alnylam Pharmaceuticals reports robust Q1 performance and strategic readiness

Alnylam Pharmaceuticals showcased strong financial performance, strategic focus on patient needs, and readiness for upcoming milestones.
While facing challenges in meeting guidance and ensuring successful launches, the company is well-positioned for growth and innovation.
Opportunities lie in upcoming milestones, secondary endpoint focus, and future catalysts, driving potential value creation and differentiation.

Alnylam Pharmaceuticals excels in Q2 2024, poised for sustained growth

Alnylam Pharmaceuticals demonstrated strong financial performance and clinical advancements in Q2 2024, driven by key revenue growth drivers and pipeline progress.
While facing challenges such as rising expenses, the company's strategic strengths in franchise performance and margin improvement position it well for future opportunities.
With upcoming milestones and increased guidance, Alnylam is poised to capitalize on growth prospects and maintain its position as a leader in rare disease therapeutics.

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Alnylam Pharmaceuticals, Inc. is a biopharmaceutical company. It engages in the business of developing and commercializing novel therapeutics based on ribonucleic acid interference. The company was founded by Noble Laureate, David Bartel, Thomas Tuschl, Phillip Zamore, Paul R. Schimmel, and Phillip Allen Sharp on June 14, 2002 and is headquartered in Cambridge, MA.

Alnylam (ALNY) reports better-than-expected third-quarter 2023 results, beating both earnings and sales estimates on the back of higher collaboration revenues.

Alnylam (ALNY) Swings to Earnings in Q3 on Collaboration Revenues

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY ) Q3 2023 Earnings Conference Call November 2, 2023 8:30 AM ET Company Participants Christine Lindenboom - Senior Vice President-Investor Relations and Corporate Communication Yvonne Greenstreet - Chief Executive Officer Tolga Tanguler - Chief Commercial Officer Pushkal Garg - Chief Medical Officer and EVP, Development & Medical Affairs Jeff Poulton - Chief Financial Officer Conference Call Participants Ritu Baral - TD Cowen Paul Matteis - Stifel Lisa Munro - RBC Ellie Merle - UBS David Lebowitz - Citi Maury Raycroft - Jefferies Gena Wang - Barclays Mike Ulz - Morgan Stanley Operator Good day and thank you for standing by. Welcome to the Alnylam Pharmaceuticals Q3 2023 Earnings Conference Call.

Alnylam Pharmaceuticals, Inc. (ALNY) Q3 2023 Earnings Call Transcript

While the top- and bottom-line numbers for Alnylam (ALNY) give a sense of how the business performed in the quarter ended September 2023, it could be worth looking at how some of its key metrics compare to Wall Street estimates and year-ago values.

Alnylam (ALNY) Q3 Earnings: Taking a Look at Key Metrics Versus Estimates

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2023 and reviewed recent business highlights. “We continued to deliver strong commercial results in the third quarter, with the successful launch of AMVUTTRA contributing to 35% year-over-year growth in net product revenues,” said Yvonne Greenstreet, MBChB, Chief Executive Officer of Al.

Alnylam Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Period Activity

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced its third place ranking in Science magazine's Top Employer Survey for 2023. This marks the fifth year that Alnylam was featured as one of the top three companies in the annual survey of more than 6,800 professionals across biotechnology, biopharmaceuticals, and related industries. “As a science-based organization, it's critically important to us that Alnylam be regar.

Alnylam Recognized by Science Magazine as Top Employer for Fifth Consecutive Year

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that results from the APOLLO-B Phase 3 study of investigational patisiran in patients with the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis were published online in the New England Journal of Medicine (NEJM). The data reported in the APOLLO-B Phase 3 study publication demonstrate that patisiran, an RNAi therapeutic targeting transthyretin (TTR),.

Alnylam Announces Publication of Results from APOLLO-B Phase 3 Study of Patisiran in Patients with the Cardiomyopathy of ATTR Amyloidosis in the New England Journal of Medicine

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced additional positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer's disease and cerebral amyloid angiopathy (CAA). The data were presented today in a late-breaker session at the 16th Clinical Trials on Alzheimer's Disease (CTAD) c.

Alnylam Reports Additional Positive Interim Phase 1 Results for ALN-APP, in Development for Alzheimer's Disease and Cerebral Amyloid Angiopathy

Alnylam (ALNY) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Alnylam Pharmaceuticals (ALNY) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the third quarter ending September 30, 2023 on Thursday, November 2, 2023, before the U.S. financial markets open. Management will provide an update on the Company and discuss third quarter 2023 results as well as expectations for the future via conference call on Thursday, November 2, 2023 at 8:30 am ET. To access the.

Alnylam to Webcast Conference Call Discussing Third Quarter 2023 Financial Results

We rate Alnylam Pharmaceuticals, Inc.'s common stock a Buy on the dip after the complete response letter, CRL for Patisiran. The investment thesis is based on the high probability of success for Vutrisiran, the company's next-generation inverse RNA or RNAi candidate, in treating cardiac amyloidosis in the upcoming Phase 3. My price target for Alnylam Pharmaceuticals, Inc. common stock is $300, representing a 76% upside based on the discounted cash flow valuation method.

Alnylam Pharmaceuticals: A Good Buy Ahead Of Phase 3 Data For Vutrisiran

Despite a positive panel recommendation, the FDA rejected the Alnylam Pharmaceuticals, Inc. application to market Onpattro for ATTR-CM, citing a lack of meaningful evidence of clinical efficacy. Amvuttra has always been the bigger opportunity in ATTR-CM, and now investors await the pivotal HELIOS-B clinical data in early 2024. Despite a good track record of drug development, ATTR-CM has been a tough target for Alnylam, and past failures (revusiran and Onpattro) are likely to drive elevated skepticism for HELIOS-B.

Alnylam: FDA Rejection Of Onpattro For ATTR-CM Is A Setback, But A Manageable One

Alnylam's stock declined after the FDA issued a complete response letter citing inadequate evidence to support the efficacy of Onpattro in treating ATTR amyloidosis patients with cardiomyopathy. This is a minor setback because the HELIOS-B trial of Amvuttra holds the key to Alnylam's TTR franchise in this patient population. The HELIOS-B trial will be critical for the stock's medium-term performance.

Alnylam: Why The FDA Rejection Of Onpattro Is A Minor Setback

Alnylam's (ALNY) label expansion-seeking application for Onpattro, to treat transthyretin-mediated amyloidosis with cardiomyopathy, gets the FDA's CRL on the grounds of insufficient data. The stock falls 5%.

Alnylam (ALNY) Receives CRL for the Label Expansion of Onpattro

Drugmaker Alnylam wanted to expand approval of its drug Onpattro, but the Food and Drug Administration rejected the application even after an outside advisory committee voted in favor of it.

Alnylam Stock Is Dropping on Surprising FDA Rejection

Alnylam stock skidded Monday after the FDA rejected its drug, Onpattro, as a treatment for patients with a heart disease.

Alnylam Stock Crumbles After The FDA Unexpectedly Rejects Its Heart Drug

The U.S. Food and Drug Administration has declined to approve the expanded use of Alnylam Pharmaceuticals' drug to treat a rare and fatal heart disease, citing insufficient evidence of clinical meaningfulness, the company said on Monday.

US FDA declines approval for expanded use of Alnylam's heart-disease drug

Alnylam Pharmaceuticals Inc. ALNY, -1.00% said Monday it would no longer pursue its supplemental new drug application (sNDA) for patisiran as a treatment for the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis after receiving a complete response letter from the U.S. Food and Drug Administration. Patisiran is already approved for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

Alnylam to scrap sNDA for patisiran after receiving FDA complete response letter

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. Patisiran is the established name for ONPATTRO®, which is approved by the FDA for the treatment of t.

Alnylam Announces Receipt of Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

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Upcoming announcements from the U.S. Food and Drug Administration could cause several biotech stocks to rocket higher. Alnylam is expecting a decision regarding a progressive heart condition that could lead to billions in additional annual sales.

2 Growth Stocks That Could Rocket Higher Before the End of 2023

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company will present new results for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis, at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2023, October 6-9, 2023. Data from an interim analysis of the ongoing open-label extension.

Alnylam to Present Additional Data for Patisiran in Patients With the Cardiomyopathy of ATTR Amyloidosis, Including 24-Month Results From the APOLLO-B Phase 3 Study, at the Heart Failure Society of America Annual Scientific Meeting 2023

Alnylam (ALNY) receives a positive opinion from the FDA's advisory committee regarding the label expansion of patisiran to treat the cardiomyopathy of transthyretin-mediated amyloidosis.

Alnylam's (ALNY) Onpattro sNDA Gets FDA Advisory Committee Nod

Alnylam stock tumbled Thursday after a split advisory panel recommended the Food and Drug Administration approve its heart disease treatment.

Alnylam Pharma Tumbles After FDA Advisors Dash Its Hopes Of Rivaling Pfizer

Alnylam Pharmaceuticals Inc. ALNY, +3.89% shares fell more than 8% premarket on Thursday after advisers to the U.S. Food and Drug Administration on Wednesday weighed the risks and benefits of the company's treatment for a serious heart condition known as ATTR-CM. The FDA advisory committee voted 9 to 3 that the benefits of the treatment, Onpattro, outweigh its risks in patients with ATTR-CM, but the committee's comments suggest that the drug's label may be limited, analysts say.

Alnylam Pharmaceuticals shares fall after FDA advisers weigh in on heart-disease drug

An outside panel of experts to the U.S. Food and Drug Administration on Wednesday backed the expanded use of Alnylam Pharmaceuticals' gene silencing drug to treat a type of heart disease associated with a rare organ-damaging disorder.

U.S. FDA panel backs expanded use of Alnylam's gene silencing drug

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the positive outcome of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting to discuss the supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. The CRDAC voted 9:3.

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