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Alnylam Pharmaceuticals has secured FDA approval for Amvuttra in ATTR-CM, opening the door to potential revenue of over $6B. The company's strong R&D pipeline, including promising candidates like zilebesiran, supports long-term growth and will reduce its heavy near-term reliance on the TTR franchise. Amvuttra is likely to see strong initial adoption in ATTR-CM patients who've progressed on stabilizers, but greater first-line use and switchovers could drive the upside.
ALNY secures FDA approval for an sNDA in the United States, seeking the label expansion of Amvuttra to treat ATTR amyloidosis with cardiomyopathy.
The U.S. Food and Drug Administration on Thursday approved Alnylam Pharmaceuticals Inc.'s ALNY supplemental application for Amvuttra (vutrisiran) in adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis, or ATTR-CM, to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits.
Alnylam Pharmaceuticals' shares rose about 7% before the bell on Friday following U.S. approval for its drug for a rare and deadly heart disease, securing an entry into a market dominated by Pfizer's blockbuster Vyndaqel.
U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the entry of a new type of medicine in a market dominated by Pfizer's blockbuster Vyndaqel.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failu.
ALNY stock soars 62% in a year, driven by increasing Amvuttra and Givlaari sales. Its ongoing collaboration deals with RHHBY, NVS and REGN are progressing well.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the Stifel 2025 Virtual CNS Forum on Tuesday, March 18, 2025 at 3:00 pm ET. A live audio webcast of the presentation will be available on the Investors section of the Company's website, www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event. About Alnylam Pharm.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the retirement of Dr. Phillip A. Sharp, Ph.D., from the Company's Board of Directors, effective as of May 8, 2025. Dr. Sharp has served as a key advisor to Alnylam since he co-founded the Company in 2002. Dr. Sharp will remain a member of the Alnylam Scientific Advisory Board. “Phil helped pioneer the RNAi revolution, sparking the scientific collaboration that.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, is hosting an R&D Day today in New York City and will also webcast the event. The Company plans to showcase its R&D progress and platform innovation, including updates on multiple near- and mid-stage potentially transformative therapies that represent blockbuster opportunities as its pipeline rapidly expands across multiple therapeutic areas. “Alnylam is driving the fi.