pharmaphorum4d
Alnylam hails vutrisiran data, but investors seem sceptical
Alnylam Pharma has been riding high since revealing top-line results from its HELIOS-B trial of vutrisiran in transthyretin-mediated amyloidosis (ATTR) – but a look at the full data seems to ...
Monthly Prescribing Reference7d
Vutrisiran Under Review for Transthyretin Amyloid Cardiomyopathy
Vutrisiran, a transthyretin-directed small interfering RNA therapeutic, is currently approved under the brand name Amvuttra ® for the treatment of polyneuropathy manifestations of hereditary ...
BioSpace7d
Days After BridgeBio Approval, FDA Agrees to Review Alnylam’s Amvuttra in ATTR-CM
The FDA has accepted Alnylam’s supplemental New Drug Application for Amvuttra on the heels of BridgeBio’s Attruby nod, ...
Hosted on MSN6d
FDA Begins Review of Alnylam's sNDA for Expanded Amvuttra Use
Alnylam Pharmaceuticals ALNY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...
FDA accepts Alnylam’s sNDA for vutrisiran for ATTR-CM treatment
Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental ...
Zacks.com on MSN6d
BridgeBio Stock Up on FDA Approval of Cardiovascular Drug
BridgeBio Pharma, Inc. BBIO recently announced that it obtained FDA approval for its pipeline candidate acoramidis for the ...
Business Insider14d
Alnylam’s Balanced Prospects: Hold Rating Amid Promising Nucresiran Data and Strategic Focus on Vutrisiran
Despite these encouraging results, the focus remains on the launch of vutrisiran, expected in early 2025, indicating that the market potential for nucresiran is still dependent on further clinical ...
pharmaphorum1d
Alnylam’s vutrisiran aces ATTR cardiomyopathy readout
Alnylam is riding high today after reporting its RNAi drug vutrisiran showed across-the-board efficacy in cardiomyopathy associated with transthyretin-mediated amyloidosis (ATTR), setting up ...
Nasdaq1mon
Alnylam Submits Regulatory Application to the European Medicines Agency for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
− Type II Variation Submission Based on the Positive HELIOS-B Phase 3 Study in which Vutrisiran Significantly Reduced the Risk of Death and Cardiovascular Events Relative to Placebo – “Today ...
Morningstar1mon
Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity
Further with TTR, we continued to share data for vutrisiran in ATTR-CM, with detailed HELIOS-B results presented at the European Society of Cardiology Congress, and supportive echocardiographic ...
Business Wire1mon
Alnylam to Showcase Latest Data from TTR Franchise and Hypertension Program at American Heart Association Scientific Sessions 2024
Data presentations for the Company’s flagship TTR franchise include new findings from an analysis of the HELIOS-B Phase 3 study of vutrisiran, an RNAi therapeutic in development for the ...
Investing1mon
Alnylam files sNDA for new amyloidosis treatment
CAMBRIDGE, Mass. - Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY), a leader in RNAi therapeutics, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) ...