Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for L...
Alnylam Pharmaceuticals, Inc. (ALNY)
Last alnylam pharmaceuticals, inc. earnings: 2/6 08:00 am
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Source: Business Wire
- Lumasiran is the First Potential Therapeutic to Demonstrate Substantial Reduction in Urinary Oxalate Excretion – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). PH1 is an ultra-rare, life-threatening disease impacting the kidneys and other vital organs; it affects infants, children, and adults.In the U.S., lumasiran has previously received Pediatric Rare Disease Designation, Orphan Drug Designation, and Breakthrough Therapy Designation for the treatment of PH1, based on data showing a substantial reduction in urinary oxalate, the key toxic metabolite responsible for the clinical manifestations of the disease.The Company
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ALNY
Earnings
- 10/30/25 - Beat
ALNY
Sec Filings
- 12/3/25 - Form 8-K
- 12/1/25 - Form 4
- 11/19/25 - Form 4
- ALNY's page on the SEC website