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Alnylam Pharmaceuticals Inc.

http://www.alnylam.com

Latest From Alnylam Pharmaceuticals Inc.

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In a wilderness period for biotech stocks, platform company revenues may offer investors less volatile biotech exposure. They are unlikely to shepherd an exit from the current doldrums, though.

Stock Watch Platform Technologies

US FDA’s October Outlook: Xphozah After Dispute, Santhera’s New Steroid For DMD, & Plenty Of Pfizer

Fourteen user fee goal dates are on the October calendar, including three novel agents, according to the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Alnylam Onpattro’s Expanded Use Gets Weak Thumbs Up From US FDA Panel

A restrictive label could be the result of the lukewarm endorsement from the majority of the agency’s Cardiovascular and Renal Drugs Advisory Committee for use of Onpattro for the treatment of ATTR-associated cardiomyopathy.

Advisory Committees Clinical Trials

Alnylam's Onpattro: Not Following FDA Guidance Amplifies Clinical Meaningfulness Concerns

Even if Alnylam can get a favorable advisory committee vote and is able sneak out an approval for Onpattro for ATTR-associated cardiomyopathy, its lack of data on hard clinical outcomes makes it unlikely to unseat Pfizer’s tafamidis for the rare disease.

United States Advisory Committees
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
  • Biotechnology
    • Antisense, Oligonucleotides
    • Large Molecule
    • Synthesis Technologies, Production Processes
  • Other Names / Subsidiaries
    • Regulus Therapeutics, Inc.
    • Sirna Therapeutics, Inc. Alnylam U.S., Inc Ribopharma AG
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