Alnylam Pharmaceuticals Inc.
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Latest From Alnylam Pharmaceuticals Inc.
Stock Watch: The Rise Of Biotech Platforms
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.
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.
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.
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.
Company Information
- Industry
-
Pharmaceuticals
- Drug Delivery
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Biotechnology
- Antisense, Oligonucleotides
- Large Molecule
- Synthesis Technologies, Production Processes
- Other Names / Subsidiaries
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- Regulus Therapeutics, Inc.
- Sirna Therapeutics, Inc. Alnylam U.S., Inc Ribopharma AG
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