ALNY - Why Is Genetic Disease-Focused Alnylam Pharmaceuticals Stock Trading Lower Today? | Benzinga
The FDA has issued a Complete Response Letter (CRL) to Alnylam Pharmaceuticals Inc's (NASDAQ: ALNY) supplemental New Drug Application (sNDA) for patisiran for cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.
Patisiran, under Onpattro, is approved by the FDA for polyneuropathy of hereditary ATTR amyloidosis in adults.
In September, the FDA advisory committee voted 9-3 in favor of Alnylam's patisiran. However, the FDA questioned the drug's efficacy in a briefing document.
For ...