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On September 13, 2023, Alnylam announced the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) approved Alnylam’s application to expand approval for Onpattro to ATTR-cardiomyopathy (CM) patients. Analysts commenting on the approval noted the FDA was not overly positive and “emphasized the small treatment effects and was seemingly negative on clinical meaningfulness.”
Following this news, Alnylam’s stock price fell by $18.59 per share, or approximately 4% to close at $193.06 per share.
Further, on October 9, 2023, Alnylam issued a press release announcing that the FDA issued a Complete Response Letter (CRL) as to the Company’s “supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.” Alnylam announced that the CRL indicated that “the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established, and therefore, the sNDA for patisiran could not be approved in its present form.” As a result, the Company announced it would no longer pursue an expanded indication for patisiran in the U.S.
Following this news, Alnylam’s stock price fell by $2.53 per share, or approximately 2% to close at $165.29 per share.