NEW YORK, Oct. 17, 2023 (GLOBE NEWSWIRE) — Levi & Korsinsky notifies investors that it has commenced an investigation of Alnylam Pharmaceuticals, Inc. (“Alnylam” or the “Company”) (NASDAQ: ALNY) concerning possible violations of federal securities laws.
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.
To obtain additional information, go to:
or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500.
WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
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New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
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