Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
A class action has been commenced in the United States District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) securities between February 15, 2018 and September 12, 2018, (the “Class Period”).
According to the complaint, Alnylam is a global biopharmaceutical company developing therapeutics based on RNA interference (“RNAi”). RNAi is a naturally occurring biological pathway within cells for sequence-specific silencing and regulation of gene expression. In December 2017, Alnylam submitted its first new drug application and marketing authorization application for Onpattro (patisiran) to the U.S. Food and Drug Administration (“FDA”). Patisiran is an intravenously administered RNAi therapeutic targeting transthyretin (“TTR”) for the treatment of hereditary ATTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of TTR protein before it is made.
The complaint alleges that, on September 12, 2018, Nomura/Instinet analyst Christopher Marai stated that a review document released by the FDA’s Center for Drug Evaluation and Research “highlights greater risk” with respect to certain trials of Alnylam’s ONPATTRO (patisiran) lipid complex injection, as well as “a limited market opportunity in TTR cardiomyopathy, and a potential platform safety risk.” Specifically, Mr. Marai asserted that “[t]he document highlights FDA reviewers’ concerns over cardiac deaths in patients treated with ONPATTRO and suggests that the drug should be limited to patients with polyneuropathy only (i.e., not patients with cardiac manifestations and polyneuropathy). Furthermore, we believe some comments on the lack of cardiac efficacy call into question claims made by [Alnylam] in this regard.”
Following this news, Alnylam’s stock price fell $5.60, or over 5.5%, to close at $94.75 per share on September 12, 2018.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (i) Alnylam overstated the efficacy and safety of its Onpattro (patisiran) lipid complex injection; and (ii) as a result, Alnylam’s public statements were materially false and misleading at all relevant times.
If you are a current shareholder and/or purchased stock pursuant during the period between February 15, 2018 and September 12, 2018, and would like to discuss your options of exercising your rights as a shareholder, please contact us.
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