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Alnylam Pharmaceuticals, Inc.

Company NameAlnylam Pharmaceuticals, Inc.
Stock SymbolALNY
Class PeriodFebruary 22, 2017 to July 19, 2018
Lead Plaintiff Motion DeadlineNovember 26, 2018

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 TTRcardiomyopathy, and a potential platform safety risk.”  Specifically, Marair 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.” 

On this news, Alnylam’s stock price fell $5.60 per share, or over 5.5%, to close at $94.75 per share on September 12, 2018.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, 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.

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