Alnylam Pharmaceuticals, Inc.

Company Name

Alnylam Pharmaceuticals, Inc.

Stock Symbol

ALNY

Class Period

February 15, 2018 to September 12, 2018

Motion Deadline

November 25, 2018

Court

Southern District of New York

The complaint charges Alnylam and certain of its officers with violations of the Securities Exchange Act of 1934.  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.  Alnylam purports to have harnessed the RNAi pathway, enabling it to develop a potential new class of innovative medicines known as RNAi therapeutics.

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 transthyretin-mediated amyloidosis (“hATTR 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 throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding the Company’s business and prospects, including that Alnylam had overstated the efficacy and safety of patisiran based on its randomized, double-blinded, placebo-controlled, global Phase 3 APOLLO study.  As a result of defendants’ false statements and/or omissions, Alnylam securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of close to $150 per share.

On August 10, 2018, the FDA’s Center for Drug Evaluation and Research (“CDER”) issued its review of ONPATTRO, which stated that “there was a higher percentage of cardiac deaths in the patisiran group” and that the APOLLO study “does not provide any cardiac efficacy data.”  The CDER stated that it recommended that, “if approved, the indication label should explicitly state that Onpattro is intended solely for treatment of . . . [p]olyneuropathy.”  The same day, Alnylam announced that, based on positive results from the Phase 3 APOLLO study, patisiran had received FDA approval for the treatment of the polyneuropathy of hATTR amyloidosis in adults, having been reviewed by the FDA under Priority Review and previously granted Breakthrough Therapy and Orphan Drug Designations. 

Then on September 12, 2018, Nomura/Instinet analyst Christopher Marai issued a report regarding the CDER’s August 10, 2018 review of ONPATTRO, stating that the review “highlights greater risk” with respect to certain trials of patisiran, as well as “a limited market opportunity in TTRcardiomyopathy, and a potential platform safety risk.”  Specifically, 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.”  On this news, Alnylam’s stock price fell $5.60 per share, or over 5.5%, to close at $94.75 per share.