March 23, 2020 - The case was dismissed.

July 31, 2019 - A motion to dismiss the amended complaint was filed.

July 3, 2019 - An amended complaint was filed.

September 26, 2018 - An investor in shares of Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Alnylam Pharmaceuticals, Inc. in connection with certain allegedly false and misleading statements made between February 22, 2017 and July 19, 2018.

According to the complaint the plaintiff alleges on behalf of purchasers of Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) common shares between February 22, 2017 and July 19, 2018, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between February 22, 2017 and July 19, 2018, the defendants made false and/or misleading statements and/or failed to disclose that Alnylam overstated the efficacy and safety of its Onpattro (patisiran) lipid complex injection, and that as a result, Alnylam’s public statements were materially false and misleading at all relevant times.

Cambrdige, MA based Alnylam Pharmaceuticals, Inc. is a biopharmaceutical company that is engaged in the discovery, development and commercialization of ribonucleic acid (RNA) interference (RNAi) therapeutics. Alnylam Pharmaceuticals, Inc. reported that its annual Total Revenue rose from $47.16 million in 2016 to $89.91 million in 2017 and that its Net loss increased from $410.11 million in 2016 to $490.87 million in 2017.

On September 7, 2017, Alnylam Pharmaceuticals, Inc. advised investors that the Company had stop giving doses of fitusiran, Alnylam's experimental hemophilia treatment, to patients enrolled in the Company's clinical studies, following the death of a patient who developed a blood clot.

In December 2017, Alnylam Pharmaceuticals, Inc. 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.
In August 2018, patisiran received FDA approval for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, having been reviewed by the FDA under Priority Review and previously granted Breakthrough Therapy and Orphan Drug Designations.

On September 12, 2018, Nomura/Instinet analyst Christopher Marai stated that a review document released by the U.S. Food and Drug Administration's ( FDA ) Center for Drug Evaluation and Research highlights greater risk with respect to certain trials of Alnylams' ONPATTRO (patisiran) lipid complex injection, 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.