Alnylam Pharmaceuticals, Inc. (ALNY) Overstated the Efficacy of its Onpattro Lipid Complex Injection

According to the complaint, the U.S. Food and Drug Administration ("FDA") approved patisiran for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults in August 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 patisiran lipid complex injection, and notes "concerns over cardiac deaths in patients treated with ONPATTRO" suggesting a "limited market opportunity in TTRcardiomyopathy, and a potential platform safety risk." On this news, Alnylam's stock fell $5.60 per share to close at $94.75 on September 12, 2018.

Then, on September 27, 2018, Alnylam announced an issue with another drug – givosiran – which reported 22% of its patients suffered serious side effects compared to 10% of patients on placebo. Alnylam's stock fell even further on this news, and continues to trade below its pre-disclosure price.

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