Plaintiff's law firm issued a press release on September 26, 2018, announcing the lawsuit. According to the press release, Alnylam Pharmaceuticals, Inc. (“Alnylam” or the “Company”) 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 harness the RNAi pathway to develop a potential new class of innovative medicines, known as RNAi therapeutics. RNAi therapeutics are comprised of small interfering RNA, or siRNA, and function upstream of today’s medicines by potently silencing messenger RNA, or mRNA, that encode for disease-causing proteins, thus preventing them from being made.
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.
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.
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.