IONIS PHARMACEUTICALS, INC. (NASDAQ:IONS) Files An 8-K Other EventsItem 8.01. Other Events.
On August 27, 2018, Ionis Pharmaceuticals, Inc. (the “Company”) announced that the Company’s affiliate, Akcea Therapeutics, Inc., received a Complete Response Letter from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration regarding the New Drug Application for WAYLIVRA™ (volanesorsen). A copy of the press release is attached to this Report as Exhibit 99.1 and is incorporated by reference into this Item 8.01.
Item 9.01. Financial Statements and Exhibits.
Press Release, dated August 27, 2018, issued by the Company
IONIS PHARMACEUTICALS INC ExhibitEX-99.1 2 ex99_1.htm EXHIBIT 99.1 Exhibit 99.1 Akcea and Ionis Receive Complete Response Letter for WAYLIVRA from FDA CAMBRIDGE,…To view the full exhibit click
About IONIS PHARMACEUTICALS, INC. (NASDAQ:IONS)
Ionis Pharmaceuticals, Inc., formerly Isis Pharmaceuticals, Inc., is engaged in discovering and developing ribonucleic acid-targeted (RNA-targeted) therapeutics. The Company operates through two segments: Ionis Core and Akcea Therapeutics. The Company’s Ionis Core segment is developing a drug discovery platform. The Company’s Akcea Therapeutics segment consists of the operations of its subsidiary, Akcea Therapeutics, Inc., which develops and commercializes drugs for cardiometabolic disorders. The Company is developing transformational drugs, which include nusinersen, IONIS-TTR and volanesorsen that are designed to treat patients with orphan diseases. In addition to its Phase III programs, the Company has a pipeline of drugs in Phase II development, which includes IONIS-FXI and IONIS-APO(a)-L. Its Phase II pipeline includes drugs to treat patients with severe and rare diseases, viral infections, ocular diseases, metabolic disorders and cardiovascular diseases.