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Wave Life Sciences Reports Fourth Quarter and Full-Year 2018 Financial Results and Provides Business Update
Outlines plans for building a fully integrated genetic medicines company
CAMBRIDGE, Mass., March 1, 2019 Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases, today reported financial results for the fourth quarter and full year ended December 31, 2018 and outlined its plans for building a fully integrated company.
Our achievements throughout 2018 established a strong foundation upon which we are building a world-class and fully integrated genetic medicines company, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. For 2019, we will remain keenly focused on broadening our pipeline and preparing to launch suvodirsen for the treatment of Duchenne muscular dystrophy in boys who are amenable to exon 51 skipping. Realizing our long-term commitment to those affected by rare genetic diseases will require us to continue to advance our ongoing clinical programs, meaningfully expand into new therapeutic areas such as ophthalmology and continue to invest in and evolve our robust and innovative discovery and drug development platform.
Building a Fully Integrated Genetic Medicines Company
Wave is committed to building upon its discovery, clinical development and manufacturing capabilities and continuing its rapid transformation to become a fully integrated genetic medicines company aspiring to deliver best-in-class medicines. To achieve this ambition, the company is focused on the following priority objectives:
Urgently advancing suvodirsen (WVE-210201) toward global commercial launches, including a potential accelerated approval in the United States: Currently, suvodirsen, the companys investigational therapy for boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping, is being studied in an ongoing open-label extension (OLE) study and Wave expects to deliver an interim analysis of dystrophin expression from this study in the second half of 2019. Data from the OLE interim analysis are intended to be an important component of the companys submission to the U.S. Food and Drug Administration (FDA) for accelerated approval in the United States. Also this year, Wave anticipates initiating a global, placebo-controlled Phase 2/3 efficacy and safety clinical trial of suvodirsen. The planned Phase 2/3 trial, which is the first program to be selected for the FDA pilot program for complex innovative trial designs (CID), is designed to measure clinical efficacy and dystrophin expression, and Wave intends to use the results of this trial to seek regulatory approvals globally.
Wave also intends to make initial investments in commercial capabilities to support the companys transition to a fully integrated, commercial-stage genetic medicines company.
The following information was filed by Wave Life Sciences Ltd. (WVE) on Friday, March 1, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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