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Wave Life Sciences Reports First Quarter 2019 Financial Results and Provides Business Update
CAMBRIDGE, Mass., May 10, 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 announced financial results for the first quarter ended March 31, 2019 and provided a business update.
Since the start of the year, we have made significant progress advancing suvodirsen, our lead clinical program for the treatment of Duchenne muscular dystrophy patients amenable to exon 51 skipping, and we look forward to providing dystrophin biopsy data in the second half of the year. In parallel, initial commercialization activities are underway to support the potential approval and launch of this investigational therapy, first in the United States and then globally, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. Suvodirsen is the first of multiple development programs we intend to advance for Duchenne, potentially enabling us to reach more patients living with DMD. Beyond our Duchenne programs, we are advancing our differentiated PRECISION-HD clinical program, an allele-selective approach to treating Huntingtons disease, and we look forward to reporting topline clinical results from these HD studies by year-end.
Wave is committed to building a fully integrated genetic medicines company led by its clinical- and preclinical-stage programs for the treatment of neuromuscular, central nervous system and ophthalmologic diseases.
Initial commercialization activities ongoing following completion of suvodirsen Phase 1 clinical trial; efficacy data from ongoing open-label extension study expected this year
In April 2019, Wave announced the final results from its Phase 1 clinical trial of investigational suvodirsen (WVE-210201) in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping. The results demonstrated a favorable safety and tolerability profile of suvodirsen for continued clinical development in the ongoing open-label extension (OLE) study and planned Phase 2/3 clinical trial.
Suvodirsen is currently being studied in an OLE study, initiated in August 2018 with patients from the Phase 1 clinical trial. Wave expects to deliver an interim analysis of dystrophin expression from muscle biopsies in boys receiving suvodirsen in this study in the second half of 2019.
The company expects to file for an accelerated approval of suvodirsen in the United States in the second half of 2020, pending positive clinical dystrophin expression data.
The following information was filed by Wave Life Sciences Ltd. (WVE) on Friday, May 10, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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