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Wave Life Sciences Reports Third Quarter 2019 Financial Results and Provides Business Update
Fast Track designation for suvodirsen received from the U.S. FDA
Interim analysis of dystrophin expression from suvodirsen open-label extension study expected in 4Q 2019
Topline data from PRECISION-HD2 clinical trial expected by year-end
Key hires and board expansion mark continued progress towards commercial preparedness in the U.S.
CAMBRIDGE, Mass., November 5, 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 third quarter ended September 30, 2019 and provided a business update.
We continued our strong execution in the third quarter and, as a result, we are on track to deliver key clinical data readouts in the fourth quarter from our open-label extension study of suvodirsen in Duchenne muscular dystrophy and from PRECISION-HD2, the first of our two Phase 1b/2a trials in Huntingtons disease, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. In anticipation of our potential launch of suvodirsen in the United States and future late-stage programs, we hired a Chief Commercial Officer with proven experience in neurology and rare disease and named three new Board members with deep expertise in clinical development, product commercialization and government and payor relations.
As we prepare for our near-term milestones, we continue to advance our platform, PRISM, with new preclinical programs such as our SNP3 program in Huntingtons disease and our lead ophthalmology program for Usher Syndrome Type 2A, continued Dr. Bolno. In addition, were very excited about the latest modality to emerge from PRISM, ADAR-mediated RNA editing, which we presented during our Analyst and Investor Research Day in early October.
Wave is committed to building a fully integrated genetic medicines company led by its clinical and preclinical programs for the treatment of neuromuscular, central nervous system and ophthalmologic diseases.
Suvodirsen in patients with Duchenne muscular dystrophy amenable to exon 51 skipping
Suvodirsen, an investigational compound, is currently being studied in an open-label extension (OLE) study and a Phase 2/3 study (as described below) in patients with Duchenne muscular dystrophy (DMD) with mutations amenable to exon 51 skipping. Wave is on track to deliver an interim analysis of dystrophin expression from muscle biopsies in boys receiving suvodirsen, which is expected in the fourth quarter of 2019. This interim analysis will include dystrophin expression from muscle biopsies taken 22 weeks after patients enrolled in the
The following information was filed by Wave Life Sciences Ltd. (WVE) on Tuesday, November 5, 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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