Prosensa Holding N.V. (NASDAQ: RNA) reported Q3 EPS of (€0.29), versus (€0.12) reported last year.

Recent Corporate Highlights

Drisapersen Development Program

• On September 17, we announced that a staged program of re-dosing had commenced, with the first patients re-dosed in the United States. The re-dosing program in North America will include up to 72 patients across 14 sites who had participated in the drisapersen DEMAND V (Phase II) & DEMAND III (Phase III) studies.
• On September 26, we announced that we had extended our re-dosing program of drisapersen in patients with DMD into Europe, starting with Belgium.
• On October 10, we announced that we submitted the first module for an NDA regulatory filing for drisapersen to the FDA for treating DMD. Drisapersen was granted "Fast Track status" and "Breakthrough Therapy designation" from the FDA, making it eligible for a rolling review of the NDA.

Publications & Scientific Presentations

• On September 8, we announced that results from an exploratory, double-blind, placebo-controlled Phase II study (DEMAND II/DMD114117) of drisapersen in patients with DMD were published in The Lancet Neurology. The publication of the results of the study, which investigated the efficacy and safety of drisapersen over 48 weeks, describes the positive outcome of this study, meeting its primary endpoint, without any reported major safety concerns. Top-line study results were first presented in April 2013.
• On September 24, the results of our research into developing an accurate and reproducible method for the measurement of dystrophin in patients with DMD and Becker's muscular dystrophy (BMD) were published in the online peer-reviewed journal PLOS ONE. The publication, by Chantal Beekman et al from Prosensa, describes the Company's semi-automated image analysis method, which was shown to be objective (operator independent), reproducible (in multiple samples and experiments) and sensitive for assessing dystrophin levels by immunofluorescence in muscle biopsies from BMD and DMD patients in natural history studies or clinical studies with compounds aiming to restore dystrophin expression.
• On October 7-11, during the 19^th International Congress of the World Muscle Society (WMS) in Berlin, Germany, we and our collaborators presented 12 abstracts, including abstracts discussing biomarkers to measure disease progression, clinical results and our pre-clinical work on multi-exon skipping, which could address the rarer mutations (region 10-40) in the dystrophin gene.

For earnings history and earnings-related data on Prosensa Holding N.V. (RNA) click here.