Spark Therapeutics (ONCE) Misses Q2 EPS by 7c

Spark Therapeutics (NASDAQ: ONCE) reported Q2 EPS of ($1.04), $0.07 worse than the analyst estimate of ($0.97). Revenue for the quarter came in at $1.29 million versus the consensus estimate of $1.17 million.

“During the last several months, we have made significant progress advancing our clinical portfolio of AAV gene therapy candidates and showcasing the strengths of our overall platform capabilities,” said Jeffrey D. Marrazzo, chief executive officer of Spark. “Notably, we released additional positive data from the continuation of the Phase 3 trial of voretigene neparvovec and remarkable, preliminary safety and efficacy data from the Phase 1/2 clinical trial of SPK-9001 in hemophilia B, which also was granted breakthrough therapy designation.”

“We also continued to make significant progress in preparing the potentially first-ever BLA submission of a gene therapy for a genetic disease, and we are on track to submit the clinical modules and finalize the vast majority of the chemistry, manufacturing and controls (CMC) components before the end of the year,” continued Mr. Marrazzo. “However, based on a recent reassessment of the timelines for completion of the CMC modules, we now expect the generation of certain data using validated quality control methods that are part of the CMC modules to occur in early 2017.”

“We closed the quarter with a healthy balance sheet and we remain focused on finalizing our regulatory submissions of voretigene neparvovec, initiating a clinical trial of SPK-8011 for hemophilia A and further scaling-up of our manufacturing process for future applications.”

For earnings history and earnings-related data on Spark Therapeutics (ONCE) click here.

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