Spark Therapeutics Now Targets 2017 For US Approval Of First Retinal Gene Therapy

Two manufacturing control assays have taken longer to develop than previously thought, putting back completion of a BLA submission to early 2017 for US company Spark Therapeutics, while further progress has been made in the company’s early-stage hemophilia gene therapy program.

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Spark Therapeutics Inc. has announced a slight delay to completing the US submission of what is expected to the first BLA involving a gene therapy for a genetic disease, from the end of 2016 to early in 2017.

The company has also released clinical data on a further nine patients treated with its potential gene therapy, voretigene neparvovec...

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