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Gene therapy company needs to raise additional €10 million to sustain activities to next milestone. GenSight Biologics, a biopharma specializing in gene therapies for retinal neurodegenerative diseases, has announced the successful confirmation of the second Good Manufacturing Practice (GMP) batch of its lead product candidate LUMEVOQ. This event means the French biotech is now eligible to draw down the €4 million second tranche of a bridge financing agreed with Sofinnova Partners, Invus and UPMC Enterprises. GenSight is developing a pipeline of therapies using mitochondrial targeting sequence and optogenetics technologies to address retinal diseases and central nervous system disorders. The company is currently awaiting the review of its marketing authorization application by the European Medicines Agency for LUMEVOQ, a gene therapy targeting a rare mitochondrial disease leading to irreversible blindness. Before a product like LUMEVOQ can be approved for human use, a validation campaign must be completed, consisting of at least three successful GMP batches manufactured sequentially to demonstrate the robustness, control, consistency and reproducibility of the commercial manufacturing process. Earlier this year, following the successful completion of two batches, shares in GenSight fell dramatically after the third batch had to be terminated due to production issues at its contract development…
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