GenSight Biologics S.A. - H1 results and update on GMP batch manufacturing
In addition to its H1 results last Friday, Gensight announced this morning the successful manufacturing of its 1st LUMEVOQ® GMP batch.No major surprises in this H1 update, most importantly announcing EMA feedback on LUMEVOQ®'s regulatory path forward by end of September (vs. October before) and runway until December (vs. November before) upon drawing down the 2nd tranche from the Invus/Sofinnova/UPMC funding.We keep the name under review following withdrawal of the MAA in the EU and will come back with an update as soon as we have more clarity on LUMEVOQ®'s strategy going forward.GenSight Biologics is a clinical-stage biotechnology company based in France. Co. is engaged in discovering and developing novel therapies for mitochondrial and neurodegenerative diseases of the eye and central nervous system by combining a gene therapy-based approach with its core technology platforms of mitochondrial targeting sequence, or MTS, and optogenetics. Co.'s initial focus has been on developing therapies for severe retinal diseases, with the goal of preserving or restoring vision in patients suffering from sight-threatening ophthalmic diseases. Co.'s product pipeline comprises two candidates for the treatment of sight-threatening retinal degenerative diseases, GSO1O and GSO3O.
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