This information is intended for investors and the financial community.
GenSight Biologics reminds investors that the company’s lead product candidate, GS010/LUMEVOQ®, currently in clinical development, has not yet formally demonstrated its clinical efficacy and safety. It has not been granted marketing authorization in any jurisdiction and is therefore not available commercially.
The application for named patient early access (AAC) submitted by GenSight Biologics in France is currently being reviewed by the relevant authority – the ANSM – on the basis of the available clinical data.