GenSight Biologics (Euronext: SIGHT, a biopharmaceutical company that develops and commercialises gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced on Wednesday that it has received confirmation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) that it could accept a marketing authorisation application for LUMEVOQ with the most recent clinical data. The application is planned for H2 2024, with a potential decision by H2 2025. The MHRA's acceptance is not contingent on data from the upcoming RECOVER trial.

The manufacturing update reveals a decision to merge two successful Drug Substance batches into one Drug Product batch, optimizing vial availability. The fully released product is now expected in Q3 2024, compared to the initial estimate of early Q2 2024.

Financially, GenSight extended its cash runway to mid-February 2024, with ongoing discussions to bridge the AAC resumption in France in Q3 2024, requiring an estimated €EUR14m. The company actively engages with shareholders and explores strategic opportunities, including mergers, acquisitions, or licensing deals.

The company's lead product candidate, LUMEVOQ (GS010), aims to treat Leber Hereditary Optic Neuropathy, a rare mitochondrial disease causing irreversible blindness. GenSight's gene therapy-based approach offers a single-treatment solution for functional visual recovery.