GenSight Biologics is trading higher on the Paris Bourse on Wednesday, following an update on its operational and financial situation.

In a press release, the biopharmaceutical company states that a scientific opinion has confirmed that the UK Medicines and Healthcare products Regulatory Agency (MHRA) is considering an application for marketing authorization for Lumevoq, its gene therapy for Leber's hereditary optic neuropathy (NOHL).

The company points out that this opinion is based on the most recent clinical data from existing studies, without necessarily including data from the forthcoming 'Recover' trial, which would complete the dossier at a later date.

As a result, GenSight expects to submit a marketing authorization application in the UK in the second half of fiscal 2024, with the aim of a decision in the second half of 2025.

GenSight - which estimates its cash flow horizon at mid-February 2024 - estimates that it will need around €14 million to finance its activities until July 2024.

The company explains that it is in active discussions with existing and potential shareholders to finance its activities from mid-February through to the third quarter of 2024.

The share price is currently up nearly 3%, but is still down 85% this year, following the withdrawal in April of its application for marketing authorization in Europe for Lumevoq.

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