(News Bulletin 247) – The GenSight Biologics share lost nearly 65% of its value on Friday on the Paris Stock Exchange following the withdrawal of its application for marketing authorization in Europe for Lumevoq, its main product candidate.
Long reserved for the decline, the biotech title is currently losing 64.9%, suffering by far the largest drop in the Parisian market, which brings its market capitalization down to 38 million euros.
GenSight announced in a statement last night that it has decided to withdraw its application following an assessment of the product by the Committee for Medicinal Products for Advanced Therapies (CAT) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). ).
The aim, according to GenSight, is to engage in discussions with the EMA on the best possible path for Lumevoq in the coming weeks, with the aim of submitting a new application in Europe ‘as soon as possible’.
For the record, this gene therapy targets Leber’s hereditary optic neuropathy (LHON).
The company says it is currently studying various possible options, including the production of new clinical data, which can lead to significant delays and additional costs.
Faced with these uncertainties, analysts at Degroof Petercam placed their buy recommendation and their target price of 8.5 euros on the stock under review.
At Invest Securities, it is also disarray that prevails after this unexpected announcement.
‘If GenSight’s decision seems the most judicious given the situation, it is the EMA’s position which seems to us today the most surprising in view of the interactions made so far’, comments Invest Securities.
‘Indeed, the EMA had shown itself to be rather ‘supportive’ throughout the regulatory process and upstream, in particular with the granting of several deadlines due to the various manufacturing problems encountered, but above all because the essential clinical data was known and it seemed that the main problem was of a manufacturing nature, ”recalls the stockbroking company.
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