(CercleFinance.com) – GenSight Biologics jumped more than 30% on Wednesday morning on the Paris Stock Exchange after an update on its discussions with the European Medicines Agency (EMA) concerning its main product candidate.
In a press release, the biopharmaceutical company indicates that the main characteristics of its new phase III study of Lumevoq, its gene therapy project for the treatment of Leber’s hereditary optic neuropathy (LHON), have been approved.
This randomized trial, called ‘Recover’, will be divided into two treatment arms: a control arm in which a simulated procedure mimics an injection in each eye without any substance being injected, and an active arm, in which subjects will receive a bilateral intravitreal injection of Lumevoq.
According to the EMA, this study protocol appears acceptable for evaluating the benefits of the drug in patients requiring treatment of both eyes.
The study was designed to answer questions raised by an EMA expert committee, which led GenSight to withdraw this file last April in order to discuss the reservations made by the agency.
GenSight plans to initiate the study in the second quarter of 2024, and complete it by the second half of 2026.
The biotech adds that it intends to share the main characteristics of the protocol with other regulatory authorities, such as the British Agency (MHRA) and the American FDA.
The stock is currently up 32%, marking the strongest growth on the Parisian market, but is still down 84% since the start of the year.
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