03:52 AM EDT, 09/03/2026 (MT Newswires) -- Sensorion (ALSEN.PA) received clearance in France to launch the phase 1/2 HearConnex trial of its lead gene therapy candidate, SENS-601, for GJB2-related hearing loss. The clinical-stage biotechnology company said Thursday the French National Agency for Medicines and Health Products Safety, or ANSM, approved the clinical trial after fast-track assessment. The open-label study will assess the safety and tolerability of SENS-601 in the initial phase and its efficacy in an expansion cohort after bilateral intra-cochlear administration in the second phase. Dosing is targeted to start in early 2027. The review of Sensorion's clinical trial application for SENS-601 in Canada remains on track, while submission of a similar application in Australia is expected by the end of 2026. The company is also looking to submit the investigational new drug application for SENS-601 in the US by the end of 2026.

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