Medix to submit final version of tesofensine application following interaction with COFEPRIS
Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that its partner Medix sees a clear regulatory path forward for tesofensine following discussions with the Mexican regulatory agency COFEPRIS.
Since the message from COFEPRIS, communicated in Saniona’s press releases of November 6 and November 12, 2024, Productos Medix S.A. de S.V. (Medix) has worked closely with COFEPRIS on the approval pathway for tesofensine in Mexico. Following these discussions, Medix now sees a clear path to regulatory approval and is revising its application based on COFEPRIS’s feedback. Medix expects to resubmit the dossier in February.