uniQure reports Q3 EPS (91c), consensus ($1.01)

Reports Q3 revenue $2.287M, consensus $6.79M. “uniQure (QURE) has made significant strides during the third quarter both clinically and operationally. We advanced our pipeline of clinical gene therapy programs, including the presentation of positive long-term follow-up data on AMT-130 supporting significant, dose-dependent slowing of Huntington’s disease progression,” stated Matt Kapusta, chief executive officer of uniQure. “We have scheduled a Type B meeting with the FDA for late November and welcome the opportunity, as part of the Regenerative Medicine Advanced Therapy (RMAT) designation, to discuss the potential for an accelerated development pathway for AMT-130. We believe the recently announced compelling clinical data, combined with AMT-130’s manageable safety profile and the lack of therapeutic options for patients in need, present a strong case for accelerated development. In addition, dosing has begun across two new Phase I/II studies in SOD1-ALS and Fabry disease, and we are making substantial progress towards the initiation of a third clinical trial in mesial temporal lobe epilepsy, with the first patient recently enrolling into the observational phase of the study.”