jCyte Announces Pre-Phase 3 Type B Meeting with FDA; Outlines Plans to Start Pivotal Trial of jCell for RP

jCyte announced the successful outcome of its pre-phase 3 Type B meeting with the FDA held on January 16, 2024. Additionally, the company is gearing up to commence its pivotal US trial for jCell for retinitis pigmentosa (RP) in the second half of 2024.

John Sholar, Chief Executive Officer of jCyte, said he was satified with FDA’s review of the planned phase 2/3 clinical trial design, including FDA’s approval of the primary endpoint and the two jCell doses to be included in the study, as well as the FDA’s responses to jCyte’s description of its CMC program.

“We are pleased with the Type B meeting minutes, which enable us to move forward with the US pivotal trial. Enrollment is expected to begin the second half of this year and more information will be shared when appropriate," Mr. Sholar said.