ProKidney Decides To Prioritize PROACT 1; Plans To Discontinue PROACT 2, Which Was Focused On Enrollment Outside US; Now Expects Current Cash To Support Operating Plans Into Q1 2027
ProKidney Decides To Prioritize PROACT 1; Plans To Discontinue PROACT 2, Which Was Focused On Enrollment Outside US; Now Expects Current Cash To Support Operating Plans Into Q1 2027
The Company believes rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial.
公司認爲rilparencel符合迅速批准途徑的條件，基於正在進行的第3期REGEN-006 (PROACt 1)試驗的成功完成。
ProKidney believes that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration. Thus, the Company will discontinue PROACT 2, which was focused on enrollment outside the U.S. With the discontinuation of PROACT 2, ProKidney now expects current cash to support operating plans into Q1 2027.
ProKidney認爲第3期REGEN-016 (PROACt 2)試驗對於美國初步註冊並不是必需的。因此，公司將終止PROACt 2，該試驗側重於美國以外的入組。隨着PROACt 2的終止，ProKidney現在預計當前現金能夠支持至2027年第一季度的運營計劃。
The Company estimates the revised Phase 3 program will deliver topline results by Q3 2027 and reduce expenses by approximately $150 to $175 million.
公司預計修訂後的第3期項目將於2027年第三季度發佈最終結果，並將支出減少約1.5億至1.75億美元。
