SynAct Pharma recieves pre-IND response from the US FDA
SynAct Pharma AB (“SynAct”) today announced that the company was granted and has received written response from the US Food and Drug Administration (FDA) on the request for a Type B pre-IND meeting on the planned development of AP1189 oral tablets for treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate alone (DMARD-IR). Based on the response, the Company will submit an investigational new drug (IND) application according to plan.“FDA’s guidance on our development program for AP1189 is of outmost importance. Not only does it help us to align with the