Dimerix's (ASX:DXB) decision to conduct a blinded review of the Action3 phase 3 study data to confirm statistical assumptions of the primary endpoint after reaching alignment with the US Food and Drug Administration on the relevant endpoints and review process suggests productive ongoing dialogue between the firm and the regulator, Euroz Hartleys said in a note on Tuesday.
The phase 3 Action3 trial is a placebo-controlled study of the efficacy and safety of the company's DMX-200 drug candidate in patients with focal segmental glomerulosclerosis who are receiving a stable dose of a blood pressure medication known as an angiotensin II receptor blocker.
Should the results prove successful, an interim analysis could enable the firm to pursue accelerated approval and early US commercialization.
The investment firm maintained its speculative buy rating and AU$1.65 price target on Dimerix.
Dimerix's shares jumped past 7% in recent Tuesday trade.