Dimerix (ASX:DXB) is approaching key catalysts, including potential interim results, which could potentially enable a faster approval in the US in 2026 and first sales immediately thereafter, according to a Sunday note by Euroz Hartleys.
Its interim analysis, expected between late 2025 and early 2026, will determine whether its drug candidate demonstrates efficacy at this point in the trial. It will only proceed if the US Food and Drug Administration (FDA) agrees to the interim analysis, the firm is satisfied with the FDA's terms, a powering analysis supports it, and the trial is fully recruited.
A blinded statistical power analysis, expected in the December quarter, will verify if Dimerix's trial has adequate statistical power for the confirmatory endpoint, confirming enough patients have been enrolled to detect a meaningful effect at study completion.
The investment firm maintained its speculative buy recommendation on Dimerix and its AU$1.68 per share price target.