Disc Medicine reports the phase 3 APOLLO trial met all primary and secondary end points, with whole-blood PPIX reduced 41.4% vs placebo and an NDA resubmission planned by end of 2026.
The FDA clearance allows Edesa to expand an ongoing placebo-controlled study of the CXCL10 antibody EB06 to US sites, with topline data expected in the fourth quarter of 2027.
The novel oral helicase-primase inhibitor demonstrated significantly higher rates of complete lesion healing compared with investigator’s choice treatment in the phase 3 PRIOH-1 trial.