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.
The supplemental New Drug Application seeks to expand the use of Ameluz with red light photodynamic therapy beyond the face and scalp to actinic keratoses on the extremities, neck, and trunk.