Reduced Net Loss
The net loss for Q3 2024 was $32.2 million or $0.56 per share, a significant improvement from the $56 million or $0.97 per share in Q2 2024.
Progress in Drug Development Programs
Ongoing development and Phase III program initiation for zaltenibart (OMS906), targeting PNH and C3G, with positive efficacy and safety data.
Regulatory Milestones
FDA pre-submission meeting for narsoplimab BLA resubmission was collaborative, with minor additional feedback requested. European marketing authorization application (MAA) for narsoplimab expected in H1 2025.
Rare Pediatric Disease Designation
zaltenibart received FDA rare pediatric disease designation for C3 glomerulopathy, potentially leading to a priority review voucher.
OMIDRIA Revenue Prospects
Expansion of separate payment for OMIDRIA in hospital outpatient departments starting January 2025, expected to grow sales significantly in the U.S.