The FDA has granted Fast Track designation to NGM Biopharmaceuticals Inc's (NASDAQ:NGM) NGM621, a monoclonal antibody to inhibit complement C3, for geographic atrophy (GA) secondary to age-related macular degeneration.
- NGM Bio is currently evaluating NGM621 in its ongoing Phase 2 CATALINA study, and a topline data readout is expected in Q4 of 2022.
- GA is an advanced form of age-related macular degeneration characterized by progressive retinal cell loss resulting in irreversible vision loss.
- NGM621 is a proprietary humanized Immunoglobulin 1 monoclonal antibody product candidate engineered to potently bind to and be a long-acting inhibitor of complement C3 activity.
- NGM Bio discovered NGM621 under its strategic collaboration with Merck & Co Inc (NYSE:MRK).
- The Phase 2 CATALINA study enrolled 320 patients to evaluate the efficacy and safety of NGM621 when given every four weeks or every eight weeks via IVT injections compared to sham control.
- Price Action: BGM shares are trading 3.55% higher at $16.18 on the last check Monday.
