NGM Bio Shares Rise After Vision Disorder Candidate Receives FDA Fast Track Tag

The FDA has granted Fast Track designation to NGM Biopharmaceuticals Inc's 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 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.