Coya Therapeutics, Inc.: Promising Advancements in ALS and FTD Treatment with COYA-302We see the trial as relatively risk-reduced (as much as anything in ALS can be) after the initial ALS pilot study halted disease progression in patients who were steadily declining at baseline—replicating this in larger cohorts would be transformational. For context, a 30% slowing of decline is typically viewed as clinically meaningful in progressive diseases. Following extensive FDA engagement, the IND was resubmitted. Management has noted the agency treated it as a novel therapeutic, not merely a combination of two biosimilars for approved products. Accordingly, management believes their tox package is sufficient to support a BLA, assuming the upcoming trial demonstrates efficacy and safety.