Viridian Therapeutics posted positive Phase 3 top-line results for elegrobart (VRDN-003) in chronic thyroid eye disease, clearing the way for planned regulatory filings. The company said the trial met both primary endpoints needed for a U.S. BLA and an EMA submission. Elegrobart, delivered subcutaneously via autoinjector for at-home use, targets the insulin-like growth factor-1 receptor with a half-life extension. The endpoints included a proptosis responder rate measured by exophthalmometry for the U.S. filing and an overall responder rate for the European pathway. The update intensifies competition in TED, a progressive autoimmune condition, by adding a next-generation candidate alongside Amgen’s Tepezza and Viridian’s own veligrotug in FDA review. Market attention is likely to focus on durability, safety tolerability, and responder definitions as companies prepare for regulator-facing packages. With the filing window anticipated for early 2027, the Phase 3 readout also changes how clinicians may sequence TED therapy lines in Graves’ eye disease.
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