D-PLEX100 has received Breakthrough Therapy Designation, three QIDP designations, and three Fast Track designations from the U.S. Food and Drug Administration. NDA submission is expected early 2026.

D-PLEX₁₀₀ has received Breakthrough Therapy Designation, three QIDP designations, and three Fast Track designations from the U.S. Food and Drug Administration. NDA submission is expected early 2026.

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