Blacksmith Medicines received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for FG‑2101, an LpxC inhibitor targeting Gram‑negative pathogens. The regulatory designations add five years of exclusivity and priority review pathways, accelerating the program’s clinical and development timeline. Blacksmith said the designations reflect the unmet need for new mechanisms against drug‑resistant Gram‑negatives and will inform its regulatory strategy and interactions with U.S. authorities as it prepares clinical development plans.