15/04/2026 FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma FDA Grants Fast Track to Opna Bio’s OPN-6602 for Relapsed/Refractory Multiple Myeloma FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma (Ref) Immutep’s lead candidate, eftilagimod alfa (efti), has received Orphan Drug Designation from the U.S. FDA for soft tissue sarcoma (STS), a rare cancer with high unmet need Supporting clinical data: Based on resu

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS (Ref) The US FDA granted the fast track designation to Adcendo's ADCE-D01 (uPARAP-targeting ADC) for the treatment of soft tissue sarcoma (STS). Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including STS and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific t

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref) The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. Guy Travis Clifton, CMO, Calidi: “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the