11/09/2026 Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules Immutep refocuses eftilagimod alfa development on PD-L1-negative (CPS <1) HNSCC and neoadjuvant STS following TACTI-004 discontinuation SERENA-4 Phase 3 trial of Etcamah + palbociclib missed its primary PFS endpoint in 1L ER+/ HER2- advanced breast cancer Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules (Ref) Handa Pharmaceuticals has received final US FDA approval for OMCA

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