Global Ph 3 study of HBI-8000 plus nivolumab met the PFS primary endpoint in frontline patients with advanced melanoma July 15, 2026
FAILED TRIAL: Ph 3 Trial of Fianlimab Combination in 1L Unresectable or Metastatic Melanoma did not reach statistical significance for PFS improvement May 21, 2026
FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers May 12, 2026
Study initiated to evaluate Pidnarulex (CX-5461) + tislelizumab in pancreatic cancer, colorectal cancer, and melanoma May 12, 2026
Fast Track Designation for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma May 12, 2026
Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement and $350 Million Concurrent Private Placement April 21, 2026
Orphan Drug Designation Application Submitted to US FDA for SkinJect® for treating basal cell carcinoma (BCC) in patients with Gorlin Syndrome April 21, 2026
Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma April 15, 2026
Hoth Therapeutics Deploys OpenAI API to Advance Development of Orphan HT-KIT Oncology Program March 10, 2026
Ph 2 SKNJCT-003 Trial Reported 73% Clinical Clearance and 40% Histological Clearance (CR) with D-MNA in BCC March 10, 2026
52% Amtagvi Response Rate with Two or Fewer Prior Lines of Therapy 73% Overall DCR in Melanoma Announced February 9, 2026
Multiple Sites Activated for Ph 1b/2 Trial of AMXT 1501 and DFMO in Patients with solid tumors including Breast Cancer and Melanoma February 9, 2026
Ph 1/2 Program Initiated for Elraglusib in refractory melanoma and additional target solid tumor and heme cancers January 25, 2026
5-Year Data for Intismeran Autogene + KEYTRUDA combo Demonstrated Sustained RFS Improvement in High-Risk Stage III/IV Melanoma Following Complete Resection January 25, 2026
Faron announces strategic collaboration with The Institute for Cancer Research to launch BLAZE trial of bexmarilimab + zimberelimab December 30, 2025
Latest Data Demonstrating Clinical Activity and Favorable Safety for NUC-7738 in Patients with PD-1-Resistant Melanoma December 15, 2025
FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced CSCC December 9, 2025
FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced CSCC December 2, 2025
