FDA recommends no BLA submission based on IOB-013 trial data; new registrational study for Cylembio for the treatment of 1L melanoma planned September 30, 2025
Type A meeting with FDA completed to discuss the CRL for RP1 + nivolumab BLA in melanoma September 23, 2025
Type A meeting scheduled with FDA scheduled to discuss CRL for BLA for RP1 + nivolumab combo in advanced melanoma September 3, 2025
FDA accepted Type C meeting request for Doxorubicin Containing Novel Microneedle Array (D-MNA); SKNJCT-003 Ph 2 study randomize more than 75% of patients August 26, 2025
FAILED TRIAL: Clinical but not significant PFS Improvement seen in Ph 3 Trial of Cylembio® plus KEYTRUDA® in 1L Advanced Melanoma August 12, 2025
Real-World Data Demonstrate a 49% Response Rate for Commercial Amtagvi® in Patients with Advanced Melanoma July 15, 2025
Type C meeting with the FDA requested to discuss the D-MNA product development and gain further alignment on the clinical pathway July 15, 2025
Ph 3 Accelerated Approval Trial of IFx-2.0 as an Adjunctive Therapy to Keytruda in 1L Treatment for Advanced or Metastatic MCC initiated July 1, 2025
New arm (Cohort 4) initiated in SCOPE Ph 2 study to evaluate intradermal administration and an accelerated dosing regimen for iSCIB1+ June 26, 2025
Teva and Fosun Pharma Enter into a Strategic Partnership to Develop Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology June 17, 2025
FDA Removes Partial Clinical Hold from Ph 3 Trial of IFx-2.0 in Advanced or Metastatic Merkel Cell Carcinoma June 11, 2025
Clinical development of nemvaleukin to discontinue following review of data from Ph 2 ARTISTRY-6 and Ph 3 ARTISTRY-7 trials April 22, 2025
FAILED TRIAL: Ph 3 RELATIVITY-098 trial of Opdualag™ (nivolumab and relatlimab-rmbw) in adjuvant, stage III-IV melanoma did not meet its primary endpoint of RFS February 19, 2025
BLA accepted, Priority Review granted for RP1 for the Treatment of Advanced Melanoma January 28, 2025
Adjuvant Libtayo® (cemiplimab) Significantly Improves DFS After Surgery in High-Risk CSCC in Ph 3 Trial January 15, 2025
First patient enrolled in Ph 1b/2a study of BI-1607 in combination with ipilimumab and KEYTRUDA in patients with unresectable or metastatic melanoma December 26, 2024
FDA Approves UNLOXCYT™ (cosibelimab-ipdl) for advanced cutaneous squamous cell carcinoma December 18, 2024
FDA Clearance received to Administer AIV001 in Facial Skin by Intradermal Injection for Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC) December 18, 2024
