TransCode Therapeutics to acquire Polynoma and use $25M funds by CK Life Sciences to advance TTX-MC138 into Ph 2 trial October 16, 2025
Libtayo® (cemiplimab-rwlc) Approved in US for Adjuvant Treatment of CSCC with a High Risk of Recurrence After Surgery and Radiation October 15, 2025
FDA Fast Track Designation to WTX-124 for locally advanced or metastatic cutaneous melanoma after SOC immunotherapy October 15, 2025
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
