FDA approves IND application for GNTbm-38 for Ph 1 trial in Advanced Solid Tumors and R/R PTCL March 10, 2026
FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma February 1, 2026
NCCN® Duvelisib (COPIKTRA®) Update to Clinical Practice Guidelines in Oncology for CTCL December 22, 2025
PTX-100 receives US FDA Fast Track Designation for the treatment of adults with R/R mycosis fungoides, the most common subtype of CTCL April 22, 2025
Update relating to Resminostat’s (Kinselby) Marketing Authorisation Application announced March 18, 2025
HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage CTCL January 21, 2025
Enrollment completed in Ph 2 proof of concept 065-101 study of fadraciclib in patients with advanced solid tumors and lymphoma; ongoing in T-Cell Lymphoma cohort October 2, 2024
Additional Positive Efficacy Data with BI-1808 monotherapy from Ph 2a anti-TNFR2 program Announced September 17, 2024
Randomized controlled trial of Nana-val in EBV-positive PTCL patients planned to begin in the second half of 2025 to support potential registration August 27, 2024
FDA Approves LYMPHIR™ (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with R/R Cutaneous T-Cell Lymphoma August 13, 2024
FDA Fast Track Designation Granted to Soquelitinib for Treatment of Patients with R/R PTCL August 6, 2024
Expanded HyBryte™ Treatment Demonstrating Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma July 17, 2024
Positive Topline Nana-val Results from Stage 1 of the NAVAL-1 Trial in Patients with R/R EBV+ PTCL Announced April 16, 2024
