- In February 2025, Kyowa Kirin announced Phase III results for its investigational antibody therapy in Sézary Syndrome, demonstrating improved overall response rate and durable symptom relief. This advancement strengthens clinical confidence and is expected to accelerate regulatory approvals, boosting market uptake
- In November 2024, Soligenix received Fast Track Designation from the U.S. FDA for SGX301, a synthetic hypericin-based photodynamic therapy for treatment-resistant CTCL. This designation speeds up the development timeline, potentially bringing innovative therapies to market faster and expanding treatment options
- In September 2024, Helsinn and a U.S.-based academic center launched a joint clinical trial investigating an oral HDAC inhibitor combination regimen for Sézary Syndrome. This collaboration is expected to drive innovation in oral treatment regimens, improving patient convenience and expanding the addressable market
- In June 2024, Innate Pharma received orphan drug designation for its anti-KIR3DL2 antibody IPH4102, advancing its CTCL pipeline in both Europe and the U.S. The designation provides development incentives, enhancing the commercial viability and market penetration of novel CTCL therapies
- In April 2024, Seattle Genetics expanded its licensing agreement with Takeda to include Asia-Pacific development rights for brentuximab vedotin in CTCL indications, including Sézary Syndrome. This strategic expansion broadens geographic access, supporting regional market growth and increased drug availability in high-need areas
