USFDAJul 10, 2026, 08:02 AM
SL Science Submits Orphan Drug Designation for GBM Therapy
AI Summary
SL Science Holding Ltd announced the submission of an Orphan Drug Designation (ODD) request to the U.S. FDA for its Vdelta2+ Gamma Delta T Cells therapy, aimed at treating glioblastoma multiforme (GBM). The FDA acknowledged receipt of the request on March 30, 2026. This marks a significant regulatory milestone for the company's GDT cell therapy platform. Additionally, JY BioMed, the licensor of the GDT technology, will present preclinical data on the GBM treatment at the 20th World Congress of Basic and Clinical Pharmacology (WCP 2026) in July.
Key Highlights
- SL Science submitted an Orphan Drug Designation (ODD) request to the FDA for its GDT cell therapy product.
- The product, Vdelta2+ Gamma Delta T Cells, targets Glioblastoma Multiforme (GBM).
- The FDA formally acknowledged receipt of the request on March 30, 2026.
- JY BioMed will present preclinical data on the GBM treatment at WCP 2026 from July 12-17.
- GBM is an aggressive brain cancer with a median survival of around 15 months.
- ODD is granted for diseases affecting fewer than 200,000 patients annually in the US.
Price Impact
More from SLBT