SL Science Holding Ltd. (SLBT), a biomedical company developing cellular and gene therapies, announced that it has submitted an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration or FDA for its Gamma Delta T (GDT) cell therapy product, Vdelta2+ Gamma Delta T Cells, for the treatment of Glioblastoma multiforme or GBM.
Glioblastoma multiforme is among the most aggressive and lethal forms of primary brain cancer, and with the current standard of care, the median survival is around 15 months, says SL Science Holding.
SL Science Holding develops cellular and gene therapies, including Gamma Delta T-cell therapies targeting solid tumours such as pancreatic and brain cancers.
The FDA grants Orphan Drug Designation to therapies targeting rare diseases or conditions affecting fewer than 200,000 people in the U.S. annually, or those that meet certain economic criteria.
The Office of Orphan Products Development (OOPD) at the FDA acknowledged receipt of the application and is currently reviewing additional files related to the submission.
"Submitting the ODD is a critical step forward in our strategy to accelerate the clinical development of our GDT cell platform," said William Wang, Chairman and Chief Executive Officer of SL Science.
For the full year 2025, the company's revenue slipped 35% to $2.20 million from $3.36 million in the prior year.
For 2025, net loss widened to $3.82 million from $1.19 million in the prior year.
As of December 31, 2025, SL Science's restricted and unrestricted cash balances were approximately $1.26 million.
SLBT has traded between $3.00 and $14.50 over the last year. The stock closed Friday's (10-07-2026) trade at $4.73, up 3.73%.
In the overnight market, SLBT is down 3.81% at $4.55
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