Gem Snags Orphan Drug Designation for GPX-150

Gem Pharmaceuticals’ lead candidate has landed a win from the FDA with a new classification as an orphan drug.

Soft tissue sarcoma candidate GPX-150 — now in Phase 2 trials — nabbed the rare-disease title, which will offer the sponsor incentives, such as tax credits for development costs and lowered application prices.

Results are expected from the study by Q4 of this year, Gem has said. The drugmaker is hoping the anthracycline will eliminate heart-related side effects associated with current chemotherapies, providing an alternative to doxorubicin and others.