OS Therapies announced that the World Health Organization’s International Nonproprietary Names Expert Committee has approved the generic name ‘daznelimgene lisbac’ for its lead product candidate OST‑HER2, a listeria‑based immunotherapy designed to target HER2‑expressing osteosarcoma cells.
The INN approval is a critical regulatory milestone that allows OS Therapies to file marketing authorization applications in the United States, Europe, and other markets. It also ensures a globally recognized name that facilitates clear identification, safe prescription, and dispensing once the therapy receives regulatory approval.
OST‑HER2 has already secured several key designations: a Rare Pediatric Disease Designation (RMAT) from the FDA, a Biologics License Application number in preparation for an accelerated approval submission, and conditional approval from the U.S. Department of Agriculture for use in canine osteosarcoma. These achievements position the product for accelerated pathways and support the company’s goal of delivering the first new pediatric osteosarcoma treatment in four decades.
CEO Paul Romness said the INN milestone is a “critical step toward regulatory feedback in December 2025 and filing in January 2026.” He highlighted the company’s momentum in the second quarter and its focus on bringing a first‑in‑class therapy to patients worldwide.
The approval opens the door to marketing authorization submissions and accelerates the company’s regulatory timeline. It also underpins the planned spin‑off of OS Animal Health, which will commercialize OST‑HER2 for canine osteosarcoma, and strengthens investor confidence in the company’s growth strategy.
OST‑HER2 is a first‑in‑class listeria‑based immunotherapy that has met its primary endpoint in a Phase 2b trial. The company is on track to submit a BLA for accelerated approval and could qualify for a priority review voucher if the conditional BLA is approved before September 30 2026. The INN approval therefore represents a pivotal step in the product’s development and commercialization journey.
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