OS Therapies completed requalification of Herlystic drug substance, supporting a confirmatory Phase 3 trial and a UK conditional marketing application. Manufacturing data delays pushed expected UK regulatory decisions to the first quarter of 2027; the company said financing and refundable tax programs can fund operations through mid-2027.
OS Therapies completed requalification of Herlystic drug substance used in its Phase 2b osteosarcoma trial, supporting a confirmatory Phase 3 trial. The milestone enables submission of a UK conditional marketing application for early commercial access, alongside an application for Phase 3 trial authorization.
Stability results showed the drug substance retained its critical quality attributes during storage. Manufacturing data delays pushed expected regulatory decisions to the first quarter of 2027 in the UK, compared with the first half of 2027 in Europe. The company said recent financing and refundable tax programs provide sufficient resources to fund operations through mid-2027.
