OSTX OS Therapies

OS Therapies Plans Q4 2026 BLA & CMAA Submissions for Herlystic (daznelimgene lisbac) in Osteosarcoma

OS Therapies reiterated its plan to submit a BLA to FDA under Accelerated Approval and Conditional Marketing Authorisation Applications to MHRA, EMA and TGA in Q4 2026 for Herlystic in resected pulmonary metastatic osteosarcoma. The financing extends cash runway to support these regulatory filings.

OS Therapies targets Q4 2026 MHRA CMAA and US BLA for daznelimgene lisbac (OST-HER2)

OS Therapies plans to submit a Conditional Marketing Authorization Application to the MHRA under Project Orbis via ILAP in early Q4 2026 for OST-HER2 in metastatic osteosarcoma. It will immediately follow with a US BLA under Accelerated Approval and then European and Australian CMAAs. The company is also preparing commercial infrastructure in anticipation of potential approvals.

OS Therapies: OST-HER2 BLA submission targeted for late 2026

OS Therapies is preparing for U.S. Food & Drug Administration (FDA) Type B Statistical Methods and Type B Pre-BLA meetings to gain regulatory alignment for OST-HER2. The company aims for potential early market authorizations in late 2026 and plans to complete the Biologics License Application (BLA) submission under the Accelerated Approval Program by year-end 2026.

OS Therapies: EMA initiates rolling review of OST-HER2 CMA

EMA’s CAT, CHMP and PRAC have begun a rolling review of the OST-HER2 Conditional Marketing Authorisation dossier. The agency and the company have aligned on 3-year overall survival as the approvable endpoint, with 2.5-year OS data due mid-Q2 2026 and 3-year OS data expected early Q4 2026, positioning the EMA for a potential CMA decision in Q4 2026.