OS Therapies has secured full alignment with the UK MHRA and European EMA on its Conditional Marketing Authorisation Application (CMAA) for its gene-edited cancer immunotherapy OST-HER2 targeting metastatic osteosarcoma. The regulators agreed on using historical control data and the Phase 3 trial design, which OS Therapies plans to start in Q4 2026. The company aims to submit the CMAA soon and is also pursuing FDA approval under the Accelerated Approval Program, potentially gaining early market access and a Priority Review Voucher. This regulatory progress marks a significant step toward commercializing OST-HER2, which has shown promising Phase 2 results in preventing recurrence of osteosarcoma.
OS Therapies' regulatory progress is noted here alongside Pluang's market data for health stocks. For readers following health stocks, here is Pluang's market snapshot as of Sep 15, 2026 18:13 WIB: out of 91 priced US health stocks, 31 rose and 54 fell. Notable movers include ASND at USD 258.00 (-2.61%), INO at USD 1.21 (+2.54%), and DNA at USD 6.86 (-2.14%).
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