Os therapies receives positive feedback from uk mhra scientific advice meeting and submits innovative licensing and access pathway (ilap) request for ost-her2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

Mhra seeks to harmonize uk & us regulatory review via project orbis ema rapporteur scientific advice meeting scheduled for october 2025 new york, new york--(newsfile corp. - august 7, 2025) - os therapies (nyse american: ostx) ("os therapies" or "the company"), a clinical-stage immunotherapy and antibody drug conjugate (adc) biopharmaceutical company, today announced that it held a successful scientific advice meeting with the united kingdom's (uk) medicines and healthcare products regulatory agency (mhra) in july and has submitted an invited innovative licensing and access pathway (ilap) application to begin the regulatory process towards approval of ost-her2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. mhra suggested applying for project orbis at the time of regulatory approval submission to synchronize its marketing authorization application process with the united states food & drug administration's (fda) biologics licensing application (bla) accelerated approval program.
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