Shares of OS Therapies Inc. (OSTX) were gaining around 12% in the pre-market activity after the company announced Thursday that it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration. The meeting would review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.
The clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company said it expects the meeting to occur in the third quarter of 2025.
The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access.
OST-HER2 is an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells.
OS Therapies said it intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application or BLA submission for OST-HER2. With the Rolling Review process, a company can submit completed sections of its BLA for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. This can contribute to augmented interactions with FDA and potentially an expedited BLA approval timeline.
OST-HER2 has received FDA Orphan Disease Designation or ODD, Fast Track and Rare Pediatric Disease Designation or RPDD from FDA. Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher or PRV that it intends to sell. The most recent PRV sale, valued at $160 million, occurred in June 2025.
On the NYSE American, OS Therapies shares are currently trading at $2.1300, up 11.52 percent.
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