24/7 Market News Snapshot 24 June, 2025 – OS Therapies Incorporated (NYSE:OSTX)

June 24, 2025

DENVER, Colo., 24 June, 2025 (www.247marketnews.com) – (NYSE:OSTX) are discussed in this article.
OS Therapies Incorporated (NYSE-A: OSTX) is experiencing significant momentum in pre-market trading, with shares rising to $1.858, marking a 9.29% increase from the prior closing price of $1.700 on elevated trading volume of 621.72K shares. This surge indicates heightened investor interest and positive market sentiment, potentially influenced by favorable developments and prospects tied to the company’s innovative pipeline.

A notable catalyst for this bullish trend is the recent Type D Meeting with the U.S. Food & Drug Administration (FDA), where OS Therapies received encouraging feedback regarding the necessary endpoints for an Accelerated Approval Program marketing application. This discussion pertains to the company’s ongoing Phase 2b clinical trials of OST-HER2, aimed at preventing or delaying recurrence in fully resected pediatric lung metastatic osteosarcoma. In light of the meeting’s productive outcomes, OS Therapies has submitted requests for both an End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) to the FDA, with the End of Phase 2 meeting expected in the third quarter of 2025.

Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies, expressed optimism regarding the FDA’s openness to utilizing external control comparators in situations where traditional placebo-controlled trials are impractical, particularly for rare pediatric diseases. He highlighted the meeting’s insights as instrumental for preparations ahead of the End of Phase 2 discussions and the strategic pathway to securing a Biologics Licensing Application (BLA) via Accelerated Approval.

Recently awarded Rare Pediatric Disease Designation, OST-HER2 could yield substantial benefits, including qualification for a Priority Review Voucher if the BLA is granted before September 30, 2026. As OS Therapies advances its differentiated oncology solutions, it remains steadfast in addressing significant unmet medical needs in the treatment of rare cancers, particularly within pediatric settings.

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