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OS Therapies Requests Meeting with FDA to Gain Agreement on Surrogate Endpoint(s) for Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma

1. OSTX seeks FDA meeting for Breakthrough Therapy and Accelerated Approval alignment. 2. Successful outcomes could expedite OSTX's clinical pathways and market potential.

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Why Bullish?

Seeking FDA alignment indicates potential acceleration in development timelines. Historically, similar FDA engagements have positively impacted stock prices in biopharma.

How important is it?

The FDA alignment can significantly influence OSTX's market strategy and investor confidence. A favorable outcome increases the company's viability and attractiveness to investors.

Why Short Term?

Immediate investor reaction expected as developments unfold with the FDA. Previous FDA communications often lead to rapid stock price changes.

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NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval v.

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