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Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) Ready to Announce with Confidence?

newsfilecorp.com

Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) Ready to Announce with Confidence? Dallas, Texas--(Newsfile Corp. - May 12, 2026) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced materially through late-stage regulatory and commercialization preparation as OST-HER2 moved from Phase 2bsupported planning toward a more defined global approval pathway in recurrent, fully resected, pulmonary metastatic osteosarcoma. The key change is greater regulatory clarity: EMA initiated rolling review of the OSTHER2 Conditional Marketing Authorization dossier, while EMA and Australia's TGA aligned on 3-year overall survival as the approvable efficacy endpoint. Management also positioned seroconversion biomarker data as supportive surrogate efficacy evidence, shifting the investment debate from early proof-of-concept toward execution across a dense 2026 catalyst calendar. Key milestones include 2.5-year OS data in mid-2Q26, FDA/MHRA meetings in 2Q26, Phase 3 initiation in Australia in 3Q26, 3-year OS data in early 4Q26, and a potential EMA CMA decision in 4Q26.

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Key Takeaways:

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About Stonegate

Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.

Contacts:

Stonegate Capital Partners

(214) 987-4121

info@stonegateinc.com

Source: Stonegate, Inc.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/297183

Source: Reportable, Inc.

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