secwatch.observer — SEC 8-K summary
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Issuer:     OS Therapies Inc (OSTX)
CIK:        0001795091
Form:       8-K
Filed at:   2026-04-30T23:59:59+00:00
Accession:  0001213900-26-050211
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

EMA rolling review for OST-HER2; ATGA aligns on 3-year OS endpoint; peak EU sales >$300M
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- EMA initiated rolling review of OST-HER2 CMA for preventing recurrence in resected pulmonary metastatic osteosarcoma.
- EMA and Australia TGA agreed 3-year overall survival as approvable endpoint; seroconversion data supports CMA.
- UK MHRA granted Advanced Therapy Medicinal Product (ATMP) designation to OST-HER2.
- Company forecasts peak European osteosarcoma sales exceeding $300M, with over $50M expected in 2027.
- Confirmatory Phase 3 trial initiation planned for Q3 2026 in Australia; FDA and MHRA meetings in Q2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1795091/000121390026050211/0001213900-26-050211-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1795091/000121390026050211/ea0288588-8k_ostherapies.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-050211

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer