OS Therapies Revises OST-HER2 Regulatory Submission Timeline, Focuses on UK MHRA MAA Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 30 2025
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Source: NASDAQ.COM
Regulatory Update: OS Therapies plans to file marketing authorizations for OST-HER2 in the US and UK to prevent or delay recurrent pulmonary metastatic osteosarcoma.
Filing Sequence: The company will prioritize the UK Medicines and Healthcare products Regulatory Agency submission before the US FDA submission, with expected completion dates in December 2025 and January 2025, respectively.
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Analyst Views on OSTX
Wall Street analysts forecast OSTX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OSTX is 11.50 USD with a low forecast of 6.00 USD and a high forecast of 17.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.380
Low
6.00
Averages
11.50
High
17.00
Current: 1.380
Low
6.00
Averages
11.50
High
17.00
About OSTX
OS Therapies Incorporated is a clinical-stage oncology company focused on the identification, development, and commercialization of new class immunotherapy candidates for solid tumors, beginning with osteosarcoma and other solid tumors. Its pipeline includes two drug technologies: OST-HER2 and OST-tADC. Its lead asset, OST-HER2, is an off-the-shelf immunotherapy, which is a type of cancer treatment that helps one’s immune system fight cancer, comprised of a genetically weakened and modified strain of Listeria monocytogenes, a species of bacteria that causes the infection listeriosis, that expresses HER2 peptides. OST-tADC is a tunable ADC with a plug-and-play platform that features tunable pH-sensitive silicone linkers (SiLinkers). Its clinical-stage cancer immunotherapy programs also include OST-AXAL for human papilloma virus (HPV)-associated cancers; OST-503 for non-small cell lung cancer (NSCLC) & glioblastoma; and OST-PSA for prostate cancer.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
OS Therapies (OSTX) Reports Positive OST-HER2 Data but Shares Drop 4.52%
- Clinical Trial Progress: OS Therapies' Phase 2b trial of OST-HER2 revealed that immune blood biomarkers in the interferon gamma pathway effectively distinguish long-term from short-term survivors, bolstering their Biologics License Application (BLA) submission.
- Regulatory Approval Path: The company plans to submit its BLA to the FDA by Q2 2026, with regulatory approvals anticipated in the UK, US, and Europe by the end of 2026, indicating strong potential for market entry.
- Poor Stock Performance: Despite positive clinical data, OSTX shares fell 4.52% to $1.48, trading 2.5% below the 20-day and 12.8% below the 50-day simple moving averages, reflecting market caution regarding future performance.
- Mixed Market Signals: The current RSI of 47.78 suggests neutral territory, while the MACD indicates a potential bullish signal, reflecting complex market sentiment towards OSTX, necessitating investor vigilance.
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