OS Therapies Bone Cancer Trial Data Strengthens FDA Case

OS Therapies Incorporated (NYSE:OSTX) shares are down on Thursday following the announcement of positive biomarker data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, a type of bone cancer. OST-HER2, the company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein OSTX Clinical Trial Data Signals Regulatory Approval Path The company reported that activation of immune blood biomarkers in the interferon gamma pathway distinguished long-term survivors from short-term survivors in their clinical trial. This data strengthens their pending Biologics License Application (BLA) submission with the U.S. Food and Drug Administration (FDA), with regulatory approval targeted for the U.K. by the end of the second quarter of 2026, the U.S. by the third quarter of 2026, and Europe by the end of 2026. Under the Rare Pediatric Disease Designation program, if the company receives Accelerated Approval before September 30, 2026, it will become eligible to receive a Priority Review Voucher that it intends to sell. OSTX Shows Bearish Momentum Below Key SMAs Currently, the stock is trading 2.5% below its 20-day simple moving average (SMA) and 12.8% below its 50-day SMA, indicating bearish momentum. Over the past 12 months, shares decreased approximately 66.17%. Currently, they’re closer to their 52-week lows than highs. The RSI is at 47.78, which is considered neutral territory, suggesting that the stock is neither overbought nor oversold. Meanwhile, MACD is above its signal line, indicating a potential bullish signal. The combination of neutral RSI and bullish MACD suggests mixed momentum for the stock. Key Resistance: $1.69 Key Support: $1.12 Benzinga Edge Scores OSTX Market Position Below is the Benzinga Edge scorecard for OS Therapies Incorporated (OSTX), highlighting its strengths and weaknesses compared to the broader market: Momentum: Neutral (Score: N/A) — The stock is currently showing mixed signals. Quality: Weak (Score: N/A) — The company may face challenges in maintaining quality metrics. Value: Risk (Score: N/A) — The stock appears to be trading at a premium relative to its peers. The Verdict: OS Therapies Incorporated’s Benzinga Edge signal reveals a challenging environment as the company navigates its clinical trials and market expectations. Investors should remain cautious, especially given the current performance metrics and the stock’s position in the market. OSTX Price Action: OS Therapies shares were down 4.52% at $1.48 at the time of publication on Thursday, according to Benzinga Pro data. Image: Shutterstock