OS Therapies Discloses 2026 Timeline For Lead Drug Regulatory Filings

OS Therapies Incorporated (NYSE:OSTX) shares are up during Tuesday’s premarket session as the company is providing a global regulatory update regarding its OST-HER2 treatment for osteosarcoma, a kind of cancer that begins in the cells that form bones.

OS Therapies on Tuesday said it expects to complete conditional Marketing Authorization Application (MAA) submissions to both the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) by the end of the first quarter of 2026.

Additionally, the company is on track to submit the Clinical BLA module to the FDA following a Type D meeting anticipated in March 2026.

The company is also preparing to release additional biomarker data from its Human Metastatic Osteosarcoma Program in the first quarter of 2026, which aims to further characterize immune pathway activation and evaluate the relationship between biomarker expression and clinical outcomes.

This data is expected to support the use of these biomarkers as surrogate endpoints for clinical efficacy.

Additionally, the company was informed that Ayala Pharmaceuticals is dissolving.

The company acquired all listeria-based clinical, preclinical, and intellectual property assets from Ayala in April 2025, issuing to Ayala the equivalent of 4.8 million shares of OS Therapies common stock.

Ayala completed the liquidation of its OS Therapies shares and no longer holds any securities in the company.

Technical Analysis

The stock is currently trading 8.0% below its 20-day simple moving average (SMA) and 15.0% below its 100-day SMA, indicating some short-term weakness. Over the past 12 months, shares have decreased by 38.07%, and they are currently positioned closer to their 52-week lows than highs, reflecting ongoing challenges for the company.

The RSI is at a neutral level, suggesting that the stock is neither overbought nor oversold at this time. Meanwhile, MACD is also neutral, indicating a lack of strong directional momentum for the stock.

The combination of neutral RSI and MACD suggests mixed momentum, indicating that traders should be cautious as the stock navigates its current price levels.

• Key Resistance: $1.50
• Key Support: $1.12

Analyst Consensus & Recent Actions

The stock carries a Buy Rating with an average price target of $18.25. Recent analyst moves include:

• D. Boral Capital: Buy (Maintains Target to $20)

OSTX Price Action: OS Therapies shares were up 2.46% at $1.25 during premarket trading on Tuesday, according to Benzinga Pro data.

Photo by Aria Armoko via Shutterstock