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OS Therapies Incorporated ( (OSTX) ) has issued an announcement.
On April 30, 2026, OS Therapies announced that the European Medicines Agency has begun a rolling review of its conditional marketing authorization application for OST-HER2 in preventing or delaying recurrence of fully resected pulmonary metastatic osteosarcoma. The company also disclosed alignment with European and Australian regulators on key efficacy endpoints, surrogate biomarker data, and non-clinical, safety and CMC packages, and it was selected for the EMA Raw Data Pilot Program and granted Advanced Therapy Medicinal Product status in the U.K.
Regulatory agencies in Europe and Australia agreed that three-year overall survival will be the primary efficacy endpoint for both conditional approvals and a global confirmatory Phase 3 trial expected to start in the third quarter of 2026, while two-year and 2.5-year survival data feed into the ongoing review. OS Therapies is pursuing coordinated market access and reimbursement discussions, expects a potential EMA decision on OST-HER2 in late 2026, and is leveraging its biomarker work to advance its OST-504 and KRAS-targeting OST-503 programs as it positions its platform within the growing immuno-oncology field.
The most recent analyst rating on (OSTX) stock is a Buy with a $14.00 price target. To see the full list of analyst forecasts on OS Therapies Incorporated stock, see the OSTX Stock Forecast page.
Spark’s Take on OSTX Stock
According to Spark, TipRanks’ AI Analyst, OSTX is a Neutral.
The score is held down primarily by weak financial performance (pre-revenue losses and intensified cash burn), partly offset by an improved debt-free balance sheet and recent funding events that support liquidity. Technicals are moderately supportive with price above key moving averages and positive momentum, while valuation is constrained by a negative P/E and no dividend yield.
To see Spark’s full report on OSTX stock, click here.
More about OS Therapies Incorporated
OS Therapies Inc., listed on the NYSE American as OSTX, is a biotechnology company focused on gene-edited, listeria-based cancer immunotherapies targeting rare pediatric and solid tumors. Its lead program, OST-HER2, is being developed for fully resected pulmonary metastatic osteosarcoma, alongside pipeline candidates OST-504 for castration-resistant prostate cancer and OST-503 for non-small cell lung and pancreatic cancers.
Average Trading Volume: 617,874
Technical Sentiment Signal: Sell
Current Market Cap: $68.52M
For an in-depth examination of OSTX stock, go to TipRanks’ Overview page.