OS Therapies Incorporated (NYSE:OSTX) shares are up during Tuesday’s premarket session as the company recently announced that its Phase 2b trial of OST-HER2 achieved statistically significant overall survival results at the 2.5-year mark.
OST-HER2 Shows Statistically Significant Survival Benefit
The trial results indicate a survival rate of 75% for patients treated with OST-HER2 compared to 47% in the historical control group, with a p-value of 0.003, in pulmonary metastatic osteosarcoma patients, a primary bone cancer metastasizes to the lungs
The topline data shows improving OST-HER2 survival benefit when compared with the 2-year data (2-year overall survival was 75% vs. 60%, p = 0.034).
No new patient deaths were reported between the 2 and 2.5-year timepoints in the OST-HER2-treated group.
OST-HER2 data is supported by a unique, patent-pending pharmacodynamic immune response biomarker signature that was developed as a surrogate clinical efficacy endpoint.
Data Expected To Support Upcoming Regulatory Discussions
This data is expected to support the company’s upcoming regulatory meetings with the FDA and other agencies regarding the drug’s approval.
The oncology company on Tuesday updated its U.S. and international regulatory submissions for OST-HER2 in metastatic osteosarcoma following new clinical efficacy findings, while preparing for a series of regulatory meetings aimed at securing alignment on approval pathways in major markets.
Europe and Australia Drug Regulators Align On Three-Year Survival Endpoint
The company said the European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) have already agreed that three-year overall survival data, expected in early fourth-quarter 2026, will serve as the primary clinical efficacy evidence supporting conditional Marketing Authorization Applications. A rolling review process is already underway in Europe.
In the U.S., OS Therapies is preparing for a Type B pre-Biologics License Application meeting with the Food and Drug Administration (FDA) to discuss using the upcoming three-year survival data as the basis for a Biologics License Application under the Accelerated Approval Program.
Additional Regulatory Meetings Planned
The company also plans to meet with the FDA in a Type C meeting and separately with the U.K. MHRA through a Scientific Advice Meeting in early June 2026.
OSTX Stock Price Activity: OS Therapies shares were up 8.29% at $2.03 during premarket trading on Tuesday, according to Benzinga Pro data.
Photo via Shutterstock
Login to comment