Roth Capital analyst Adam Walsh has initiated coverage on OS Therapies with a Buy rating and announced a price target of $7. The rating highlights the firm's positive outlook on the company's stock performance.

Analyst Details

The coverage initiation comes from Adam Walsh, an analyst at Roth Capital. The Buy rating suggests that the stock is expected to outperform the market.

Price Target

Roth Capital has set a price target of $7 for OS Therapies. This target provides a benchmark for investors regarding the stock's potential value.

OS Therapies, Inc. (NYSE: OSTX) has accepted a new meeting request from the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) to review its pharmacodynamic response biomarker data for OST-HER2. This review is part of the FDA's Biomarker Qualification Program (BQP). The meeting is in addition to the previously scheduled Type B Statistical Methods meeting with the Center for Biologics Evaluation and Research (CBER), which will review 2.5-year overall survival data. CBER is the regulatory agency responsible for the approval decision on OST-HER2.

OS Therapies continues to expect the confirmatory Phase 3 clinical study for OST-HER2 to initiate near the end of the third quarter of 2026. The study will launch first in Australia, with expansion to the U.K., Europe, and the United States subject to early market access decisions. The European Medicines Agency (EMA) has set a submission window of September 30, 2026, for Conditional Marketing Authorisation Applications (CMAAs).

Regulatory alignment has been achieved with the EMA, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), and Australia's Therapeutic Goods Administration (TGA) on non-clinical, Chemistry, Manufacturing and Controls (CMC), and clinical safety requirements. The MHRA and TGA have agreed to allow the Phase 3 study to use the same OST-HER2 drug product batch from the Phase 2b trial. In the United States, the company has completed the submission of non-clinical and clinical Biologics License Application (BLA) modules as of January 2026.

The company has secured a $10 million line of credit supported by VAT reimbursements and R&D Tax Credits. A first draw of $1.6 million was received on July 2, 2026, with repayment due by April 2, 2027. OS Therapies holds $5.6 million in outstanding combined VAT and R&D Tax Credits, with an additional $4.6 million expected by year-end 2026. The company anticipates spending $1 million to open the Phase 3 program in Australia.

OS Animal Health, Inc. (OSAH) recently published peer-reviewed data indicating OST-HER2 combined with radiation improved survival in canine osteosarcoma. OSAH confidentially filed a registration statement on Form S-1 in January 2026 to support a 'go-public' strategy. The company plans to grant shares of OSAH to OS Therapies shareholders and launch a crowdfunding round following a regulatory meeting with the U.S. Department of Agriculture (USDA) in the summer of 2026.