Analyst Jason McCarthy of Maxim Group maintained a Buy rating on OS Therapies Incorporated, retaining the price target of $6.00.
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Jason McCarthy has given his Buy rating due to a combination of factors that highlight the promising outlook for OS Therapies Incorporated. The recent Type C meeting with the FDA was notably positive, supporting the potential for accelerated approval based on the survival data from their single-arm study in osteosarcoma. This meeting confirmed that the existing data, when combined with upcoming biomarker data, could pave the way for a Biologics License Application under the Accelerated Approval Pathway.
Furthermore, the OST-HER2 program, which targets HER2-expressing cancer cells, holds multiple FDA designations such as Orphan, Fast Track, and Rare Pediatric Disease, enhancing its potential for a priority review voucher. The company’s plan to release biomarker data at the upcoming JPM Healthcare Conference positions them strategically for filing. Additionally, the FDA’s guidance on a confirmatory study, which could expand the label to other osteosarcoma settings, aligns well with the company’s regulatory strategy, further supporting McCarthy’s optimistic outlook.
In another report released today, Lake Street also maintained a Buy rating on the stock with a $17.00 price target.