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Regulatory Momentum and De-Risked Path to Accelerated Approval Support Buy Rating on OST-HER2 Osteosarcoma Program

Regulatory Momentum and De-Risked Path to Accelerated Approval Support Buy Rating on OST-HER2 Osteosarcoma Program

OS Therapies Incorporated, the Healthcare sector company, was revisited by a Wall Street analyst yesterday. Analyst Jason McCarthy from Maxim Group maintained a Buy rating on the stock and has a $6.00 price target.

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Jason McCarthy has given his Buy rating due to a combination of factors tied to both clinical progress and regulatory momentum for OST-HER2 in osteosarcoma. He highlights the upcoming Type B pre-BLA meeting with the FDA in May as a pivotal catalyst, as it should clarify the adequacy of the Phase 2b data package and outline the confirmatory Phase 3 design needed to pursue accelerated approval.

He also notes management’s plan to submit a full BLA in the second quarter of 2026 and their goal of securing accelerated approvals in the U.S., EU, and UK in the second half of 2026, which could significantly derisk the program if achieved. Finally, he underscores the value of OST-HER2’s Orphan, Fast Track, and Rare Pediatric Disease designations, including potential monetization of a priority review voucher, alongside an extended cash runway supported by recent warrant exercises and an at-the-market facility, all of which strengthen the risk‑reward profile for OSTX shares.

In another report released today, Lake Street also maintained a Buy rating on the stock with a $14.00 price target.

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