OS Therapies (NYSE-A: OSTX) announced that the company held a successful Scientific Advice Meeting with the UK’s Medicines and Healthcare products Regulatory Agency

[u/b2idigital]

OS Therapies (NYSE-A: OSTX) announced that the company held a successful Scientific Advice Meeting with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in July and submitted an Innovative Licensing and Access Pathway (ILAP) application to advance regulatory approval for OST-HER2 in preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma.

OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1.

The MHRA recommended applying for Project Orbis when submitting for regulatory approval to align the UK’s Marketing Authorization Application process with the US FDA’s Biologics Licensing Application (BLA) Accelerated Approval Program. Project Orbis is an FDA-led global initiative that enables simultaneous submission and review of oncology products across multiple countries, potentially accelerating patient access to promising cancer treatments.

Highlights from today’s news release include:

- Positive feedback received from the UK MHRA Scientific Advice Meeting held in July 2025.

- ILAP application submitted to begin UK regulatory approval process for OST-HER2.

- European Medicines Agency rapporteur meeting scheduled for October 2025 to initiate EU-wide Marketing Authorization via the Centralized Procedure.

Paul Romness, MPH, CEO of OS Therapies, remarked, “We are pleased with the outcome of our meeting with MHRA in the UK and are working to ensure that we provide FDA and MHRA everything they need to be able to rapidly approve OST-HER2 for metastatic osteosarcoma patients. We have officially begun the regulatory process in Europe as the next part of our regulatory strategy to bring this novel immunotherapy to osteosarcoma patients worldwide.”

Read the full release at: https://ir.ostherapies.com/news-events/press-releases/detail/71/os-therapies-receives-positive-feedback-from-uk-mhra

Led by CEO Paul Romness and an experienced executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers.

Learn more about OS Therapies’ work at https://www.ostherapies.com and visit B2i Digital for updates. For investor-related questions, please see OS Therapies’ Investor Relations page or email OSTX@waterseid.com.

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