OS Therapies Advanced OST-HER2 Regulatory Pathway
The company secured FDA alignment on Phase 3 study designs while coordinating with the U.K. MHRA.
Updated on Sept. 21, 2026 in Cancer
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OS Therapies has completed a Type C Statistical Methods Meeting with the FDA, securing agreement on an amended Phase 3 study design for its therapy, OST-HER2. The company will utilize the U.K. MHRA as its lead regulatory agency under the international Project Orbis framework.
Why it matters
The alignment with regulatory bodies is intended to de-risk the global market access process for OST-HER2. By utilizing Project Orbis, OS Therapies aims to synchronize the regulatory pathway between the U.S. and the U.K. to facilitate faster delivery of the treatment.
Since 2021, 29 products led by the MHRA have received FDA approval via Project Orbis. Meanwhile, OS Therapies recently completed a Priority Review Voucher sale in August 2026 valued at $220 million.
The players
OS Therapies
This biotechnology company is focused on developing treatments for cancer and is currently based in Rockville, Maryland, and New York, New York.
FDA
The U.S. Food and Drug Administration is the federal agency responsible for regulating food, tobacco, and medical products.
MHRA
The Medicines and Healthcare products Regulatory Agency is the United Kingdom's executive agency responsible for regulating medicines and medical devices.
The details
OS Therapies is building a natural history database incorporating U.K. national patient registry data to support its clinical goals. The company confirmed that a patient previously listed as lost to follow-up is currently alive, and it expects to submit a Conditional Marketing Authorisation Application in the U.K. shortly.
Timeline
May 2019 marked the launch of the Project Orbis initiative.
Project Orbis-led FDA approvals began in 2021.
A Priority Review Voucher was sold for $220 million in August 2026.
This update was published on September 21, 2026.
The company plans to initiate a U.K. Phase 3 trial in mid Q4 2026.
The Big Picture
This strategy follows a pattern set by Project Orbis, an international program established to synchronize the review of cancer drugs across global regulatory agencies. It shifts the development trajectory by moving away from isolated national applications toward a harmonized global access model.
This regulatory progress establishes a clearer path for potential access to OST-HER2 for patients in both the U.S. and the U.K. It represents a shift in how medical treatments are evaluated for global populations rather than limited regional approvals.
The takeaway
The move demonstrates the increasing importance of cross-border regulatory cooperation in speeding up the development of cancer therapies. By utilizing existing data frameworks like the U.K. Clinical Practice Research Datalink, companies can improve the efficiency of their clinical trial pipelines.
What happens next
OS Therapies expects to initiate a Phase 3 trial in the U.K. in mid Q4 2026 and plans to have a commercial-ready drug product available in 2027.
Further reading
For more on international oncology developments, visit the Cancer section.
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