OS Therapies Initiates CMAA Process With UK MHRA For Herlystic In Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma; Expects To Complete CMAA Process Later In Q4 Of 2026
Benzinga Newsdesk 3 hours ago
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US Based Clinical Stage Oncology Company Begins Critical Step Following Successful September 2026 Scientific Advice MeetingSubmission expected to be accepted in the fourth quarter of 2026Potential early market access
US Based Clinical Stage Oncology Company Begins Critical Step Following Successful September 2026 Scientific Advice Meeting
- Submission expected to be accepted in the fourth quarter of 2026
- Potential early market access decision expected from MHRA in the first quarter of 2027
Grasonville, Maryland--(Newsfile Corp. - November 10, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has initiated a Conditional Marketing Authorisation Application (CMAA) process with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for Herlystic™ (OST-HER2) in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma. The Company expects to complete the CMAA process later in the fourth quarter of 2026.