7/102 sources · 2 publishersUpdated Nov 10, 13:57 UTC
OS Therapies Opens UK Regulatory Filing for Herlystic
OS Therapies has started a UK Medicines and Healthcare products Regulatory Agency review for Herlystic, its OST-HER2 therapy, aimed at reducing relapse risk after complete surgery for lung-spread osteosarcoma. The company said on November 10, 2026 that it expects to finish the CMAA process in Q4 2026. It also identified a potential early MHRA market-access decision in Q1 2027.
Why it matters
The filing begins a UK regulatory pathway that could expand access to Herlystic if the agency grants authorization. OS Therapies expects a possible early market-access decision from the MHRA in Q1 2027.
Key facts
- 1OS Therapies initiated a Conditional Marketing Authorisation Application process with the UK MHRA for Herlystic in pulmonary metastatic osteosarcoma. finanznachrichten.de
- 2The company expects to complete the CMAA process in Q4 2026. finanznachrichten.de
- 3OS Therapies identified a potential early MHRA market-access decision in Q1 2027. finanznachrichten.de
- 4The filing followed a scientific advice meeting with the MHRA in September 2026. tradingview.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.