OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing
OS Therapies (OSTX) announced full alignment with UK MHRA and EU EMA for its Conditional Marketing Authorisation Application (CMAA) for OST-HER2. The company expects to submit the CMAA soon and begin a confirmatory Phase 3 trial in Q4 2026. OST-HER2 has received multiple designations from the FDA and EMA, including Orphan Drug and Fast Track.

