OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance
OS Therapies laid out a dense regulatory calendar for OST-HER2 in metastatic osteosarcoma: interim 3-year overall survival data plus an FDA Type C Statistical Methods meeting and an MHRA Statistical Methods Scientific Advice meeting are all expected in September 2026. RMAT and Rolling Review decisions are expected to follow the FDA meeting, with final 3-year overall survival data, a Pre-BLA meeting, a U.S. BLA submission under the Accelerated Approval Program, and CMAA submissions in Europe, the U.K., and Australia slated for Q4 2026.
Key figures
- Prv sale date
- August 2026
- Prv sale amount
- $220 million
- Platform investment
- $300 million
- Interim os data timing
- September 2026
- Bla cmaa submission timing
- Q4 2026
- Platform investment duration
- over 20 years
- First commercial product timing
- 2027
AI analysis
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