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OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance

$OSTXPress releaseSep 2, 2026, 7:20 AM ETRead the release

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

Red flags4 · Pro

The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.

AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.

    OSTX: OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance — AI Analysis | Signal8