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High materiality9/10

OS Therapies Gains FDA Type B Meeting and Cross-Agency OS Alignment

Jun 30, 2026, 7:44 AM EDT2 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Regulatory progress and cross‑agency alignment reduce execution risk and could accelerate market access; potential acceleration via OST-400 and BEST data supports upside, though outcomes depend on readouts and final approvals.

AI summary

What happened, with direct paths to the underlying reporting

OS Therapies reports a planned FDA Type B Meeting to review 2.5-year OS data and discuss 3-year OS as an approvable endpoint, aligning with MHRA/EMA. Biomarker data were submitted to the FDA BEST program; OST-400 recruiting progress could enable a synthetic control arm for Accelerated Approval. A joint FDA-EMA-MHRA coordination is under way, potentially enabling earlier market access.

  • FDA Type B Meeting requested to review OST-HER2 OS data and 3-year endpoint.
  • OST aligns with MHRA/EMA on 3-year OS as approvable endpoint.
  • Biomarker data submitted to FDA BEST program as surrogate efficacy data.
  • OST-400 recruitment progress; potential synthetic control arm for Accelerated Approval.
  • Rolling Review, RMAT, and BTD requests under review; joint dossier coordination.

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