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Near-term regulatory milestones (FDA Type C meeting, interim OS data, UK SAM) create concrete catalysts likely to drive upside; successful RMAT/Rolling Review could accelerate a BLA by year-end, potentially lifting OSTX shares. Past biotech de-risk events often trigger outsized moves, but delays or negative OS results could reverse quickly.
What happened, with direct paths to the underlying reporting
OS Therapies reports an FDA Type C statistical methods meeting for OST-HER2, with 2.5-year OS data due for review in Sept 2026, alongside UK MHRA SAM. Interim 3-year OS data is expected in early Sept 2026, potentially enabling RMAT designation and FDA Rolling Review, which could accelerate a BLA by year-end if efficacy holds.
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