OS Therapies Gains EMA Rolling Review, TGA Endpoint Alignment and $9.25M Funding
Stonegate Capital Partners notes that EMA has initiated a rolling review of OST-HER2’s Conditional Marketing Authorization dossier while Australia’s TGA and EMA have agreed on 3-year overall survival as the critical efficacy endpoint. The firm highlights seroconversion biomarker data as surrogate evidence and a $5.25 M raise plus $4 M non-dilutive funding to back a dense 2026 catalyst calendar.
1. Regulatory Advancement
EMA has begun a rolling review of the OST-HER2 Conditional Marketing Authorization dossier, marking a pivotal step toward formal approval. Australia’s TGA has aligned with EMA on 3-year overall survival as the approvable efficacy endpoint, and MHRA has granted ATMP designation, collectively shaping a global approval pathway.
2. 2026 Catalyst Calendar
OS Therapies expects to report 2.5-year overall survival data in mid-2Q26, hold FDA and MHRA meetings in 2Q26, initiate its Phase 3 trial in Australia in 3Q26, present 3-year OS results in early 4Q26, and potentially secure an EMA CMA decision in 4Q26.
3. Financing and Valuation Levers
The company secured a $5.25 M financing round and anticipates $4 M in non-dilutive funding to bridge the regulatory window. A potential priority review voucher at a $205 M transaction value remains a significant approval-contingent valuation lever.