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OSTX: OST‑HER2 showed positive Phase 2b results; FDA/MHRA/EMA meetings set and BLA/CMAA filings targeted Q4 2026
OS Therapies says OST‑HER2's Phase 2b reported a clinically significant benefit on the 12‑month event‑free survival primary endpoint and an overall survival secondary endpoint, and it plans regulatory interactions (FDA Type C statistical meeting mid‑Sept 2026 plus MHRA/EMA meetings) before seeking Accelerated Approval BLA and Conditional Marketing Authorisation submissions in Q4 2026. The company expects RMAT/rolling review decisions to follow the FDA meeting, aims to file under accelerated/conditional pathways (with potential Priority Review Voucher eligibility if a U.S. BLA is granted), and plans a confirmatory Phase 3 CTA and final 3‑year OS data also in Q4 2026.
OSTX Q2: significant 2.5‐yr OS result; mid‐Sept FDA/MHRA statistic meetings and $5M first close of up to $10M financing
OS Therapies (OSTX) reported a Q2 net operating loss of $8.576M ($0.20/share) and says it raised minimally dilutive capital plus secured up to $10M of debt financing backed by U.K. VAT refunds and refundable R&D tax credits, with $5M funded at an Aug. 10 first close to extend runway into 2027. Clinically and regulatorily, OST‐HER2 showed a statistically significant 2.5‐year overall survival benefit (75% vs. 47%, p=0.003), the company has achieved multi‐agency alignment on 3‐year OS and biomarker endpoints and ATMP designation from EMA, and has Type C/Statistical Methods meetings with FDA and MHRA in mid‐September to lock the statistical analysis plan and confirmatory Phase 3 design ahead of BLA/CMAA submissions.
OSTX granted FDA Type C meeting to review 2.5‐year OS data for OST‐HER2; interim 3‐yr OS due early Sept
OS Therapies (OSTX) says the FDA granted a Type C Statistical Methods meeting to review 2.5‐year overall survival (OS) data from its Phase 2b OST‐HER2 trial in fully resected, pulmonary metastatic osteosarcoma; the meeting is expected mid‐September 2026. The company expects to announce interim 3‐year OS data in early September 2026, and outcomes of the meeting will inform comparator choice, RMAT designation, a possible FDA rolling review and timing for a BLA under Accelerated Approval by year‐end 2026. The firm also notes OS was sustained between the 2‐ and 2.5‐year timepoints and has a parallel MHRA statistical advice meeting scheduled in September.
OSTX accepts FDA meeting to review OST-HER2 biomarker data ahead of BLA
OS Therapies said it accepted a CDER meeting request to review its OST-HER2 pharmacodynamic biomarker data under FDA's BEST program, with the CDER meeting expected in summer 2026 and scheduled to run in parallel with a CBER Type B Statistical Methods meeting reviewing 2.5-year overall survival data. The company provided no new efficacy numbers here, reiterated plans to include final 3-year OS data in a BLA under the Accelerated Approval pathway (targeting late 2026), and noted PRV eligibility if a U.S. BLA is filed and approved.
OSTX says regulators aligned on OST-HER2 path; Phase 3 to start late Q3 2026 and FDA Type B meeting expected on 3-year OS use
OS Therapies (OSTX) said EMA, MHRA and TGA are aligned on requirements to support Conditional Marketing Authorisations for OST-HER2 and that a confirmatory Phase 3 will start in late Q3 2026 in Australia using the same drug-product batch as Phase 2b. The company has submitted non-clinical and clinical BLA modules to FDA, is awaiting a Type B Statistical Methods meeting to agree on using 3-year overall survival plus biomarkers for early U.S. approval, and secured a $10M VAT/R&D-backed line of credit that it says supports operations into 2027.
OSTX: OST-HER2 shows statistically significant 2.5‐yr OS benefit (75% vs 47%) in Phase 2b metastatic osteosarcoma
OS Therapies (OSTX) reported Phase 2b data showing OST-HER2 achieved a 2.5‐year overall survival of 75% vs a 47% pooled historical control (p=0.003) in fully resected pulmonary metastatic osteosarcoma, with no new patient deaths between years 2 and 2.5. The company is adding the data to regulatory dossiers, has EMA/TGA alignment that 3‐year OS (due early Q4‐2026) will be the key approvable endpoint, has upcoming FDA/MHRA meetings to seek alignment, and expects to start a confirmatory Phase 3 in late Q3‐2026 while pursuing accelerated/conditional authorizations in late 2026.