OS Therapies completes drug substance requalification for OST‑HER2, paving way for regulatory filings
OS Therapies announced that the drug substance used in its Phase 2b trial of OST‑HER2 has been requalified after ten years of storage. The milestone allows the company to start Conditional Marketing Authorisation applications in the U.K. and Europe and to support its Biologics License Application in the United States. The firm now expects the U.K. regulator’s decision in the first quarter of 2027 and the European decision in the first half of 2027, and says its recent capital raise and tax credits will fund operations through mid‑2027.
Why it matters
The requalification clears a key chemistry‑manufacturing‑controls hurdle, enabling OS Therapies to file for market approval in the U.K., Europe and the U.S. in Q4 2026, which could unlock future sales and a potential Priority Review Voucher. The company also notes that its recent funding is sufficient to sustain operations until mid‑2027, reducing short‑term financing risk.
Key facts
- 1The drug substance used in the Phase 2b trial of OST‑HER2 was requalified, confirming stability after ten years in storage. stocktitan.net
- 2OS Therapies will file Conditional Marketing Authorisation applications to the U.K. MHRA and the European Medicines Agency in the fourth quarter of 2026. nugget.ca
- 3The company now expects a regulatory decision from the MHRA in the first quarter of 2027 and from the EMA in the first half of 2027. stocktitan.net
- 4OST‑HER2 holds Orphan Drug, Fast Track and Rare Pediatric Disease designations from the U.S. FDA and Orphan Drug and ATMP designations from the EMA. nugget.ca
- 5Two Priority Review Voucher sales in October 2026 generated a total of $413 million (average $206.5 million). nugget.ca
- 6Recent capital raise and refundable R&D tax credit and VAT programs provide sufficient resources to fund operations through mid‑2027. stocktitan.net
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.