OST-HER2 — Regulatory decision
2026
The Company also anticipates receiving Conditional Marketing Authorisation Applications from the U.K.'s Medicines and Healthcare products Regulatory Agency and the EMA for OST-HER2 in 2026.Source filing
OSTX biotech catalysts & pipeline
OS THERAPIES INC · Data as of 2026-10-25
Upcoming catalysts
Herlystic™ (OST-HER2; daznelimgene lisbac) — NDA/BLA submission
Q4 2026
The Company reiterates its intention to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval Program (Accelerated Approval) and Conditional Marketing Authorisation Applications (CMAAs) to the U.K. Medicines and Healthcare products Regulatory Authority (MHRA), the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) in the fourth quarter of 2026.Source filing
OST-HER2 — Interim data
Oct 2026
We also anticipate releasing additional biomarker data in October 2026 to further characterize immune pathway activation and its relationship to clinical outcomes.Source filing
OST-HER2 — Regulatory decision
Q4 2026
The Company anticipates a potential CMA decision by EMA in the fourth quarter of 2026.Source filing
OST-HER2 — NDA/BLA submission
Q1 2027
We anticipate submitting the clinical Biologics License Application (BLA) module following an expected Type C meeting with the FDA in the September 2026 and completing conditional Marketing Authorization Application (MAA) submissions to both the MHRA and the EMA in the first quarter of 2027.Source filing