Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval Program
Biomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026
UK and EU Marketing Authorisation Application (MAA) submissions for conditional approval expected by end of February 2026 and March 2026, respectively
Company expects to participate in multiple H1 2026 meetings with U.S. FDA, U.K. MHRA and Europe's EMA as part of processes to gain regulatory approvals
OS Animal Health 'go-public' transaction SEC filing expected in early January 2026
Delayed data from OST-504 Phase 1 trial in castration resistant prostate cancer expected in Q1 2026 after prioritizing biomarker lab partner resources for osteosarcoma data analysis, with End of Phase 1 FDA meeting expected in Q2 2026
Company plans to request End of Phase 2 meeting with FDA to review OST-503 non-small cell lung cancer frontline trial results in combination with Keytruda®
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.