Mar. 10 at 11:56 AM
$OSTX Major catalysts approaching.
The FDA elevated OST-HER2’s meeting from Type D to a Type B Pre-BLA meeting, signaling discussions are now focused on the Accelerated Approval pathway as the company completes its rolling BLA.
Near-term catalysts:
• Clinical BLA module submission expected by end of March
• FDA Pre-BLA meeting to finalize the approval path
• Overseas regulatory updates
• Progress on OST-503 & OST-504 pipeline programs
• OSAH spinoff expected to unlock additional platform value
OST-HER2 also qualifies for a Rare Pediatric Disease Priority Review Voucher, and the program is extended through 2029. These vouchers have historically sold for
$100M–
$200M+, which is significant relative to OSTX’s current market cap.
Clear regulatory timeline + multiple catalysts ahead. The kicker is, the most valuable asset they have is next in line for development OST-503. If the lead drug gains approval it could unlock a pathway for an asset worth 10X the current candidate. 📈📈📈📈📈
