- Trial Phase
- Phase 2b (completed) — preparing for regulatory submissions (BLA/CMAA)
- Time to Market
- If approved via MHRA Conditional Marketing Authorization, potential UK launch in H1 2027. US BLA submission is planned for Q4 2026 with FDA review likely extending into 2027-2028.
- Why 8/10
- The next hard binary catalyst is the MHRA Conditional Marketing Authorization Application (CMAA) decision on Herlystic, expected in Q4 2026 (within ~2 months). As the company's sole late-stage asset at a clinical-stage biotech with no approved products, this decision is make-or-break for the stock, warranting an impact score of 8.
Watch for the MHRA CMAA decision on Herlystic in Q4 2026 — this is the single most important binary catalyst for OSTX. The stock trades near its 52-week low ($1.25) with a mean analyst target of $8.50, implying massive upside if approved, but the company has no approved products and limited cash runway. Monitor the warrant inducement offer closing (Oct 30, 2026) and the registration statement filing for New Warrant Shares (due Nov 30, 2026) for dilution signals.
Price Chart
Executive Summary
Herlystic (daznelimgene lisbac, also known as OST-HER2) is OS Therapies Inc's (NYSE: OSTX) lead asset — a gene-therapy cancer vaccine targeting HER2-positive osteosarcoma, a rare pediatric bone cancer. The company is preparing regulatory submissions in Q4 2026 across multiple jurisdictions (BLA to FDA, CMAA to MHRA/UK, plus EMA and TGA), with a potential MHRA decision expected in Q4 2026 as the next major binary catalyst. OSTX trades at ~$1.25 (near its 52-week low) with a market cap around $58M, while analyst consensus is heavily bullish (9 Buy/Strong Buy, 1 Hold) with a mean price target of $8.50. The company raised ~$7.2M via a warrant inducement in October 2026 and has $7M in accrued UK R&D tax credits, but remains a pre-revenue clinical-stage biotech with no approved products and significant dilution overhang from outstanding warrants.
How It Works
Herlystic (daznelimgene lisbac) is a gene-therapy-based cancer vaccine designed to train the immune system to recognize and attack cancer cells that express the HER2 protein. Osteosarcoma, a rare bone cancer primarily affecting children and young adults, often overexpresses HER2. The therapy is administered to stimulate a targeted immune response against HER2-positive tumor cells, potentially preventing recurrence after standard treatment.
Trial Status
OS Therapies has completed Phase 2b clinical development for Herlystic in osteosarcoma and is preparing regulatory submissions: a Biologics License Application (BLA) to the FDA, a Conditional Marketing Authorization Application (CMAA) to the UK's MHRA, plus submissions to the EMA and TGA, all targeted for Q4 2026. The company has appointed a Chief Commercial Officer to lead U.S., U.K., and European launch planning.
The Two-Sided Case
Upcoming Catalysts
- MHRA CMAA submission and potential decision on Herlystic in Q4 2026
- FDA BLA submission planned for Q4 2026
- Warrant inducement offer closing deadline: October 30, 2026
- Registration statement filing for New Warrant Shares due by November 30, 2026
- Expected receipt of ~$7M in UK R&D tax credits in early 2027
- OSTX Q3 2026 earnings report scheduled for November 13, 2026
Source Filing
The SecBot filing or press-release report that triggered this drug report:
OS Therapies Inc 8-K OSTX ·Originating report