As previously reported, H.C. Wainwright downgraded IO Biotech (IOBT) to Neutral from Buy with no price target after the company gave an update from its pre-BLA meeting with the FDA and reported that the agency does not recommend that the company submit a BLA for Cylembio. Given the company’s cash position, the company would either need to raise additional capital, partner, or license out Cylembio to advance the new Phase 3 trial, says the analyst, who downgrades the shares based on the shift from a near-term regulatory review to planning a new large pivotal trial.
TipRanks Cyber Monday Sale
- Claim 60% off TipRanks Premium for data-backed insights and research tools you need to invest with confidence.
- Subscribe to TipRanks' Smart Investor Picks and see our data in action through our high-performing model portfolio - now also 60% off
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on IOBT:
- FDA Recommends Against IO Biotech’s Cylembio Application
- IO Biotech says FDA reccomends not submitting BLA based on IOB-013 trial data
- IO Biotech implements plan to conserve capital, 50% reduction in full-time staff
- IO Biotech Reports Q2 2025 Financial Results
- IO Biotech’s Cylembio Shows Promise Despite Missed Endpoint, Buy Rating Affirmed