tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

FDA Recommends Against IO Biotech’s Cylembio Application

Story Highlights
FDA Recommends Against IO Biotech’s Cylembio Application

Elevate Your Investing Strategy:

  • Take advantage of TipRanks Premium at 55% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

IO Biotech ( (IOBT) ) has shared an announcement.

On September 25, 2025, IO Biotech‘s Board of Directors approved a restructuring plan to conserve capital, resulting in a 50% workforce reduction. This plan aims to align the company’s operations with its focus on advancing the development of Cylembio. The restructuring is expected to incur one-time charges of $1.0 to $1.5 million, primarily during the third quarter of 2025. On September 29, 2025, the company announced that the FDA recommended against submitting a Biologics License Application for Cylembio based on the IOB-013 trial data, as it narrowly missed statistical significance. IO Biotech plans to continue discussions with the FDA and European regulators to determine a path forward for Cylembio’s approval.

The most recent analyst rating on (IOBT) stock is a Buy with a $14.00 price target. To see the full list of analyst forecasts on IO Biotech stock, see the IOBT Stock Forecast page.

Spark’s Take on IOBT Stock

According to Spark, TipRanks’ AI Analyst, IOBT is a Neutral.

IO Biotech faces significant challenges due to its financial instability and lack of revenue. However, the progress in clinical trials and secured financing improve its future prospects, though it remains speculative. The technical analysis suggests neutral momentum, and the valuation highlights typical risks associated with biotech stocks awaiting commercialization.

To see Spark’s full report on IOBT stock, click here.

More about IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company focused on developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines using its T-win platform. The company is advancing its lead cancer vaccine candidate, Cylembio, in clinical trials and is headquartered in Copenhagen, Denmark, with US headquarters in New York, New York.

Average Trading Volume: 3,309,467

Technical Sentiment Signal: Buy

Current Market Cap: $104.1M

See more insights into IOBT stock on TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1