IO Biotech: TD Cowen Downgrades Hold from Buy Rating.

IO Biotech: TD Cowen Downgrades Hold from Buy Rating.

Investing.com reports that TD Cowen has downgraded IO Biotech (NASDAQ:IOBT) from Buy to Hold following the FDA’s recommendation against filing a Biologics License Application (BLA) for Cylembio combined with pembrolizumab in melanoma IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1]. The stock, which has shown high volatility with a 71% year-to-date return, currently trades at $0.36.

The FDA's recommendation has led to a significant setback for IO Biotech, which is facing financial constraints. The company is reducing its workforce by approximately 50% and expects its cash reserves of approximately $38 million to last into the first quarter of 2026 IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1]. Despite maintaining more cash than debt on its balance sheet, IOBT is burning through its reserves with negative free cash flow of -$83.4M IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1].

Management plans to complete ongoing solid tumor and neoadjuvant/adjuvant basket trials, with data anticipated in the fourth quarter of 2025 or early 2026 IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1]. However, TD Cowen analyst Yaron Werber cited "a lack of late-stage catalysts" as a key reason for the downgrade IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1].

Recent developments have also affected IO Biotech's cancer vaccine candidate, Cylembio. The FDA recommended against submitting a BLA for Cylembio after the IOB-013 trial results showed improved progression-free survival but narrowly missed statistical significance IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1]. This has led to H.C. Wainwright downgrading IO Biotech from Buy to Neutral, citing a delay in Cylembio’s potential launch timeline to 2029 due to the need for an additional Phase 3 trial IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1]. Morgan Stanley also adjusted its outlook by lowering the price target for IO Biotech to $4.00 from $6.00, while maintaining an Overweight rating IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1].

Despite these challenges, IO Biotech will present data from its Phase 3 trial of the IO102-IO103 vaccine combined with pembrolizumab for advanced melanoma at the European Society for Medical Oncology Congress. The presentation has been selected as a late-breaking abstract, indicating the research’s potential impact on clinical practice IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback^[1].