IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback

Published 29/09/2025, 22:30
IO Biotech stock rating downgraded to Hold by TD Cowen on FDA setback

Investing.com - 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. The stock, which has shown high volatility with a 71% year-to-date return, currently trades at $0.36.

The company is reducing its workforce by approximately 50% as it faces financial constraints, with cash reserves of approximately $38 million expected to last into the first quarter of 2026. According to InvestingPro data, while IOBT maintains more cash than debt on its balance sheet, the company is quickly burning through its reserves with negative free cash flow of -$83.4M.

Management plans to complete ongoing solid tumor and neoadjuvant/adjuvant basket trials, with data anticipated in the fourth quarter of 2025 or early 2026.

TD Cowen analyst Yaron Werber cited "a lack of late-stage catalysts" as a key reason for moving to the sidelines on the stock.

The firm will maintain its Hold rating pending further clarity on the outlook for Cylembio, IO Biotech’s cancer immunotherapy candidate.

In other recent news, IO Biotech has faced significant developments regarding its cancer vaccine candidate, Cylembio. The U.S. Food and Drug Administration (FDA) recommended against submitting a Biologics License Application (BLA) for Cylembio after the IOB-013 trial results showed improved progression-free survival but narrowly missed statistical significance. This recommendation 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. 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. Despite these setbacks, 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. These recent developments highlight the challenges and ongoing efforts in IO Biotech’s pursuit of advancing its cancer treatments.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.