BUZZ-IO Biotech drops after FDA recommends another late-stage study for cancer vaccine

Reuters
Sep 30
BUZZ-<a href="https://laohu8.com/S/IOBT">IO Biotech</a> drops after FDA recommends another late-stage study for cancer vaccine

** Shares of biotech firm IO Biotech IOBT.O fall 77.8% to 35 cents

** Company says the FDA has recommended IO Biotech to not submit an application based on data from the late-stage study and will need a second one

** In the late-stage study, the company was testing Cylembio in combination with Merck's MRK.N Keytruda for treating advanced skin cancer in which the results narrowly missed statistical significance

** IOBT plans to continue the dialogue with FDA to align on the design of a potential new study for Cylembio

** "While this is not the outcome we had hoped for, we respect FDA's feedback and remain confident in the therapeutic potential of Cylembio," said CEO Mai-Britt Zocca

** IOBT expects to incur a non-recurring charge of between $1 million and $1.5 million in Q3 2025 related to the restructuring, which includes around 50% reduction in full-time employees

** H.C. Wainwright expects the launch of Cylembio in 2029, rather than prior estimate of 2026

** Including session's move, stock down 61.8% YTD

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10