By Rob Curran
OS Therapies shares jumped after the company said the Food and Drug Administration has agreed to a meeting to discuss the status of a bone cancer treatment candidate.
Shares of OS Therapies rose 19% to $1.78 in premarket trading Tuesday.
The company seeks to gain alignment with the regulator on the surrogate endpoint to support breakthrough therapy designation and accelerated approval of OST-HER2 in the prevention of recurrence of Osteosarcoma, or a type of bone cancer, that had spread to the lungs and had been surgically removed.
The FDA granted a written response-only meeting, and the development-stage biopharmaceutical company anticipates the regulatory agency's response by mid-June 2025.
New York-based OS Therapies plans to make a presentation on its treatment at a conference on June 28.
"We remain on track for an early third quarter submission and are hopeful to receive approval by year-end 2025 in order to bring this life saving treatment to patients in early 2026," said Chief Executive Paul Romness.
The drug candidate has received a rare pediatric disease designation for osteosarcoma from the FDA.
OS Therapies said if it receives a conditional biologics license application through accelerated review before Sept. 30, 2026, it will become eligible to receive a priority review voucher that it intends to immediately sell.
Write to Rob Curran at rob.curran@dowjones.com
(END) Dow Jones Newswires
April 22, 2025 08:24 ET (12:24 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
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.