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)
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