In early trading on the 24th, shares of Onconic Therapeutics hit the upper limit (the daily price increase cap).
It is seen as optimism after word spread that the company's next-generation synthetic lethality dual-target anticancer drug "Nesuparib" received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for small cell lung cancer (SCLC).
As of 9:28 a.m. that day, Onconic Therapeutics was trading at 25,450 won on the KOSDAQ market, up 5,870 won (29.98%) from the previous session.
Nesuparib received orphan drug designation from the FDA for pancreatic cancer in 2021 and for gastric cancer in 2025. Small cell lung cancer has now been added.
The FDA orphan drug designation is a program granted under the U.S. Orphan Drug Act after reviewing whether requirements are met, the medical basis for treatment potential, and the resulting need for development. Orphan drugs account for a large share—about half of the new drugs approved by the FDA—and they are granted seven years of exclusivity upon approval.