[Featured Stock] Onconic Therapeutics Jumps 29% on News of FDA Orphan Drug Designation for Nesuparib

Onconic Therapeutics shares are surging nearly 29% following news that its anticancer drug candidate "Nesuparib" has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA).

As of 9:23 a.m. on the 24th, Onconic Therapeutics shares were trading at 25,450 won, up 5,870 won, or 29.98%, from the previous trading day.

On this day, Onconic Therapeutics announced that Nesuparib, its next-generation dual-target synthetic lethal anticancer drug candidate, has been granted Orphan Drug Designation by the FDA for small cell lung cancer (SCLC.

Nesuparib received Orphan Drug Designation from the FDA in 2021 for pancreatic cancer and last year for gastric cancer treatment. With this latest designation for small cell lung cancer, its potential as a pan-tumor anticancer therapy has once again been validated.

Small cell lung cancer is classified as a representative intractable cancer type due to its rapid proliferation, early metastasis, and high recurrence rate. After relapse following first-line treatment, therapeutic options are limited, and improving long-term survival rates remains an unresolved challenge, driving strong demand for therapies with novel mechanisms of action.

FDA orphan drugs are designated under the U.S. Orphan Drug Act after reviewing whether they meet the criteria, including medical evidence of therapeutic potential and the need for development. Orphan drugs account for about half of all FDA-approved new drugs, and, upon approval, they receive seven years of market exclusivity, making them a strategic asset in the global new drug development process.