[Themed Stocks] Aptabio, despite the U.S. FDA approval of the Phase II modification of 'APX-115', closed flat.

Aptar Bio received approval from the U.S. Food and Drug Administration (FDA) for the change in the Phase II clinical trial plan of the imaging agent-induced acute kidney injury (CI-AKI) treatment drug ‘APX-115’ (Isuzinaxib), but the stock price slightly declined.

According to data from the Korea Exchange, Aptar Bio closed at 7,020 Korean won, down 10 won or 0.14% from the previous trading day. Although the company announced the FDA approval for the change in the clinical trial plan during the trading session, it did not immediately trigger a surge in the stock price.

According to the company’s announcement, this Phase II clinical trial aims to evaluate the efficacy and safety of APX-115 in patients undergoing percutaneous coronary intervention (PCI). The trial will be conducted at 14 hospitals in Korea and the United States, using a multi-national, multi-center, randomized, double-blind design, with a total of 230 subjects planned for recruitment.

The core focus is on administering APX-115 orally for five days to PCI patients and assessing its safety compared to a placebo. The company stated that it plans to monitor adverse reactions, blood and urine tests, and electrocardiogram changes over 12 weeks. The clinical trial period runs from the date of the change approval until December 31, 2026.

Investors are paying attention to this announcement because the FDA accepted the change in the clinical trial design. This is often interpreted as a sign that the global clinical trial process is likely to proceed as planned. However, the Phase II trial is still in the stage of validating efficacy and safety, and the company also indicated that the probability of the candidate drug ultimately receiving drug approval is about 10%.

Previously, APX-115 received FDA approval for Phase II clinical trials in 2023. Aptar Bio is also developing this candidate drug in the field of diabetic nephropathy. This change approval can be seen as a follow-up step to continue the global clinical development of its existing pipeline.

Aptar Bio was founded in 2009 and went public through a special listing on the NASDAQ market in 2019. The company is advancing new drug development based on core platform technologies centered on oxidative stress regulation and other mechanisms.