Aptabio has been notified by the U.S. Food and Drug Administration (FDA) of the lifting of a Clinical Hold on the Phase 1 clinical trial for its oral drug candidate 'ABF-101.' Accordingly, the suspended clinical trial and dosing procedures are now set to fully resume.

According to Aptabio on the 16th, the FDA lifted the previously imposed clinical hold and delivered a 'Remove Clinical Hold' letter approving the resumption of the ABF-101 Phase 1 clinical trial. The company stated, "Following the receipt of the FDA letter, we plan to resume the suspended Phase 1 clinical trial and dosing."

The trial is a 'Phase 1 clinical trial of single and multiple ascending doses to evaluate the safety, tolerability, and pharmacokinetics of oral administration of ABF-101.' It is being conducted in healthy subjects and patients with age-related macular degeneration (AMD), and the plan is to precisely evaluate the drug's safety and in vivo pharmacokinetic properties through Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) methods.

The fact-finding date for this disclosure is June 16, 2026, which is based on the point at which the Contract Research Organization (CRO) received the Clinical Hold removal letter from the FDA. The date of this decision is June 12, 2026. Previously, Aptabio received a Clinical Hold letter from the FDA for the same clinical trial on February 23, 2026, which led to the suspension of its implementation.