Aldoxorubicin

LadRx plans to pursue FDA approval for aldoxorubicin through the 505(b)(2) pathway, potentially accelerating market entry without additional human clinical studies by leveraging doxorubicin data. The company regained control of aldoxorubicin in June 2024 after terminating its NantCell license agreement. LadRx aims to request a pre-NDA meeting with the FDA mid-2025, subject to additional funding. Aldoxorubicin delivers 3.5-4 times greater doses of doxorubicin without significant heart muscle effects, even at doses exceeding 5,000 mg/m2. The company has received a $1 million milestone payment related to arimoclomol and is evaluating various funding pathways.