PTX-252 / Pleco Therap, Hyloris Pharma - LARVOL DELTA

Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia (GlobeNewswire) - "Pleco Therapeutics...announces a positive outcome from its Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The meeting addressed the continued development of PTX-252, an intravenous (IV) formulation designed to treat patients with Acute Myeloid Leukaemia (AML)....The pre-IND meeting provided an opportunity for the Company to discuss its Investigational New Drug (IND) development plan and receive FDA guidance on nonclinical and clinical study requirements for its new drug candidate PTX-252."

FDA event • Acute Myelogenous Leukemia

Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML) (GlobeNewswire) - "Hyloris Pharmaceuticals SA...announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PTX-252 for the treatment of Acute Myeloid Leukaemia (AML). This product candidate, developed in collaboration with Pleco Therapeutics BV incorporates a novel molecular entity that is a derivative of a known established molecule and is designed to enhance the responsiveness of cancer cells to chemotherapy."

Orphan drug • Acute Myelogenous Leukemia