Nyrada Inc (ASX:NYR)

Nyrada Inc. announced that it has received supportive written feedback from the US Food and Drug Administration following a pre-Investigational New Drug meeting request for Xolatryp®, its lead cardioprotection candidate aimed at reducing reperfusion injury in heart attack patients. The FDA reviewed the program’s chemistry, manufacturing and controls, nonclinical efficacy, safety, toxicology and clinical development materials, and indicated that Nyrada’s proposed development pathway for the PROTECT-MI Phase IIa study was broadly acceptable with no major issues identified. Specifically, the FDA said the completed nonclinical safety program appeared sufficient to support the Phase IIa study, agreed in principle with the intended STEMI patient population, accepted the proposed safety monitoring and endpoint framework, and confirmed that proceeding before a thorough QT/QTc study was acceptable based on Phase I cardiac safety data and planned ECG and telemetry monitoring. The FDA also considered the CMC testing scope appropriate, while requesting additional stability information and other details for the final IND submission, and noted that a future Fast Track Designation request could be reasonable if a Phase III trial evaluates serious clinical endpoints in STEMI. Nyrada said it remains on track to submit its US IND in the first half of calendar 2027 while continuing recruitment for the PROTECT-MI trial in parallel.