Rezolute clinical hold removal ‘best case scenario,’ says H.C. Wainwright

H.C. Wainwright says the FDA removal of the partial clinical holds on RZ358 is the “best case scenario” for Rezolute. The company plans to begin enrolling U.S. patients into sunRIZE by early 2025 with topline data still expected in the second half of next year, the analyst tells investors in a research note. The firm says management was optimistic about obtaining a priority review and expected to file the new drug application in Q2 of 2026 with a potential launch in 2027. In addition to the FDA recently clearing the investigational new drug application of RZ358 for treating hypoglycemia due to tumor hyperinsulinism, H.C. Wainwright views it as a positive sign that the agency recognizes the safety profile of RZ358. It keeps a Buy rating on Rezolute with a $14 price target.