On Wednesday, BTIG initiated coverage of biopharmaceutical company Rezolute , Inc. (NASDAQ:RZLT), assigning the stock a Buy rating and a price target of $13.00. The firm highlighted the company's significant year-to-date performance, which has seen its shares rise by 373%, compared to the 13% increase of the XBI biotech index.
Rezolute is currently addressing a partial clinical hold placed by the FDA on its Phase 3 study of RZ358 for congenital hyperinsulinism (cHI), referred to as the sunRIZE trial. Efforts include the submission of new safety data, with expectations that the FDA may lift the hold by September. This would enable pediatric enrollment in the United States and potentially indicate that the treatment's label could encompass pediatric patients.
The trial for RZ358, the sole treatment in development for all forms of hyperinsulinism, is progressing with patient recruitment outside of the U.S., and top-line data is anticipated by mid-2025. A Biologics License Application (BLA) submission is expected shortly thereafter, with projected peak sales of $1 billion and an 80% probability of success.
Additionally, management intends to advance RZ358 for tumor hyperinsulinism (HI), following a 100% success rate in an ongoing Expanded Access Program (EAP). The company plans to file an Investigational New Drug (IND) application later this summer, aiming to move directly into pivotal development.
Furthermore, Rezolute reported positive results from a Phase 2 trial of RZ402, an oral plasma kallikrein inhibitor for diabetic macular edema (DME), in May. The efficacy signal from the trial supports the potential of RZ402 as a first-in-class treatment for this widespread retinal disease.
In other recent news, biopharmaceutical company Rezolute, Inc. has been the subject of attention from investment firms Craig-Hallum and Jones Trading, both assigning a Buy rating to the company's stock.
Craig-Hallum set a price target of $14.00, based on the potential of Rezolute's lead drug candidate, RZ358, developed for congenital hyperinsulinism. Jones Trading, with a price target of $10.00, highlighted the possibility of label expansion for RZ358 to address hypoglycemia caused by certain rare tumors.
Rezolute's robust financial position, with a cash reserve of approximately $81.6 million, is expected to sustain the company's operations through critical upcoming clinical milestones. The company's lead candidate, RZ402, demonstrated promising results in Phase II trials for the treatment of diabetic macular edema.
The company's proactive engagement with the FDA and its strategy of considering partnerships to advance RZ402 into late-stage development have been noted. The Phase 3 sunRIZE trial of RZ358 is progressing outside the United States, with completion of enrollment expected by the end of 2024.
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