As previously reported, Wedbush analyst Yun Zhong upgraded Rezolute to Outperform from Neutral with a price target of $5, up from $2, based on the update following a Type B meeting with the Food and Drug Administration to discuss the regulatory pathway for ersodetug in congenital hyperinsulinism. The FDA encouraged Rezolute to submit available data from both the randomized, double-blind, placebo-controlled portion of the pivotal Phase 3 sunRIZE study and the ongoing open-label extension portion for an independent evaluation by the FDA. Wedbush sees the FDA's feedback as showing the agency's recognition of both an unmet medical need in congenital HI and potential benefit that ersodetug can bring to patients. The firm has added the congenital HI program back to its valuation, although with a modest 30% probability of success and only revenue in the U.S.
