BTIG Starts Rezolute (RZLT) at Buy

BTIG analyst Julian Harrison initiates coverage on Rezolute (NASDAQ: RZLT) with a Buy rating and a price target of $13.00.

The analyst comments "RZLT has been a strong outperformer YTD (+373% vs. +13% XBI) and we continue to see an attractive disconnect between three shots on goal and where RZLT currently trades. Efforts to address an FDA-implemented partial clinical hold on the ongoing Phase 3 study of RZ358 in congenital hyperinsulinism (cHI) (sunRIZE) are underway, with new safety data and renewed determination. We think there is a good chance the FDA capitulates (discussed in greater detail below), which could allow pediatric enrollment in the US if the partial hold is lifted by September, and more importantly, signal that RZ358’s eventual label could include pediatric patients. The trial continues to recruit patients outside the US with topline data expected in mid-2025, followed by BLA submission soon after (we estimate $1B in peak sales, 80% probability of success). RZ358 is the only Tx we are aware of that is being developed for all forms of hyperinsulinism. On that point, mgmt. also plans to advance RZ358 in tumor hyperinsulinism (HI) based on a 100% (5/5) success rate from an ongoing EAP program. Tumor HI could more than triple RZ358’s TAM – an IND for the program is expected to be filed later this summer, with the intention of proceeding directly into pivotal development. Finally, results from the Phase 2 trial of RZ402 (oral plasma kallikrein inhibitor) for diabetic macular edema (DME) surprised to the upside in May, with an efficacy signal supporting a first-in-class and -category approach to treating this large retinal disease that we expect to be highly receptive to innovative Tx options. Initiating at BUY and a $13 PT."

For an analyst ratings summary and ratings history on Rezolute click here. For more ratings news on Rezolute click here.

Shares of Rezolute closed at $4.78 yesterday.

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