Rezolute To Initiate A Pivotal Phase 3 Study Of RZ358 in Participants 3 Months Of Age And Older With Congenital Hyperinsulinism
Portfolio Pulse from Happy Mohamed
Rezolute, Inc. (NASDAQ:RZLT) plans to initiate a pivotal Phase 3 clinical study of RZ358, its product candidate for congenital hyperinsulinism, in Europe and other geographies outside the US in Q4 2023, with topline results expected in 1H 2025. The study follows the successful Phase 2b RIZE study which demonstrated that RZ358 was safe, well-tolerated, and effective. However, due to FDA restrictions, it is infeasible to include the US in the study at this time.
June 27, 2023 | 8:07 pm
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Rezolute's initiation of a Phase 3 study for RZ358 could potentially boost investor confidence in the company's pipeline. However, FDA restrictions preventing the inclusion of the US in the study may limit the potential market for the drug.
The initiation of a Phase 3 study is a significant milestone in drug development, which could boost investor confidence in Rezolute's pipeline. However, the FDA restrictions preventing the inclusion of the US in the study could limit the potential market for the drug, which may temper investor enthusiasm.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 100