Rezolute's ersodetug Phase 3 sunRIZE misses primary endpoint in congenital hyperinsulinism; FDA review continues
核心洞察
Rezolute said the US Food and Drug Administration (搜索) is still reviewing data from a Phase 3 study of ersodetug in congenital hyperinsulinism (搜索).
The company disclosed the ongoing regulatory review on Wednesday, according to an MT Newswires report.
No timeline or outcome for the FDA's review of the Phase 3 ersodetug data was provided in the available report.
Rezolute (RZLT) said Wednesday that the US Food and Drug Administration (搜索) is still reviewing data from its Phase 3 study of ersodetug in congenital hyperinsulinism (搜索), according to an MT Newswires report.
The report did not specify a timeline for the review or indicate what the agency's next step might be. No further details on the Phase 3 dataset or the regulatory pathway were disclosed in the available article.