Rezolute Says It Had Encouraging FDA Meeting on Congenital Hyperinsulinism Drug Despite Missed Endpoint

Dow Jones03-24

By Nicholas G. Miller

Rezolute said the Food and Drug Administration encouraged it to submit study reports and analysis datasets for its ersodetug drug to treat congenital hyperinsulinism, despite its Phase 3 study missing its primary endpoint.

In a meeting with the FDA, Rezolute presented information to support its belief that the primary endpoint was confounded as a result of behavioral factors.

The company said the unblinded nature of self-monitored glucose, together with perceptions of treatment assignment, may have led to divergent behaviors between treatment groups during the study, which may have impacted the measurement of hypoglycemia.

The company said the FDA acknowledged the challenges posed by those behavioral factors.

The company said that after the FDA reviews study reports and analysis datasets it encouraged Rezolute to submit, it could determine whether there is enough evidence to support the submission of a marketing application or if additional information is required.

The company expects to have an update on the program in the second half of 2026.

Shares were up 2.1% to $2.45 in premarket trading.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

March 24, 2026 07:53 ET (11:53 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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Miller \n\n\n \n\n\n  Rezolute said the Food and Drug Administration encouraged it to submit study reports and analysis datasets for its ersodetug drug to treat congenital hyperinsulinism, despite its Phase 3 study missing its primary endpoint. \n\n\n  In a meeting with the FDA, Rezolute presented information to support its belief that the primary endpoint was confounded as a result of behavioral factors. \n\n\n  The company said the unblinded nature of self-monitored glucose, together with perceptions of treatment assignment, may have led to divergent behaviors between treatment groups during the study, which may have impacted the measurement of hypoglycemia. \n\n\n  The company said the FDA acknowledged the challenges posed by those behavioral factors. \n\n\n  The company said that after the FDA reviews study reports and analysis datasets it encouraged Rezolute to submit, it could determine whether there is enough evidence to support the submission of a marketing application or if additional information is required. \n\n\n  The company expects to have an update on the program in the second half of 2026. \n\n\n  Shares were up 2.1% to $2.45 in premarket trading. \n\n\n \n\n\n  Write to Nicholas G. 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