Rezolute presents plans for ersodetug BLA filings in 2027
RZLT•Rezolute plans to file biologics license applications for ersodetug in congenital and tumor hyperinsulinism in 2027. Its Phase 3 sunRIZE trial missed its primary endpoint, while cash of approximately $180 million provides funding through 2028.
1. Filing plans and trial results
Rezolute outlined plans to file biologics license applications for ersodetug in congenital and tumor hyperinsulinism in 2027. The FDA encouraged a pre-filing meeting for congenital hyperinsulinism after reviewing additional study data. The Phase 3 sunRIZE trial missed its primary endpoint; the presentation attributed this to a confounding placebo effect from functional unblinding. At 10 mg/kg, time in hypoglycemia fell 32% versus placebo at week 24, but the result was not statistically significant (p=0.30). Rezolute said cash of approximately $180 million provides funding through 2028.
