Rezolute Receives FDA Recommendation for Pre-BLA Meeting
Rezolute has been recommended by the FDA to hold a Pre-Biologics License Application (BLA) meeting. This meeting is a precursor to submitting a BLA for its treatment for congenital hyperinsulinism. The agency reaffirmed its commitment to addressing the unmet medical needs for congenital and tumor-related hyperinsulinism. Rezolute is also on track to report topline results for its Phase 3 upLIFT study in tumor HI this quarter.
The Agency reiterated its commitment to addressing the unmet need for treatment of congenital and tumor-related hyperinsulinism and to serving these patient communities. Rezolute said it remains on track to report topline results for the Phase 3 upLIFT study in tumor HI this quarter. , Oct. 05, 2026 (GLOBE…