Rezolute Gets FDA Nod For Pre-BLA Meeting Despite Phase 3 Miss — Retail Expects ‘Huge Rerating’

The U.S. Food and Drug Administration recommended that the company request a Type B pre-BLA meeting for Ersodetug in congenital hyperinsulinism

• Rezolute’s Phase 3 sunRIZE study missed its primary and key secondary endpoints.
• FDA reviewed additional analysis, including glucose-monitoring data, before suggesting a pre-BLA meeting.
• The study’s open-label extension is still ongoing.

Rezolute (RZLT) was on investors’ radar in pre-market trading on Monday after the biotech firm received a positive regulatory update on its therapy for a rare genetic disorder of the pancreas, potentially taking it closer to official filing.

RZLT shares jumped more than 10% after the update but pared most of the gains as of this writing.

FDA Recommends Pre-BLA Meeting

The U.S. Food and Drug Administration (FDA) recommended that the company request a Type B pre-BLA meeting for Ersodetug in congenital hyperinsulinism. This is notable because Rezolute’s Phase 3 sunRIZE study failed to meet its primary and key secondary endpoints.

However, after reviewing additional analysis, including glucose-monitoring data, submitted by the company, the FDA recommended that Rezolute request a meeting that acts as a precursor to submitting a potential Biologics License Application (BLA) for drug commercialization. A pre-BLA meeting is a discussion on the planned filing and to identify any issues before submission.

The study’s open-label extension is still ongoing, with many patients continuing Ersodetug. Rezolute said that continued blood sugar control and reduced need for other standard treatments may suggest the drug provides lasting clinical benefit with longer-term use.

Rezolute Paused RZ402 Program To Focus On Ersodetug

Ersodetug is also being studied in the Phase 3 upLIFT trial for tumor hyperinsulinism, with topline results expected this quarter. Interim data released earlier this year showed six of the first eight patients met the study’s primary goal.

Rezolute is also evaluating Ersodetug for hypoglycemia following gastrointestinal surgery. Its earlier RZ402 program for diabetic macular edema (DME) was paused after Phase 2 trials as the company shifted resources toward Ersodetug.

Retail Calls FDA Decision A Big Win

Retail sentiment for RZLT on Stocktwits remained in the ‘bearish’ zone over the past 24 hours.

One user said the stock is set for a ‘huge rerating’

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Another user said it is a “big win, but the market doesn’t seem to agree.”

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The stock has surged more than 84% so far this year.

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