FDA recommends Type B pre‑BLA meeting for Rezolute’s ersodetug
The U.S. Food and Drug Administration advised Rezolute to hold a Type B pre‑BLA meeting for its investigational drug ersodetug, a step toward a possible Biologics License Application. The recommendation follows the agency’s review of data from the Phase 3 sunRIZE trial, which did not meet its primary or key secondary endpoints. Rezolute plans to incorporate upcoming Phase 3 upLIFT data into its BLA strategy.
Why it matters
The FDA’s encouragement lets Rezolute continue pursuing regulatory approval despite the sunRIZE study’s missed endpoints, keeping the program viable. The company expects to report topline results from the upLIFT study this quarter, which will shape its overall BLA submission plan. Shares rose 7.48% in pre‑market trading after the announcement.
Key facts
- 1The FDA recommended a Type B pre‑BLA meeting for ersodetug as a precursor to a potential BLA submission. rttnews.com
- 2The recommendation followed the FDA’s preliminary review of detailed data from the Phase 3 sunRIZE study. rttnews.com
- 3The sunRIZE study did not meet its prespecified primary endpoint or its key secondary endpoint. rttnews.com
- 4The FDA encouraged Rezolute to request a Type B pre‑BLA meeting despite the missed endpoints. rttnews.com
- 5Rezolute expects to report topline results from its Phase 3 upLIFT study this quarter. tradingview.com
- 6RZLT shares rose 7.48% in pre‑market trading after the FDA recommendation. rttnews.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.