Rezolute, Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $423.6M
- Price
- $4.38
- % Change (Daily % change from the live per-ticker quote feed.)
- +1.39%
- Volume
- 1.7M
About
Rezolute, Inc., a late-stage rare disease company, focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism in the United States. Its lead clinical asset is ersodetug, an intravenously administered human monoclonal antibody that is in Phase 3 clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder, as well as for the treatment of hypoglycemia; and clinical trials of ersodetug for tumor hyperinsulinism. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was founded in 2010 and is headquartered in Redwood City, California.
Quick stats
Shares outstanding96.7M
Computed float95.4M
Float / shares98.7%
Cash runway (months)17.3
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001509261
Websitehttps://www.rezolutebio.com
AI Summary
AI-generated1/16
standardmixedregulatory
Rezolute Announces FDA Recommendation to Hold a Pre-BLA Meeting as a Precursor to Submitting a Biologics License Application (BLA) for Congenital Hyperinsulinism
Rezolute announced the FDA recommended a pre-BLA meeting for ersodetug in congenital hyperinsulinism following a preliminary review of detailed Phase 3 sunRIZE data.
SunRIZE missed its prespecified primary endpoint (hypoglycemia reduction by finger-stick SMBG) and key secondary endpoint, but FDA acknowledged SMBG limitations and reviewed CGM analyses showing clinically relevant improvements before encouraging the BLA pathway.
FDA explicitly did not opine on approvability; Rezolute will finalize its BLA strategy after topline results from the upLIFT tumor-HI study, expected this quarter.
The open-label extension continues with high retention, nine months to over two years of ersodetug exposure, and reduced use of standard-of-care therapies.
Red flags
- sunRIZE missed both the prespecified primary and key secondary endpoints
- FDA did not opine on approvability and may require a new randomized controlled trial, which would delay or impair the congenital HI program