May. 28 at 7:47 PM
BTIG reiterated
$RZLT at Buy-
$15 and said, "Enrollment in sunRIZE has completed with 62 participants enrolled (original target n=56), leaving data disclosure on track for December 2025. An estimated 15% of patients were enrolled from US sites and are expected to be included in the final dataset.
Ersodetug has received Breakthrough Therapy Designation (BTD) for cHI (as well as tumor HI) which we view as an encouraging acknowledgment from the FDA of ersodetug's potential.
Following topline sunRIZE data, mgmt. expects BLA filing for ersodetug in cHI in mid-2026.
Given both primary and secondary efficacy endpoints in sunRIZE were previously included in Phase 2b RIZE and met with statistical significance in the pooled analysis (reviewed in our
$RZLT initiation), we see high odds of a successful data outcome from sunRIZE in December 2025."
BTIG additionally said:
