Sep. 3 at 2:40 PM
H.C. Wainwright reiterated
$RZLT Buy/
$14'
$ZLDPY $ZLDPF $CRNX $AMLX
H.C. Wainwright said: The FDA's greenlight on a streamlined Phase 3 upLIFT study-following granting two Breakthrough Therapy Designation (BTD) this year-is another sign of the agency recognizing the value of ersodetug in treating hyperinsulinism (HI), a rare disease.
We believe this FDA decision is in part based on the real-world evidence (RWE) of ersodetug in over 10 patients with tumor HI, consistent with the FDA guidance of integrating RWE in decision-making in rare diseases.
The revised upLIFT is a single-arm, open-label registrational study in up to 16 patients with tumor HI, as opposed to the originally proposed double-blind, randomized study in up to 48 patients.
We expect this to help with enrollment as doctors and patients greatly prefer that they're getting the drug rather than placebo. We reiterate our Buy rating and
$14 price target.
