Verve Therapeutics, Inc. ( NASDAQ: VERV ) lost ~22% pre-market Monday after the genetic medicines company announced that the FDA has placed on hold its Investigational New Drug application (IND) for its gene editing candidate VERVE-101.
Submitting the IND in October, Verve ( VERV ) requested the U.S. regulatory clearance to run a clinical trial for VERVE-101 in patients with the cardiovascular disease heterozygous familial hypercholesterolemia ((HeFH))
However, on November 04, the FDA informed its decision to hold the IND application. The company is expected to receive an official letter with the regulator’s questions within 30 days.
VERVE-101 is currently undergoing a Phase 1 trial called heart-1 in New Zealand and the U.K., from which early initial data are expected in H2 2023.
The first dose cohort of the dose-escalation portion of heart-1 has completed dosing, and the three patients in the group have not indicated any treatment-related adverse events. The company has not included clinical data from the heart-1 trial in the IND package.
Verve ( VERV ) made the disclosure with its Q3 2022 results.
For further details see:
Verve sheds 22% as FDA holds trial application for gene editing drug