The FDA has instituted a clinical hold on Verve Therapeutics Inc’sVERV IND application to conduct a clinical trial evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia (HeFH).
VERVE-101 is currently being evaluated in the heart-1 Phase 1 clinical trial in New Zealand and the U.K.
Verve plans to provide updates pending engagement with the FDA and intends to work closely with the FDA to resolve the hold.
The company said that dosing in the first dose cohort of the heart-1 Clinical Trial of VERVE-101 in HeFH is complete.
Independent Data Safety monitoring board recommended proceeding to the second dose level in New Zealand and U.K.
Verve plans to report initial safety and pharmacodynamic data for all dose cohorts of the dose-escalation portion of the heart-1 study at a medical meeting in 2H of 2023.
The company ended Q3 with a cash balance of $550.7 million, sufficient to fund its current operating plan into 2H of 2025.
Price Action: VERV shares are down 30.70% at $21.67 on the last check Monday.
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok
