Verve Therapeutics Shares Tumble After FDA Hold On Trial For Elevated Cholesterol Level Candidate

• The FDA has instituted a clinical hold on Verve Therapeutics Inc's (NASDAQ: VERV) 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.

• Related: Verve's Stock Price Could Continue To Rise Through Clinical Progress - Despite Worries About "DeeperPocketed" Competition.

• 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.

See more from Benzinga

• Amgen's Olpasiran Reduced Cholesterol Levels In 95% Of Patients In Mid-Stage Study

• Meta Goes Twitter Way With Layoffs, Twitter Might Want Some People Back After Firing Them, Coal Miners Terminate $6B Combination Discussions: Top Stories Monday, Nov. 07

• Bill Gates Once Described Trump As An Illeist: 'His First Sentence Kind Of Threw Me Off' - Microsoft (NAS

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.