Verve's VERVE-102 Secures FDA's Fast Track Designation, Stock Up In Pre-Market

Verve Therapeutics

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(RTTNews) - Verve Therapeutics, Inc. (VERV), Friday announced that the company's investigational base editing medicine VERVE-102 has received the U.S. Food and Drug Administration's Fast Track designation for the treatment of patient groups with hyperlipidemia and high lifetime cardiovascular risk to reduce low-density lipoprotein cholesterol.

Currently, VERVE-102 is being tested in the Phase 1b Heart-2 clinical trial, evaluating the safety and tolerability of VERVE-102 administration in adult patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease who require additional lowering of LDL-C.

The company expects to announce the demographic and initial safety and efficacy data from the Heart-2 clinical trial in the second quarter of 2025.

Moreover, Verve plans to report the final data for the dose escalation portion of the Heart-2 clinical trial, deliver the opt-in package for the PCSK9 program to Eli Lilly and Company (Lilly), and initiate the Phase 2 clinical trial for the PCSK9 program in the second half of 2025.

In the pre-market hours, Verve's stock is trading at $3.25, up 6.55 percent on the Nasdaq.