Verve Therapeutics Gets FDA Fast-Track Designation for Verve-102

Published: 2025-04-11 08:24:07 ET VERV

By Colin Kellaher

Verve Therapeutics has won U.S. Food and Drug Administration fast-track designation for its Verve-102 gene-editing drug targeting a cholesterol driver of atherosclerosis.

Verve on Friday said the designation covers Verve-102 for the treatment of patient groups with hyperlipidemia and high lifetime cardiovascular risk to reduce low-density lipoprotein cholesterol, or LDL-C.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Verve said Verve-102, designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver and durably reduces LDL-C, is currently in a Phase 1b study to evaluate its safety and tolerability in adults with heterozygous familial hypercholesterolemia and/or premature coronary artery disease who require additional lowering of LDL-C.

The Boston clinical-stage genetic-medicines company in 2023 struck a deal with Eli Lilly that gave Lilly the right to opt-in to share 33% of worldwide development expenses of Verve's PCSK9 programs and to jointly commercialize and share profits and expenses related to commercialization in the U.S.

Verve on Friday said it remains on track to deliver the opt-in package for the PCSK9 program to Lilly in the second half of 2025.

Write to Colin Kellaher at [email protected]

(END) Dow Jones Newswires

04-11-25 0823ET