Verve Therapeutics (VERV) Falls 11% on FDA Safety Concerns of Gene-Editing Approach
Verve Therapeutics (Nasdaq: VERV) took a hit today, falling almost 10.75% as the FDA has concerns about VERV’s gene-editing approach to high cholesterol. The FDA has placed Verve’s application to begin testing on humans in the U.S. on hold – the main concern being safety, particularly worries of genetic edits becoming inheritable and unintended effects of changing the gene responsible for high LDL cholesterol.
Verve has already began testing its drug on humans in New Zealand the U.K., but U.S. regulators are more cautious.
Verve intends to submit a response to the FDA as “expeditiously as possible” the Company has said in its filing and expects initial data from the Phase 1 study in New Zealand and the U.K. in the second half of 2023.
About Verve Therapeutics
Verve Therapeutics, Inc. (Nasdaq: VERV) is a clinical-stage genetic medicines company pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial two programs – VERVE-101 and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease, in order to durably reduce blood LDL-C levels. VERVE-101 is designed to permanently turn off the PCSK9 gene in the liver and is being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed in homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with ASCVD who have not achieved goal LDL-C with oral therapy and a PCSK9 inhibitor. For more information, please visit www.VerveTx.com