By Colin Kellaher
Shares of Verve Therapeutics Inc. slid more than 15% on Monday after the genetic-medicines company reported details of the U.S. Food and Drug Administration's clinical hold on planned studies of its lead drug candidate.
The Cambridge, Mass., company, which is seeking FDA approval for a U.S. study of Verve-101, the cardiovascular disease heterozygous familial hypercholesterolemia, said the agency has requested additional preclinical data relating to potency differences between human and non-human cells, risks of germline editing, and off-target analyses in non-hepatocyte cell types.
Verve said the FDA also requested available data from an ongoing Phase 1 study in New Zealand and the U.K., and that the agency wants the company to modify the U.S. trial protocol to incorporate additional contraceptive measures and to increase the length of the staggering interval between dosing of participants.
Verve, which filed in October for FDA approval of the planned study, in early November said it received notification of the hold, and that it expected an official letter with the FDA's questions within 30 days.
Verve on Monday said it plans to submit a response to the FDA as expeditiously as possible, adding that it expects to report initial safety and pharmacodynamic data from the dose-escalation portion of the New Zealand/U.K. study in the second half of 2023.
Verve shares were recently changing hands at $20.05, down more than 16%.
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires