Shares of Verve Therapeutics (NASDAQ: VERV) plunged in morning trading on Monday after the company developing gene-editing medicine announced that the U.S. Food and Drug Administration (FDA) had placed a clinical hold. The FDA’s clinical hold was on its Investigational New Drug (IND) Application regarding VERVE-101 to conduct a clinical trial in the United States.
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The company is currently evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia, a type of cardiovascular disease in a heart-1 Phase 1 clinical trial in New Zealand and the United Kingdom.
The FDA has outlined certain information required to resolve the clinical hold. This includes ” additional preclinical data relating to: (i) potency differences between human and non-human cells, (ii) risks of germline editing, and (iii) off-target analyses in non-hepatocyte cell types.”
The FDA has also requested “available clinical data from the ongoing heart-1 trial” and has asked the company to include “additional contraceptive measures and to increase the length of the staggering interval between dosing of participants,” in the trial protocol in the U.S.
Wall Street analysts are, however, bullish about VERV stock with a Strong Buy consensus rating based on three Buys and one Hold.
