Why Verve investors might hope for hold resolution soon

After recent FDA caution over novel gene-based approaches many are wondering how long it might take for the hold on Verve’s VERVE-101 to be lifted. An analysis published yesterday by Wells Fargo puts the median time to hold lift for gene-editing assets at 4.3 months, implying that Verve, whose IND was stymied in November, could see a resolution next month. The analysis looks at US gene and RNA therapy clinical holds since 2018, and calculates an overall median resolution time of 4.1 months, including 5.1 months for RNA approaches. The last stat will be of interest to investors in Avidity Biosciences, whose Marina study of the DM1 project AOC 1001 went on hold in September. Among all 53 holds identified the shortest, on Mustang’s MB-107, was resolved in just 28 days, while the longest, over Stoke Therapeutics’ Dravet project STK-001, is ongoing after nearly three years. Still, the analysts caution that Verve's hold could take more time to resolve than expected, given the specific FDA questions. These concerned potency differences between human and non-human cells, the risks of germline editing and off-target analyses in non-hepatocyte cell types, as well as a request to modify Verve’s trial protocol.

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