- Cantor Fitzgerald initiated coverage on Verve Therapeutics Inc VERV with a Neutral rating and a price target of $21.
- The analyst says Verve is a true pioneer in gene editing, planning to develop base editing medicines for HeFH and the prevention of ASCVD, both prevalent diseases with large potential markets.
- However, the analyst sees heightened regulatory and commercial risk compared to other gene-editing/ genetic medicines companies focused on rare diseases.
- The analyst believes it would be reasonable for the FDA to apply more regulatory scrutiny to a clinical candidate indicated for broad population segments, potentially extending development timelines with extended patient safety follow-up.
- In November 2022, FDA placed a hold on the IND application for the U.S. clinical trial of VERVE-101 in HeFH and requested additional preclinical data.
- Cantor says that these requests are not specific to VERVE-101 and will likely apply to all in vivo gene-editing programs in the U.S., noting that the FDA has not cleared an IND filing for any in vivo gene-editing trial in the U.S. to date.
- Price Action: VERV shares are down 7.82% at $20.97 on the last check Wednesday.
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