Being Cautious On Regulatory/Commercial Path, This Analyst Initiates Coverage On Verve Therapeutics

Cantor Fitzgerald initiated coverage on Verve Therapeutics Inc (NASDAQ: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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