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The FDA Has Temporarily Halted the Approval of a Gene Editing Medicine Intended to Reduce Levels of Elevated Cholesterol, Dampening Enthusiasm for the Company Verve!

After an FDA clinical hold, Verve Therapeutics‘ main gene-editing candidate has lost some steam.

The company’s third-quarter earnings report, which came out Monday, says that work on Phase 1 for VERVE-101 in the heart-1 trial for people with a type of genetically high cholesterol has been put on hold. Verve didn’t say what the FDA was worried about, but they did say they were told about the hold on Friday, Nov. 4. Within 30 days, the agency is expected to give more information.

VERVE-101 is meant to turn off the PCSK9 gene in the liver to lower low-density lipoprotein cholesterol in people with heterozygous familial hypercholesterolemia (HeFH), a type of atherosclerotic cardiovascular disease. Gene editing therapy is different from CRISPR therapies because it does not cut DNA. Instead, it changes one base, or letter, in the genome to a different one.

People with HeFH have a change in a gene in their liver that makes their cholesterol levels very high and often causes them to have heart attacks or strokes at a young age.

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The company asked the FDA to start testing on people in October. Verve has promised to work quickly to solve the problem once they get the letter from the FDA explaining the hold.

In the meantime, the heart-1 trial is still going on in New Zealand and the UK, where the initial dose-escalation part of the study is done. According to Verve, this first dose was well tolerated by all three patients, and no treatment-related side effects were reported. However, there were grade 1 side effects seen. The company didn’t say what kind of bad things happened.

The trial’s independent data safety monitoring board has recommended increasing the dose to the second dose level, which Verve says will start soon. In the second half of 2023, the first data should be shown at a medical meeting.

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As of September 30, Verve had $550,7 million in cash, cash equivalents, and securities that could be sold. This is enough to keep going until the second half of 2025. This is compared to the $360.4 million that was on hand at the end of 2021.

This is because a partnership with Vertex brought in $60 million and the sale of common stock brought in $247.5 million in net proceeds during the quarter.

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The company is also getting ready to ask for permission to test VERVE-201 on people. This is a therapy for homozygous familial hypercholesterolemia, which is a form of high cholesterol that is caused by genes.

Verve’s stock fell almost 25% from Friday’s closing price of $31.29 to Monday’s premarket trading price of $23.74 per share.

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