On October 23, regulators at the Food and Drug Administration (FDA) cleared a key obstacle for Verve Therapeutics (NASDAQ: VERV), giving it the green light to proceed with an early-stage clinical trial in the U.S. to investigate one of its gene-editing therapy candidates currently known as VERVE-101. The pre-revenue biotech now has the opportunity to prove to the world that its platform is capable of curing rare inherited illnesses by correcting patients' genes. 

But doing initial clinical trials in the U.S. is still a long way from commercializing a product and becoming a self-sustaining business, and many other challenges remain. Could the FDA's decision make this stock worth buying today for certain investors, or is it too early to bite? 

To start, let's contextualize what the business is trying to do and why the FDA's decision matters. VERVE-101 is Verve's most advanced pipeline program, and it's intended to treat or cure heterozygous familial hypercholesterolemia (HeFH), a hereditary heart disease that affects roughly three million people in the U.S. and the E.U. HeFH causes patients to accumulate unhealthy levels of LDL cholesterol (LDL-C), which leads to clogged arteries, heart attacks, and strokes.

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Source Fool.com