Vertex Pharma’s New Cystic Fibrosis Drug Granted Approval By EU

Vertex Pharmaceuticals (VRTX) on Tuesday announced that the European Commission has granted approval for Alyftrek for the treatment of people with cystic fibrosis.

The approval is for the treatment of patients 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Vertex shares were trading around 1% higher at the time of writing.

Cystic fibrosis (CF) is a rare, life-shortening genetic disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands, and reproductive tract.

In individuals with cystic fibrosis, mutations in the CFTR gene result in a decreased quantity and/or impaired function of the CFTR protein channel at the cell surface. The defective function and/or absence of the CFTR protein result in poor flow of salt and water into and out of cells in several organs.

In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections, and progressive lung damage that eventually leads to death for many patients.

According to Vertex, it affects more than 109,000 people, including 94,000 people in North America, Europe, and Australia.

In head-to-head clinical trials, Alyftrek, a once-daily triple combination therapy of vanzacaftor, tezacaftor, and deutivacaftor, was found to be superior to the company’s older cystic fibrosis medicine, Kaftrio, also known as Trikafta, in reducing sweat chloride, demonstrating greater improvement in CFTR function.

Vertex said on Tuesday that eligible patients in Ireland, Denmark, and Germany will have access to Alyftrek shortly after receiving regulatory approval from the commission.

The drug is already approved in the U.S. and the U.K. In the first quarter of 2025, the company incurred $53.9 million in revenue from the drug.

On Stocktwits, retail sentiment around Vertex is unmoved within ‘bearish’ territory over the past 24 hours, while message volume is consistently at ‘high’ levels.

The stock is up by about 12% this year but down by 4% over the past 12 months.

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