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Vertex Pharmaceuticals VRTX announced that the European Commission (EC) has expanded the label of its blockbuster cystic fibrosis (CF) drug, Kaftrio, to treat all patients aged two years and older who have at least one non-class I mutation in the CFTR gene.
This approval was expected as the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending Kaftrio’s approval in February for the above indication. With this expanded label, nearly 4,000 more CF patients living in the region are now eligible for treatment with the drug.
Kaftrio is already approved for use in CF patients aged two years and older who have at least one F508del mutation in the CFTR gene.
The drug is marketed by Vertex for similar indications in the United States under the trade name Trikafta.
VRTX Stock’s Performance
Year to date, shares of Vertex have gained 18% against the industry’s 7% decline.
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Vertex’s Strong CF Portfolio
Vertex holds a dominant position in the CF market. It was the first company to successfully develop a drug that treats the underlying cause of CF. In addition to Trikafta/Kaftrio, the company markets four other CF medications — the recently approved Alyftrek, Symdeko/Symkevi, Orkambi and Kalydeco.
Vertex’s CF sales continue to grow, driven by Trikafta/Kaftrio, which added $10.24 billion in product sales in 2024. Sales of the drug were up about 15% year over year, driven by its continued robust performance across all markets.
The company aims to have small molecule treatments for most people with CF. In this regard, Vertex is developing an mRNA therapeutic, VX-522, in partnership with Moderna MRNA for approximately 5,000 people with CF who do not make CFTR protein and cannot benefit from its CFTR modulators. A single ascending dose (SAD) portion of a phase I/II clinical study on the Moderna-partnered therapy is complete, while a multiple ascending dose (MAD) portion of the study is ongoing. Data from this Moderna-partnered MAD study is expected in the first half of 2025.
VRTX’s Zacks Ranks
Vertex currently carries a Zacks Rank #3 (Hold).
Vertex Pharmaceuticals Incorporated Price
Vertex Pharmaceuticals Incorporated price | Vertex Pharmaceuticals Incorporated Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP and 89bio ETNB. While ANIP sports a Zacks Rank #1 (Strong Buy) at present, ETNB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period. Year to date, shares of ANIP have risen 21%.