Vertex Gets EU Nod for New Cystic Fibrosis Drug Alyftrek

Vertex Pharmaceuticals VRTX announced that the European Commission has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for treating people with cystic fibrosis (“CF”) aged six years and above having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (“CFTR”) gene.

Alyftrek is a combination of three drugs — vanzacaftor (a CFTR potentiator), deutivacaftor (a CFTR corrector) and tezacaftor.

The approval in the European Union was expected as the European Medical Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending approval of Alyftrek for people with CF aged six years and older in April.

Vertex’s fifth CFTR modulator therapy, Alyftrek (vanza triple), is a next-in-class triple combination regimen that was approved by the FDA in December 2024 for treating people with CF aged six years and older. The medicine was approved in the United Kingdom in March.

Regulatory filings seeking approval of Alyftrek are currently under review in Canada, Switzerland, Australia and New Zealand.

VRTX's Stock Performance

Year to date, shares of Vertex have risen 12.3% against the industry’s decline of 3.4%.

Alyftrek, a Key Product in VRTX's CF Portfolio

Vertex holds a dominant position in the CF market. Its CF sales continue to grow, driven by the demand growth of the blockbuster drug, Trikafta/Kaftrio, in younger age groups. While in the near term, expansion to younger age groups should continue to drive CF sales growth, the launch of Alyftrek is expected to drive growth in the medium term.

Per management, Alyftrek has the potential to provide better patient benefits than Trikafta and become a new standard-of-care treatment in CF. It can possibly treat CF patients who have discontinued Trikafta or other Vertex CF medicines. The drug might also improve dosing (once daily), lower the royalty burden and extend patent protection from 2037 for Trikafta into 2039 for Alyftrek.

In two head-to-head studies, once-daily Alyftrek demonstrated non-inferiority to twice-daily Trikafta in combination with ivacaftor in improving ppFEV1 and showed superior reduction in sweat chloride levels, indicating greater improvement in CFTR function.

Despite the promising outlook, Alyftrek sales have been slower than expected in its first quarter of launch. During the first quarter of 2025, Alyftrek generated sales of $53.9 million. Management expects Alyftrek sales to pick up in the second half of 2025, as the majority of patients in the United States who are currently on Trikafta are expected to switch to Alyftrek.

Vertex is also evaluating Alyftrek in children with CF aged between two and five years.

VRTX's Zacks Rank & Stocks to Consider

Vertex currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Exelixis EXEL, Spero Therapeutics SPRO and Puma Biotechnology PBYI, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.64 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.85 to $3.13. Year to date, shares of EXEL have rallied 31%.

EXEL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 48.60%.

In the past 60 days, estimates for Spero Therapeutics’ loss per share have narrowed from $2.32 to $1.43 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.98 to $1.15. Year to date, shares of SPRO have surged 181.6%.

SPRO’s earnings beat estimates in two of the trailing four quarters, while missing the same in the remaining two occasions, the average surprise being 8.29%.

In the past 60 days, estimates for Puma Biotechnology’s earnings per share have increased from 60 cents to 65 cents for 2025. During the same time, earnings per share estimates for 2026 have risen from 48 cents to 51 cents. Year to date, shares of PBYI have gained 17.7%.

PBYI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 171.43%.

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This article originally published on Zacks Investment Research (zacks.com).

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