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Vertex's (VRTX) Trikafta NDA Gets Priority Review by FDA

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Zacks Equity Research
·3 min read
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Vertex Pharmaceuticals Inc. VRTX announced that the FDA has accepted its supplemental new drug application (sNDA) for the label expansion of its triple combination therapy, Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor). The company is seeking to expand the label of Trikafta to include children aged 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data.

The FDA has granted priority review to the sNDA and set an action date of Jun 8, 2021.

Shares of the company have increased 2.4% in the past year compared with the industry’s growth of 16.3%.

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

We note that Trikafta is the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. The drug is presently approved in the United States for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene.

The company plans to submit a marketing authorization application (MAA) variation for Trikafta in the European Union in the first half of 2021 for children aged 6 through 11.

Sales of Trikafta in the first nine months of 2020 were about $2,773 million, representing about 60% of the total product revenues. Thus, the drug is an important revenue contributor for the company. A potential approval of Trikafta for pediatric patients in the United States and Europe could bring additional revenues for Vertex.

Zacks Rank & Other Stocks to Consider

Vertex currently carries a Zacks Rank #2 (Buy).

Some other similar-ranked stocks in the healthcare sector include Anavex Life Sciences Corp. AVXL, Acorda Therapeutics Inc. ACOR and Alexion Pharmaceuticals Inc. ALXN. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Anavex’s ’loss per share estimates have narrowed from 48 cents to 46 cents for 2021 over the past 60 days. Shares of the company have increased 104.4% in the past year.

Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.

Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 over the past 60 days. Shares of the company have increased 51.2% in the past year.

Vertex Pharmaceuticals Incorporated Price

Vertex Pharmaceuticals Incorporated Price
Vertex Pharmaceuticals Incorporated Price

Vertex Pharmaceuticals Incorporated price | Vertex Pharmaceuticals Incorporated Quote

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