Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that Health Canada has granted marketing authorization to its cystic fibrosis (CF) drug, Kalydeco (ivacaftor), for expanded use in children aged 12 months to two years with at least one of specified nine mutations in the CFTR gene.
Following this nod, Kalydeco becomes the first and the only approved medicine in Canada to treat the underlying cause of CF among such young patient population.
The approval was based on data from an ongoing phase III study, ARRIVAL, which evaluated children with one of the specified mutations in the CF transmembrane conductance regulator (CFTR) gene. The study demonstrated improvements in sweat chloride, a key secondary efficacy endpoint.
Kalydeco was approved by the FDA and the European Commission for same patient populations last August and November, respectively.
Shares of Vertex have gained 12.5% in the past year against the industry’s decline of 23.8%.
Kalydeco is a key revenue driver for Vertex. During the first nine months of 2018, the drug generated sales of $748 million, reflecting a 27.1% year-over-year increase, driven by continued label expansions and higher patient population.
Notably, CF is Vertex’s main area of focus. Apart from Kalydeco, its other two approved CF products are Orkambi and Symdeko, the constant revenue catalysts. Total CF product revenues were $2.2 billion in the first nine months of 2018, indicating a 46.7% surge year over year.
Evidently, Vertex’s CF pipeline is also quite strong. The company is investigating two next-generation CFTR correctors (VX-659 and VX-445) in phase III studies as part of a triple combination with tezacaftor and ivacaftor.
Studies on Vertex’s triple combination CF regimens are advancing fast. The CF triple-pill regimes are crucial for long-term growth as these have potential to treat at least 90% of CF patient population.
Zacks Rank & Stocks to Consider
Vertex currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include BioDelivery Sciences International, Inc. (BDSI - Free Report) , Merus N.V. (MRUS - Free Report) and ProQR Therapeutics N.V. (PRQR - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioDelivery Sciences’ loss per share estimates have been narrowed 20% for 2019 in the last 60 days. The stock has soared 79.6% in the past year.
Merus’ loss per share estimates have been narrowed 12.7% for 2019 in the last 60 days.
ProQR Therapeutics’ loss per share estimates have been narrowed 5.9% for 2019 over the past 60 days. The stock has skyrocketed 366.6% in a year.
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