RealMoney Pro

As previously reported, Needham analyst Alan Carr upgraded Vertex to Buy from Hold ahead of the company's data on its cystic fibrosis triple regimen, as he predicts Vertex will identify at least one safe and effective triple regimen for commercial launch by the end of 2020. The analyst, who also said Vertex has a substantial lead and few competitors in the cystic fibrosis market, set a $155 price target on the stock.

Vertex Pharmaceuticals announced that the European Commission has granted approval for the label expansion of KALYDECO for the treatment of infants down to 1 month of age with cystic fibrosis who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. As a result of existing access agreements in Austria, Czech Republic, Denmark, Ireland, Norway, Sweden, and The Netherlands, eligible patients will have access to the expanded indication of KALYDECO shortly following regulatory approval by the European Commission. Vertex will continue to work with reimbursement authorities across the European Union to ensure access for all other eligible patients. In the U.K., following MHRA approval at the end of 2023, and as a result of the existing reimbursement agreement between Vertex and the National Health Service, eligible infants ages 1 month and older in the U.K. have access to this expanded indication for KALYDECO.