Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration approved KALYDECO for use in children with cystic fibrosis ages 1 month to less than four months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical and/or in vitro assay data. KALYDECO is already approved in the U.S. and EU for the treatment of CF in patients ages four months and older. "Treating the underlying cause of cystic fibrosis as early as possible is important, and this approval, the first for a CFTR modulator in this age group, means families will now have a medicine for eligible infants," said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex.
Published first on TheFly
See the top stocks recommended by analysts >>
Read More on VRTX:
- Vertex Pharmaceuticals price target raised to $400 from $325 at Maxim
- Vertex Pharmaceuticals price target raised to $363 from $344 at Bernstein
- Vertex Pharmaceuticals price target raised to $315 from $299 at RBC Capital
- Vertex Pharmaceuticals price target raised to $456 from $341 at Truist
- Vertex Pharmaceuticals price target raised to $350 from $330 at TD Cowen