Vertex Shares Are Rallying: What You Need To Know

Vertex Pharmaceuticals Incorporated VRTX shares were off to a flying start Tuesday, extending the late-session surge from Monday that followed a positive FDA verdict.

From around $177 at 2:40 p.m. Monday, the stock rallied strongly into the close, ending the session at $183.53, slightly off the intraday high of $184.81. 

The momentum was continuing in Tuesday's session. 

What Happened

The FDA approved Vertex's Trikafta — a triplet comprising elexacaftor, tezacaftor and ivacaftor — for the treatment of cystic fibrosis in people ages 12 and older who have at least one F508del mutation in the CFTR gene, which is the most common cystic fibrosis-causing mutation.

Trikafta is Vertex' fourth approved cystic fibrosis drug.

Cystic fibrosis is an inherited disease that leads to the body producing thick and sticky mucus that can clog the lungs and the digestive system.

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Why It's Important

With the approval of Trikafta, about 6,000 cystic fibrosis patients ages 12 and older with one F508del mutation and one minimal function mutation have a treatment for their underlying causing of cystic fibrosis for the first time, according to Vertex. 

"After a 20-year journey together, we have received FDA approval of TRIKAFTA: a single breakthrough medicine with the potential to treat up to 90% of all people with CF in the future," said Jeffrey Leiden, the chairman, president and CEO of Vertex, said in a statement. 

The new combo regimen is priced at $311,000 per year, in line with Vertex' earlier cystic fibrosis drugs.

Vertex, which recently announced a deal to buy Semma Therapeutics, said it has a Marketing Authorization Application pending before the European Medicines Agency for the triplet regime.

Vertex is also evaluating the combo treatment in a late-stage study for the same indication in people ages 6-11. It is planning future studies for the pediatric population 6 years and younger. 

Vertex shares were up 3.73% at $190.84 at the time of publication. 

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