EC Approves Vertex’s Symkevi Combination Therapy For Cystic Fibrosis

The European Commission has approved Vertex Pharmaceuticals’ label extension for Symkevi with Kalydeco to include the treatment of cystic fibrosis in children aged 6 to 11 years.  

Vertex (VRTX) stated that the combination therapy of Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) was approved for patients aged 6 years and older who have “two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.”

The combination treatment will be immediately available to additional eligible patients in Germany. It will also be available shortly in countries that have long-term reimbursement agreements with Vertex, including the UK, Denmark and the Republic of Ireland. The company said that it will work closely with relevant European authorities to make this treatment available for eligible patients in all other countries as well. (See VRTX stock analysis on TipRanks)

Vertex’s CEO Reshma Kewalramani said, “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF.”

On Nov. 20, Bernstein analyst Vincent Chen initiated coverage of Vertex with a Buy rating and a price target of $275. Following an extensive study of the company’s cystic fibrosis franchise and pipeline programs, Chen believes the pipeline is underappreciated and offers substantial upside optionality.

In a research note to investors, the analyst stated, “We believe the odds of success are not as dismal as investors believe, we see near term catalysts that have potential to drive upside for the stock, and take a positive view on the stock.”

Overall, Vertex scores the Street’s Moderate Buy analyst consensus that breaks down into 13 Buys and 5 Holds. The average price target of $286.21 reflects an upside potential of 26.2% over the coming year. Shares have risen 3.5% year-to-date.

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Sirisha Bhogaraju
Sirisha Bhogaraju has over 14 years of experience in financial research. She has written in-depth research reports and covered news on companies across various sectors, with primary focus on the consumer sector. Sirisha has a master’s degree in finance.