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VRTX

Vertex

$179.00

-6.46 (-3.48%)

07:57
10/19/18
10/19
07:57
10/19/18
07:57

Vertex receives European CHMP positive opinion for KALYDECO

Vertex Pharmaceuticals announces that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for KALYDECO to include the treatment of people with cystic fibrosis aged 12 to less than24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to less than24 months, who have specific mutations in the CFTR gene. The submission was supported by data from the ongoing Phase 3 open-label safety study of children with CF aged 12 to less than24 months who have one of 10 mutations in the CFTR gene that demonstrated a safety profile consistent with that observed in previous Phase 3 studies of older children and adults, and improvements in sweat chloride, a key secondary efficacy endpoint. Ivacaftor is already approved in Europe for the treatment of CF in patients aged two years and older who have one of the nine following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. It is also approved for the treatment of CF in patients aged 18 years and older who have an R117H mutation in the CFTR gene.

  • 22

    Oct

  • 24

    Oct

VRTX Vertex
$179.00

-6.46 (-3.48%)

10/01/18
CANT
10/01/18
INITIATION
Target $217
CANT
Overweight
Vertex initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young started Vertex Pharmaceuticals with an Overweight rating and $217 price target.
10/11/18
JEFF
10/11/18
NO CHANGE
Target $210
JEFF
Buy
Jefferies sees shares of Vertex 'going back up and recovering'
Shares of Vertex Pharmaceuticals (VRTX) have pulled back from recent highs of $190-$195 down to $175 on "risk-off rotation" amid the broader market selloff, Jefferies analyst Michael Yee tells investors in a research note. However, nothing fundamental has happened and Vertex still has the "cleanest growth story in large biotech," Yee contends. The triple pill has confirmed Phase III pivotal data coming Q4 and upcoming competitor Galapagos NV (GLPG) data "probably will eventually disappoint," claims the analyst. He also views CTX001 coming off clinical hold as a "nice positive" and thinks the company's pipeline is likely to start garnering more focus over the next 6-12 months. Yee sees the stock "eventually going back up and recovering" and keeps a Buy rating on Vertex with a $210 price target.
10/18/18
RBCM
10/18/18
UPGRADE
Target $9
RBCM
Outperform
Proteostasis upgraded to Outperform at RBC Capital on positive CF data
As reported earlier, RBC Capital analyst Brian Abrahams upgraded Proteostasis (PTI) to Outperform from Sector Perform and also raised his price target to $9 from $4 following an "impressive" set of data from its phase 2 cystic fibrosis doublet trial. The analyst notes that while it is too soon to determine if it will pose a "competitive threat to developmental CFTR modulators marketed by Vertex Pharma (VRTX), the trial showed "clean, consistent, dose-dependent lung function improvements".
10/18/18
MSCO
10/18/18
NO CHANGE
MSCO
Overweight
Vertex weakness on competitor data an overreaction, says Morgan Stanley
Morgan Stanley analyst Matthew Harrison attributes weakness in shares of Vertex (VRTX) to the fact that potential competitor Proteostasis (PTI) released initial Phase 1 data showing that its doublet achieved a roughly 6% increase in FEV1 in the highest dose, compared with about 5% for the VX-661 doublet in Phase 1/2. However, he would caution over-interpretation of the results, noting that Proteostasis' data includes only about five patients per arm; the high mean FEV1 increase may be the result of a "super-responder"; and doublet data "isn't meaningful given triplets with 10-15% FEV1 improvement will be the new standard of care." The analyst, who sees Vertex's sizeable lead and robust data limiting any competitive risks, keeps an Overweight rating on Vertex shares, which are down about 4% in morning trading.

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