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VRTX

Vertex

$177.40

2.38 (1.36%)

15:50
08/07/18
08/07
15:50
08/07/18
15:50

Vertex announces FDA approval of ORKAMBI to treat cystic fibrosis

Vertex announced the U.S. FDA has approved ORKAMBI to include use in children ages 2 through 5 years with cystic fibrosis who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population. ORKAMBI oral granules are available in two dosage strengths for weight-based dosing. ORKAMBI oral granules should be available for fulfillment within 2 to 4 weeks. ORKAMBI was already approved in the U.S. for the treatment of CF in patients ages 6 and older who have two copies of the F508del-CFTR mutation. A Marketing Authorization Application line extension for ORKAMBI in children ages 2 through 5 years has been submitted to the European Medicines Agency with a decision anticipated in the first half of 2019.

  • 30

    Aug

  • 31

    Aug

VRTX Vertex
$177.40

2.38 (1.36%)

07/26/18
OPCO
07/26/18
NO CHANGE
Target $200
OPCO
Outperform
Vertex price target raised to $200 from $180 at Oppenheimer
Oppenheimer analyst Hartaj Singh raised his price target for Vertex to $200 from $180 on "robust" Q2 results and accelerating pipeline. The analyst reiterates an Outperform rating on the shares.
07/26/18
BMOC
07/26/18
NO CHANGE
Target $204
BMOC
Outperform
Vertex price target raised to $204 from $191 at BMO Capital
BMO Capital analyst Do Kim raised his price target on Vertex to $204 and kept his Outperform rating after "stellar" Q2 results that "easily" beat consensus due to the strong Symdeko sales. The analyst notes that Symdeko appears to be "capturing Orkambi switchers as well as naive patients and Orkambi dropouts", adding that its updated revenue guidance is likely to prove conservative on Symdeko's expansion potential.
07/27/18
PIPR
07/27/18
NO CHANGE
Target $230
PIPR
Overweight
Piper says Vertex faces 'onerous task' getting reimbursement for Symkevi in EU
After the EMA announced earlier that the CHMP adopted a positive opinion on Symkevi, Piper Jaffray analyst Edward Tenthoff said he expects EMA approval within the next few months, after which Vertex will face the "onerous task" of gaining European reimbursement. The analyst, who anticipates KALYDECO and ORKAMBI label expansions with PDUFA dates in August to continue to drive CF sales growth this year, keeps his Overweight rating and $230 price target on Vertex shares.
08/07/18
STFL
08/07/18
INITIATION
Target $200
STFL
Buy
Vertex transferred with a Buy at Stifel
Stifel transferred coverage of Vertex to analyst Paul Matteis, who set a Buy rating and $200 price target on the shares. Matteis thinks Vertex continues to build strong barriers to entry that in Cystic Fibrosis and believes that the company's non-CF pipeline largely represents upside to the stock.

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