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June 4, 2014
08:01 EDTVRTXVertex reports improvement in lung function in proof-of-concept ivacaftor study
Vertex Pharmaceuticals announced the results of a two-part proof-of-concept study of ivacaftor in 24 people with cystic fibrosis who have a residual function mutation. The first part of the study evaluated ivacaftor, compared with placebo, in a two-week crossover design over two treatment cycles, and the second part of the study evaluated ivacaftor in an eight-week open-label design. In part one, a statistically significant improvement in mean absolute lung function was observed after treatment with ivacaftor for two weeks compared with placebo. In part two of the study, improvements in lung function were observed after eight weeks of treatment. In the study, ivacaftor was generally well-tolerated, and the most common adverse events in the treatment group were cough and respiratory tract infection. This proof-of-concept study was the first to evaluate the use of ivacaftor in multiple residual function mutations and is supported by in vitro observations that showed ivacaftor enhanced the function of the cystic fibrosis transmembrane conductance regulator protein in cells with residual function mutations. Based on these data, Vertex plans to initiate a larger Phase 3 study in people with residual function mutations that will evaluate longer-duration treatment with ivacaftor, pending discussions with regulatory authorities.
News For VRTX From The Last 14 Days
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November 23, 2015
08:34 EDTVRTXVertex names Michael J. Parini EVP, chief legal officer
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November 20, 2015
10:34 EDTVRTXVertex approval in Europe to bring gradual uptake, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff says Vertex Pharmaceuticals must now gain reimbursement in each individual country after the European Union approved Orkambi as expected. The approval will ultimately add around 12,000 homozygous F508del cystic fibrosis patients appropriate for the drug, but uptake will be gradual and dependent on the pace of reimbursement. He reiterates an Overweight rating on Vertex with a $180 price target.
05:36 EDTVRTXVertex receives EU approval for Orkambi
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November 18, 2015
05:41 EDTVRTXVertex receives 2 EU approvals for Kalydeco
Vertex Pharmaceuticals announced that the European Commission has approved expansion of the indication for Kalydeco to include children ages 2 to 5 with cystic fibrosis, or CF, who have one of nine gating mutations in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene and to include people with CF ages 18 and older who have an R117H mutation. Ivacaftor was previously approved in the European Union, or EU, for use in people with CF ages 6 and older who have one of nine gating mutations. In Europe, approximately 125 children with CF ages 2 to 5 have one of the nine gating mutations included in today's approval and approximately 350 adults with CF have an R117H mutation. Vertex will now begin the country-by-country reimbursement approval processes for each new indication.
November 16, 2015
07:16 EDTVRTXHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).

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