Key Developments: Vertex Pharmaceuticals Inc (VRTX.O)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Vertex Pharmaceuticals Inc Reiterates FY 2013 Revenue Guidance
Vertex Pharmaceuticals Inc reiterated financial guidance for fiscal 2013 total revenues to be in the range of $1.10 billion to $1.25 billion. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $1.17 billion for fiscal 2013. Full Article
Vertex Pharmaceuticals Inc's ALS-2200 (VX-135) Study Shows Reduction In HCV RNA In People With Genotype 1 Hepatitis C Virus Infection And Cirrhosis, and People With Genotypes 2, 3 or 4 HCV Infection
Vertex Pharmaceuticals Inc announced new data from a viral kinetic study of the uridine nucleotide analogue ALS-2200 (VX-135) in development for the treatment of hepatitis C. There was a median 4.08 log10 reduction in hepatitis C virus (HCV) RNA after seven days of dosing with 200 mg once daily in treatment-naïve people with genotype 1 chronic HCV infection and compensated cirrhosis. Among treatment-naïve people with genotypes 3 or 4 chronic HCV infection, there was a median 4.65 log10 reduction in HCV RNA after seven days of dosing with 200 mg once daily. Prior to a protocol amendment, one treatment-naïve person with genotype 2 HCV infection received 100 mg of ALS-2200 once daily for seven days, and had a 5.04 log10 reduction in HCV RNA after seven days of dosing. ALS-2200 was well-tolerated in this study, there were no serious adverse events and no patients discontinued due to adverse events. These new data are consistent with previously reported data in people with genotype 1 chronic HCV infection, and will be presented the 48th Annual Meeting of the European Association for the Study of the Liver (EASL) in Amsterdam, Netherlands, April 24 to 28, 2013 (poster #866). These data support Vertex`s recently announced non-exclusive agreement with Bristol-Myers Squibb Company to conduct Phase 2 studies of once-daily all-oral treatment regimens containing VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C. Full Article
Vertex Pharmaceuticals Inc Revises FY 2013 Revenue Guidance-Conference Call
Vertex Pharmaceuticals Inc announced that it has provided guidance for fiscal 2013 around revenues back in January that stated the revenues were guided to about $1.1 billion to $1.25 billion. Full Article
Vertex Pharmaceuticals Inc Issues FY 2013 Revenue Guidance In Line With Analysts' Estimates
Vertex Pharmaceuticals Inc announced that for fiscal 2013, it expects total revenues to be in the range of $1.10 billion to $1.25 billion, including full year 2013 KALYDECO net revenues of $280 million to $320 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $1.14 billion for fiscal 2013. Full Article
Morgan & Morgan Announces Investigation Of Vertex Pharmaceuticals Inc
Morgan & Morgan announced that it is investigating into whether certain officers and directors of Vertex Pharmaceuticals Inc breached their fiduciary duties to VRTX shareholders in connection with Vertex's recent public acknowledgement that it made inaccurate disclosures about the Phase 2 clinical studies of VX-909 and Kalydeco, two experimental drugs in clinical trials. On May 7, 2012, Vertex issued a press release claiming that patients who received VX-909 and Kalydeco during a phase 2 clinical trial showed improvement in their lung functions. Published reports state that between May 7, 2012 and May 25, 2012, certain Vertex officers and directors sold over $22 million of their personally owned shares. On May 29, 2012, Vertex acknowledged publicly that the results from its clinical trials were not as positive as previously indicated. On June 27, 2012 Vertex admitted that the May 7th statements were simply inaccurate. Vertex's stock price declined significantly on the news. Full Article
Data from Vertex Pharmaceuticals, Inc.'s Viral Kinetic Study Shows Rapid Reduction of HCV RNA with ALS-2200 (VX-135)
Vertex Pharmaceuticals Inc announced that data on ALS-2200 (VX-135), an oral medicine Vertex is developing for the treatment of hepatitis C, are being presented for the first time at The Liver Meeting, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). There was a median 4.54 log10 reduction (range -3.81, -5.08) in hepatitis C virus (HCV) RNA after seven days of dosing with ALS-2200 (200 mg) once daily in people with genotype 1 chronic hepatitis C who were new to treatment (n=8). Similar reductions in HCV RNA were seen in a seven-day viral kinetic study of once daily ALS-2200 (200 mg) in combination with ribavirin (n=8). ALS-2200 was well-tolerated in this study, with no serious adverse events and no discontinuations due to adverse events. Based on these data, and to further characterize the medicine’s safety and efficacy profile, Vertex plans to begin multiple Phase 2 studies of 12-week all-oral regimens in people with genotype 1 hepatitis C in early 2013, pending discussions with regulatory authorities. These studies will include combinations of VX-135 with GSK2336805 and separately with simeprevir (TMC435). Upon the start of Phase 2 studies, ALS-2200 will be known as VX-135. Screening in the first study, which will evaluate VX-135 in combination with ribavirin, is expected to begin in the coming weeks. Full Article
Levi & Korsinsky, LLP Announces Class Action Against Vertex Pharmaceuticals Inc.
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the District of Massachusetts on behalf of investors who acquired Vertex Pharmaceuticals Incorporated securities between May 7, 2012 and June 27, 2012. Full Article
Shareholder Rights Law Firm Johnson & Weaver, LLP Investigates Vertex Pharmaceuticals Inc For Securities Fraud
Shareholder Rights Law Firm Johnson & Weaver, LLP announced it is investigating whether certain officers and Directors of Vertex Pharmaceuticals Inc. breached their fiduciary duties to the Company and violated federal securities laws by making false and misleading statements about the results of clinical trials for drugs related to the treatment of Cystic Fibrosis (CF). Specifically, on May 7, 2012, Vertex issued a press release claiming that the CF patients who received two of drugs during clinical trials showed improvement in their lung functions. On this news, Vertex’s stock price jumped from $37.41 per share to $58.12 per share. Between May 7 and May 25, certain officers and Directors sold over $22 million of their personally owned shares. Full Article
Vertex Pharmaceuticals Inc Announces Positive Results From Viral Kinetic Study Of Nucleotide Analogue Als-2200 In People With Hepatitis C
Vertex Pharmaceuticals Inc and its collaborator Alios BioPharma, Inc. announced positive results from a viral kinetic study of the nucleotide analogue ALS-2200 for the treatment of hepatitis C. There was a median 4.54 log10 reduction in hepatitis C virus (HCV) RNA in people with genotype 1 chronic hepatitis C who were new to treatment (n=8) after seven days of dosing with 200 mg of ALS-2200 once daily. ALS-2200 was well-tolerated in this study, and no patients discontinued due to adverse events. Based on these data, Vertex plans to begin Phase 2 studies this year of 12-week all-oral regimens including ALS-2200 in people with genotype 1 hepatitis C, pending discussions with regulatory agencies. This double-blind, placebo-controlled, Phase 1 trial was designed to evaluate the safety and tolerability of single ascending doses of ALS-2200 in healthy volunteers and of multiple ascending doses in people with genotype 1 chronic hepatitis C. A secondary objective was to evaluate the effects on viral kinetics of ALS-2200 during seven days of dosing in people with hepatitis C. The first part of the trial enrolled healthy volunteers to evaluate pharmacokinetics of single ascending doses of ALS-2200. The second part of the study enrolled people with hepatitis C to evaluate the antiviral activity of multiple ascending doses of ALS-2200. Full Article
Vertex Pharmaceuticals Inc Receives European Approval For KALYDECO
Vertex Pharmaceuticals Inc announced that the European Commission has approved KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages six and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. KALYDECO is the first medicine to target the underlying cause of the disease in these patients. Cystic fibrosis is a rare genetic disease caused by defective or missing CFTR proteins resulting from mutations in the CFTR gene. In people with the G551D mutation, KALYDECO helps the defective CFTR protein function more normally. An estimated 1,100 people in Europe have the G551D mutation. The approval of KALYDECO comes two months after the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion and is the first European approval for Vertex. The European Commission’s decision is based on positive findings from two global Phase 3 studies in which KALYDECO demonstrated and sustained improvements in breathing, weight gain and other measures of disease for people ages six and older with this specific genetic mutation, compared to placebo. In addition, people who took KALYDECO were 55% less likely to have pulmonary exacerbations, or periods of worsening in the signs and symptoms of the disease that often require treatment with antibiotics and hospital visits, than those who received placebo. Full Article
Vertex posts loss, raises cystic fibrosis sales view
- Vertex Pharmaceuticals Inc on Tuesday increased by $20 million the 2013 forecast for sales of its cystic fibrosis drug Kalydeco, and said it anticipates seeking approval in 2014 of a CF combination therapy that has become a focus for investors.
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