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Date Title and Summary Additional Formats
Toggle Summary Vertex Reports Third Quarter 2014 Financial Results
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter ended September 30, 2014 . Vertex reported total third quarter 2014 GAAP revenues of $179 million , including revenues of $127 million from KALYDECO ®
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Toggle Summary FDA Advisory Committee Recommends Approval of KALYDECO® (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration's Pulmonary Allergy Drugs Advisory Committee (PADAC) voted 13-2 to recommend approval of KALYDECO ® (ivacaftor) in people with cystic fibrosis (CF) ages 6 and
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Toggle Summary Vertex to Announce Third Quarter 2014 Financial Results on October 28
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2014 financial results on Tuesday, October 28, 2014 after the financial markets close. The company will host a conference call and webcast at 5:00 p.m. ET .
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Toggle Summary Vertex Reviews Recent Progress and Announces Upcoming Milestones in the Development of Multiple Combinations of Medicines that Target the Underlying Cause of Cystic Fibrosis
-Data from across Vertex's cystic fibrosis research and development programs to be presented at the 28 th Annual North American Cystic Fibrosis Conference (NACFC) beginning today- -Interim analysis of rollover study following the Phase 3 TRAFFIC and TRANSPORT studies showed sustained improvements
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Toggle Summary Vertex Announces Upcoming Presentations of Data at North American Cystic Fibrosis Conference - October 9 to 11, 2014
-Data from Phase 3 TRAFFIC and TRANSPORT studies of lumacaftor in combination with ivacaftor and from Phase 3 rollover study of patients who completed TRAFFIC and TRANSPORT to be presented- -Other presentations include studies of ivacaftor in people with cystic fibrosis who have the R117H mutation,
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Toggle Summary Vertex to Present at the Morgan Stanley Global Healthcare Conference on September 10
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will present at the Morgan Stanley Global Healthcare Conference on Wednesday, September 10 at 8:35 a.m. ET . Management's remarks can be accessed live through Vertex's website at www.vrtx.com in
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Toggle Summary Vertex Receives European Approval for KALYDECO™ (ivacaftor) in Eight Non-G551D Gating Mutations
-In Europe, approximately 250 people ages 6 and older have one of 8 additional gating mutations- -KALYDECO is the first medicine to treat the underlying cause of CF in people with specific non-G551D gating mutations- EYSINS, Switzerland --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated
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Toggle Summary Vertex Reports Second Quarter 2014 Financial Results and Provides Updates on Key Research and Development Programs
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter ended June 30, 2014. Vertex reported total second quarter 2014 revenues of $138 million , including revenues of $113 million from KALYDECO ® (ivacaftor).
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Toggle Summary Vertex to Announce Second Quarter 2014 Financial Results on July 29
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second quarter 2014 financial results on Tuesday, July 29, 2014 after the financial markets close. The company will host a conference call and webcast at 5:00 p.m. ET .
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Toggle Summary Vertex Announces Retirement of Peter Mueller, Ph.D.
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Peter Mueller , Ph.D., Executive Vice President of Global Research and Development and Chief Scientific Officer, will retire after more than 10 years with the company. Dr.
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Toggle Summary Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for Use of KALYDECO® (ivacaftor) in People 18 and Older with Cystic Fibrosis who have the R117H Mutation
-Marketing Authorization Application (MAA) variation in Europe planned for third quarter of 2014- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S.
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO™ (ivacaftor) in Eight Non-G551D Gating Mutations
-In Europe, approximately 250 people ages 6 and older have one of 8 additional gating mutations- -KALYDECO is the first medicine to treat the underlying cause of CF in people with non-G551D gating mutations- EYSINS, Switzerland --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary Two 24-Week Phase 3 Studies of Lumacaftor in Combination with Ivacaftor Met Primary Endpoint with Statistically Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis who have Two Copies of the F508del Mutation
-Combination of lumacaftor and ivacaftor is the first regimen designed to treat the underlying cause of CF in people with two copies of the F508del mutation, the most common form of the disease- -All four 24-week treatment arms achieved primary endpoint of mean absolute improvement in FEV 1
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Toggle Summary Vertex Licenses VX-787 to Janssen Pharmaceuticals for the Treatment of Influenza
-VX-787 is an investigational medicine discovered by Vertex that is designed to directly inhibit replication of the influenza virus- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has entered into a licensing agreement with Janssen
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Toggle Summary Vertex Announces a Signed Letter of Intent to Enable Public Reimbursement of KALYDECO® (ivacaftor) in Canada for Eligible People with Cystic Fibrosis
-Before patients can get access through public reimbursement, each participating province or territory must decide to reimburse KALYDECO through its individual drug program- -Approximately 100 people ages 6 and older in Canada have the G551D mutation - BOSTON --(BUSINESS WIRE)-- Vertex
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Toggle Summary Vertex Announces Presentation of New KALYDECO™ (ivacaftor) Data at European Cystic Fibrosis Society Conference
-New data showed that KALYDECO reduced the loss of lung function by half over 3 years in people with CF who have the G551D mutation compared to similar untreated patients- -New data from rollover study of ivacaftor in people with the R117H mutation support earlier results from Phase 3 study that
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Toggle Summary Proof-of-Concept Study of Ivacaftor Monotherapy Showed Improvements in Lung Function After Two Weeks of Treatment in People with Cystic Fibrosis who have a Residual Function Mutation
-Data are consistent with in vitro observations in residual function mutations showing that ivacaftor improved CFTR activity- -8-week open-label period showed improvements in lung function- -Data support plans to initiate a Phase 3 study of ivacaftor in people with CF who have a residual function
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Toggle Summary Vertex to Present at the Goldman Sachs Global Healthcare Conference on June 10
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will present at the Goldman Sachs Global Healthcare Conference on Tuesday, June 10 at 11:00 a.m. ET . Management's remarks can be accessed live through Vertex's website at www.vrtx.com in the
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Toggle Summary Vertex to Present at the UBS Global Healthcare Conference on May 20
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will present at the UBS Global Healthcare Conference on Tuesday, May 20 at 11:00 a.m. ET . The audio portion of the remarks will be accessible live through Vertex's website at www.vrtx.com in the
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Toggle Summary William Young Joins Vertex Board of Directors
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that William Young joined its board of directors as an independent director. Mr. Young was elected to the class of directors whose term expires in 2017. The Vertex board now consists of 10 members. "Mr.
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Toggle Summary Addition of VX-661 to KALYDECO® (ivacaftor) Improves Lung Function in People with CF Who Are Heterozygous for the F508del and G551D Mutations in 28-day Phase 2 Proof-of-Concept Study
-Data provide proof-of-concept for use of VX-661 to further enhance CFTR function in people taking KALYDECO who have the F508del mutation and another mutation known to respond to KALYDECO alone- -Statistically significant improvements in lung function, as well as decreases in sweat chloride,
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Toggle Summary Vertex Reports First Quarter 2014 Financial Results and Provides Updates on Key Business Priorities
-Net product revenues of $100 million for KALYDECO in cystic fibrosis- -Cash, cash equivalents and marketable securities of $1.32 billion on March 31, 2014 - -Six-month dosing period complete for Phase 3 TRAFFIC and TRANSPORT studies of lumacaftor in combination with ivacaftor for people with CF
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Toggle Summary U.S. Food and Drug Administration Approves KALYDECO™ (ivacaftor) for Use in Eight Additional Mutations that Cause Cystic Fibrosis
-KALYDECO is the first medicine to treat the underlying cause of CF for people with specific mutations in the CFTR gene- -KALYDECO facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein- -The eight additional mutations are present in
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Toggle Summary Vertex Reports Full-Year and Fourth Quarter 2013 Financial Results and Provides Financial Guidance for 2014
-Full-year 2013 total revenues of $1.21 billion , including net product revenues of $371.3 million for KALYDECO in cystic fibrosis and $466.3 million for INCIVEK in hepatitis C- -Cash, cash equivalents and marketable securities of approximately $1.47 billion on December 31, 2013- -Company expects
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Toggle Summary Vertex Reviews Corporate Strategy and Outlines Key 2014 Business Priorities at the 32nd Annual J.P. Morgan Healthcare Conference
-KALYDECO: 2014 revenue growth anticipated from geographic expansion and approval for use in patients with additional CFTR mutations- -Lumacaftor in combination with ivacaftor: results from two Phase 3 studies, TRAFFIC and TRANSPORT, expected mid-year in people with two copies of the F508del
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Toggle Summary Vertex Announces Sustained Viral Response Rate (SVR4) Data from All-Oral Study of VX-135 in Combination with Daclatasvir in Hepatitis C
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135, Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor, in combination with daclatasvir, Bristol-Myers
HCV
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Toggle Summary Vertex Announces Appointment of Jeffrey A. Chodakewitz, M.D., as Chief Medical Officer and Senior Vice President of Global Medicines Development
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced the appointment of Jeffrey A. Chodakewitz , M.D., as Chief Medical Officer and Senior Vice President. Dr. Chodakewitz has more than 20 years of experience leading global development organizations in the
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Toggle Summary Vertex Announces Results of Phase 3 Study of Ivacaftor in People with CF who have the R117H Mutation
-Mean absolute treatment difference in lung function across all patients was 2.1 percentage points (p=0.20) and mean relative treatment difference was 5.0% (p=0.06)(n=69); study did not meet its primary endpoint- -Pre-specified analysis of patients 18 years of age and older (n=50) showed
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Toggle Summary Vertex Sells INCIVO ® Product Royalty Rights for $152 Million
-Vertex to receive $152 million cash payment from Janssen in 2013; will no longer receive royalties on INCIVO sales beginning in 2014- -Company increases 2013 year-end guidance for cash, cash equivalents and marketable securities to in excess of $1.4 billion - CAMBRIDGE, Mass.
HCV
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Toggle Summary Vertex Focuses Investment on Future Opportunities in Cystic Fibrosis and Other Key Research and Development Programs and Reduces Workforce Related to INCIVEK
-Changes result from the continued and rapid decline in the number of people being treated with INCIVEK as new hepatitis C medicines near approval- -370 positions, including 175 in Massachusetts , to be eliminated, primarily related to support of INCIVEK- CAMBRIDGE, Mass.
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Toggle Summary Vertex Reports Third Quarter 2013 Financial Results and Provides Financial Outlook for 2014
-Third quarter 2013 total revenues of $222 million , including net product revenues of $101 million for KALYDECO in cystic fibrosis and $86 million for INCIVEK in hepatitis C- -Cash, cash equivalents and marketable securities of approximately $1.42 billion on September 30, 2013- -Company reduces
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Toggle Summary Oral Selective JAK3 Inhibitor VX-509 Showed Statistically Significant Improvements in Signs and Symptoms of Rheumatoid Arthritis After 12 Weeks of Treatment in Phase 2b Study
-All doses of VX-509 showed statistically significant ACR20 and ACR50 responses compared to placebo and statistically significant improvement from baseline in DAS28 compared to placebo- -Three highest doses of VX-509: ACR20 of 58% to 68% versus 18% for placebo; statistically significant ACR70
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Toggle Summary Vertex Announces Recent Progress and Upcoming Milestones in Research and Development Programs for Cystic Fibrosis
-Enrollment complete for TRAFFIC and TRANSPORT Phase 3 studies of lumacaftor (VX-809) in combination with ivacaftor for people with two copies of the F508del mutation (homozygous); data expected in mid-2014- -12-week Phase 2 study of VX-661 in combination with ivacaftor planned for people with two
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Toggle Summary Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for KALYDECO™ (ivacaftor) Monotherapy for People with Non-G551D Gating Mutations
-sNDA also includes long-term safety and efficacy data for KALYDECO from PERSIST open-label rollover study- -Marketing Authorization Application (MAA) variation in Europe planned for October 2013 - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today
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Toggle Summary Vertex to Announce Third Quarter 2013 Financial Results on October 29
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2013 financial results on Tuesday, October 29, 2013 after the financial markets close. The company will host a conference call and webcast at 5:00 p.m. ET .
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Toggle Summary Results from Phase 3 Study of Ivacaftor Monotherapy Showed Statistically Significant Improvements in Lung Function in People with non-G551D Gating Mutations
-Mean absolute treatment difference in lung function (percent predicted FEV 1 ) between treatment with ivacaftor and placebo was 10.7% (p < 0.0001); mean relative treatment difference between treatment with ivacaftor and placebo was 14.2% (p < 0.0001)- -Statistically significant improvements
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Toggle Summary Vertex Reports Second Quarter 2013 Financial Results and Reviews Recent Progress and Upcoming Milestones in Clinical Development Programs
-Second quarter 2013 total revenues of $311 million , including net product revenues of $99 million for KALYDECO in cystic fibrosis and $156 million for INCIVEK in hepatitis C; cash position of approximately $1.43 billion on June 30, 2013 - -Data from Phase 3 study of ivacaftor monotherapy support
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Toggle Summary Vertex Provides Update on Ongoing All-Oral Studies of VX-135 in Hepatitis C
-U.S. Study: FDA places partial clinical hold on ongoing Phase 2 U.S. study of VX-135, preventing evaluation of 200 mg dose following observation of elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in Phase 2 study in Europe ; evaluation of 100 mg dose
HCV
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Toggle Summary Vertex Receives Australian Approval for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People with a Specific Genetic Mutation (G551D)
-- Approximately 250 people in Australia have the G551D mutation in the CFTR gene -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Therapeutic Goods Administration (TGA) of Australia has approved KALYDECO™ (ivacaftor) for people
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Toggle Summary Vertex Completes Redemption of Convertible Senior Subordinated Notes
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has completed its previously announced call for redemption of $400 million in aggregate principal amount of 3.35% Convertible Senior Subordinated Notes due 2015.
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Toggle Summary Vertex Calls for Redemption of $400 Million in Convertible Senior Subordinated Notes Due 2015
-2015 Notes convertible at a conversion price of approximately $48.83 per share- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that it has called for redemption of its outstanding $400.0 million in aggregate principal amount of 3.35% Convertible
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Toggle Summary Vertex Reports First Quarter 2013 Financial Results and Reviews Recent Progress in Development Programs for Cystic Fibrosis and Hepatitis C
-First quarter 2013 total revenues of $328 million , including net product revenues of $206 million for INCIVEK in hepatitis C and $62 million for KALYDECO in cystic fibrosis- -Cystic fibrosis: Enrollment ongoing in Phase 3 program for VX-809 in combination with ivacaftor for people with two copies
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Toggle Summary Vertex Announces New Data that Showed High Viral Cure Rates with a Total of 12 and 24 Weeks of Telaprevir Combination Treatment Among People with Genotype 1 Hepatitis C Who Have the IL28B CC Genotype
- Interim analysis of the Phase 3b CONCISE study showed SVR12 rates of 87 percent with 12 total weeks of treatment and 97 percent with 24 total weeks of treatment among people who achieved RVR and completed 12 weeks of treatment - AMSTERDAM --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated
HCV
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Toggle Summary ALS-2200 (VX-135) Viral Kinetic Study Shows Significant Reduction in HCV RNA in People with Genotype 1 Hepatitis C Virus Infection and Cirrhosis, and in People with Genotypes 2, 3 or 4 HCV Infection
- After seven days of once-daily dosing with 200 mg of ALS-2200, genotype 1 patients with cirrhosis had a median 4.08 log 10 reduction in HCV RNA; among people with genotypes 3 or 4, there was a median 4.65 log 10 reduction in HCV RNA - - Data are consistent with previously reported ALS-2200
HCV
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Toggle Summary Treatment with VX-661 and Ivacaftor in a Phase 2 Study Resulted in Statistically Significant Improvements in Lung Function in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
-Treatment with combination of VX-661 and ivacaftor for 28 days in two highest dose groups resulted in mean relative increases in lung function (percent predicted FEV 1 ) of 9.0% (p=0.01) and 7.5% (p=0.02) versus placebo - -VX-661 was generally well-tolerated alone and in combination with
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Toggle Summary Vertex Enters Agreement with Bristol-Myers Squibb for Phase 2 All-Oral Studies of VX-135 in Combination with Daclatasvir for the Treatment of Hepatitis C
-Two Phase 2 studies to evaluate once-daily combination of Vertex's investigational nucleotide analogue VX-135 and BMS' investigational NS5A replication complex inhibitor daclatasvir- -Study in people with genotype 1 hepatitis C planned to begin in second quarter of 2013- -Study in people with
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Toggle Summary VX-787 Showed Significant Antiviral Activity and Reduced the Severity and Duration of Influenza Symptoms in Phase 2 Challenge Study
- Treatment with highest dosing regimen of VX-787 reduced viral shedding by 94 percent versus placebo; Duration of flu symptoms were reduced by nearly half - - VX-787 is an investigational new class of medicine designed to directly inhibit replication of the influenza virus - CAMBRIDGE, Mass.
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Toggle Summary Vertex Announces Initiation of Pivotal Phase 3 Program of VX-809 in Combination with Ivacaftor for the Treatment of People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
-Global studies to evaluate two different doses of VX-809 in combination with ivacaftor- - 24-week safety and efficacy data and submission of New Drug Application expected in 2014- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation
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Toggle Summary Republic of Ireland Approves Funding for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis, for People with a Specific Genetic Mutation (G551D)
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the Health Service Executive (HSE) in the Republic of Ireland will fund KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), for people ages 6 and
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Toggle Summary Vertex Reports Full-Year and Fourth Quarter 2012 Financial Results and Provides Updates on Key Development Programs
-2013 investment focused on key development programs in cystic fibrosis, hepatitis C and autoimmune diseases- -Full-year 2012 revenues of $1.53 billion , including net product revenues of $1.16 billion for INCIVEK in hepatitis C and $171.6 million for KALYDECO in cystic fibrosis- -Company ends 2012
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