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Toggle Summary Vertex and Parion Sciences Establish Collaboration to Develop Epithelial Sodium Channel (ENaC) Inhibitors in Cystic Fibrosis and Other Pulmonary Diseases
-ENaC inhibition aims to restore or improve hydration of cell surfaces in the lungs to improve lung function- -Parion to receive $80 million up-front payment with potential for additional development and regulatory milestones and royalty payments- BOSTON & DURHAM, N.C.
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Toggle Summary Vertex to Present at the Goldman Sachs Healthcare Conference on June 11
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will participate in a fireside chat at the Goldman Sachs Healthcare Conference in Rancho Palos Verdes, CA on Thursday, June 11 th at 12:20 p.m. ET ( 9:20 a.m. PT ).
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Toggle Summary New England Journal of Medicine Publishes Data from Two Phase 3 Studies of ORKAMBITM (lumacaftor/ivacaftor) in People with Cystic Fibrosis who have Two Copies of the F508del Mutation
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the  New England Journal of Medicine (NEJM)  published data from the two Phase 3 studies of ORKAMBI TM (lumacaftor/ivacaftor), an investigational medicine designed to treat the underlying cause of
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Toggle Summary Vertex to Present at the UBS Healthcare Conference on May 19
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Jeffrey Leiden , M.D., Ph.D., Chairman, President & CEO of Vertex will present at the UBS Healthcare Conference in New York, NY on Tuesday, May 19 th at 11:00 a.m. ET .
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Toggle Summary Food and Drug Administration Advisory Panel Voted 12 to 1 to Recommend Approval of ORKAMBI™ (lumacaftor/ivacaftor) to Treat People with Cystic Fibrosis Ages 12 and Older Who Have Two Copies of the F508del Mutation
- FDA decision expected by July 5, 2015 PDUFA date- -Approximately 8,500 people with cystic fibrosis in the U.S. have two copies of the F508del mutation and are ages 12 and older- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
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Toggle Summary Vertex Reports First Quarter 2015 Financial Results
-First quarter 2015 total revenues of $139 million , including net product revenues of $130 million for KALYDECO ® (ivacaftor) in cystic fibrosis- -Cash, cash equivalents and marketable securities of approximately $1.2 billion on March 31, 2015 - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
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Toggle Summary Vertex to Announce First Quarter 2015 Financial Results on April 29
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2015 financial results on Wednesday, April 29, 2015 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 Data from 12-Week Phase 2 Safety Study of VX-661 in Combination with Ivacaftor in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
-The combination was generally well tolerated and all patients completed 12 weeks of treatment- -Mean within-group absolute improvement from baseline in lung function of 4.4 (p=0.009) and 3.0 (p=0.026) percentage points at week 4 and through 12 weeks of treatment, respectively, in patients who
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Toggle Summary Vertex Receives U.S. Food and Drug Administration Approval of KALYDECO® (ivacaftor) for Children with Cystic Fibrosis Ages 2 to 5 who have Specific Mutations in the CFTR Gene
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO ® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance
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Toggle Summary Vertex to Present at Upcoming Investor Conferences
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will present at the RBC Capital Market Healthcare Conference in New York, NY on Tuesday, February 24 th at 11:30 a.m. ET . Vertex will also present at the Cowen and Company Healthcare Conference in
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Toggle Summary Vertex Reports Full-Year and Fourth Quarter 2014 Financial Results and Provides Guidance for 2015
-Full-year 2014 total revenues of $580 million , including net product revenues of $464 million for KALYDECO in cystic fibrosis- -Cash, cash equivalents and marketable securities of approximately $1.4 billion on December 31, 2014 - -Company expects total 2015 KALYDECO net revenues of $560 to $580
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Toggle Summary Vertex Outlines 2015 Business Priorities to Support the Development, Approval and Launch of New Medicines for the Treatment of People with Cystic Fibrosis
-Priority Review granted for combination of lumacaftor and ivacaftor in people with cystic fibrosis ages 12 and older who have two copies of the F508del mutation; PDUFA date of July 5, 2015 - -More than 3,700 people with CF expected to be eligible to receive KALYDECO by end of 2015 supporting
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Toggle Summary Vertex Announces Upcoming Presentation at the J.P. Morgan Healthcare Conference and Date of Fourth Quarter and Full Year 2014 Financial Results
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its corporate presentation at the 33 rd Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 12:30 p.m. ET ( 9:30 a.m. PT ).
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Toggle Summary U.S. Food and Drug Administration Approves KALYDECO® (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
--Approximately 500 people with cystic fibrosis ages 6 and older have the R117H mutation in the United States -- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated  (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug
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Toggle Summary David Altshuler, M.D., Ph.D., Joins Vertex as Executive Vice President of Global Research and Chief Scientific Officer
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated today announced that David Altshuler , M.D., Ph.D., will join the company as Executive Vice President, Global Research and Chief Scientific Officer. Dr. Altshuler was one of the four founding members of the Broad Institute of Harvard
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Toggle Summary Vertex to Present at Deutsche Bank BioFEST on December 2
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will participate in a fireside chat at the Deutsche Bank BioFEST in Boston on December 2 at 8:45 a.m. ET . Management's remarks can be accessed live through Vertex's website at www.vrtx.com
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Toggle Summary Vertex Submits Applications in the U.S. and Europe for Approval of Lumacaftor in Combination with Ivacaftor for People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
-U.S. submission includes request for Priority Review; Accelerated Assessment has been granted in the EU- -Approximately 8,500 people in the U.S. and 12,000 in Europe ages 12 and older have two copies of the F508del mutation- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex to Present at the Credit Suisse Healthcare Conference on November 11
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will present at the Credit Suisse Healthcare Conference on Tuesday, November 11 at 12:00 p.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 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 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 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 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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