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
-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
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).
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 .
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.
-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.
-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)
-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
-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
-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
-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
-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
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
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
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.
-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,
-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
-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
-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
-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
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
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
-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
-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.
-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
-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.
-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
-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
-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
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 .
-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
-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
-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
-- 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
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.
-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
-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
- 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
- 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
-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
-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
- 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.
-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
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
-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
-2013 investment focused on key development programs in cystic fibrosis, hepatitis C and autoimmune diseases- -First two Breakthrough Therapy Designations from U.S. FDA granted to ivacaftor monotherapy and to the combination regimen of VX-809 and ivacaftor for the treatment of cystic fibrosis- SAN
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that a decision has been made by the National Health Service (NHS) in England to fund KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), for people
- Revised label includes Boxed Warning detailing risk of serious skin reactions observed in the post-marketing setting that require treatment discontinuation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK ® (telaprevir)
-- Approximately 100 people in Canada have the G551D mutation in the CFTR gene -- -- First medicine resulting from 1989 co-discovery of CF gene by researchers in Canada and the U.S. -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that