LONDON --(BUSINESS WIRE)--Sep. 14, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of KAFTRIO ®* (ivacaftor/tezacaftor/elexacaftor)
-Application to add ~200 non-F508del CFTR mutations to the KAFTRIO ® license- -If approved, ~2,800 people with cystic fibrosis in the European Union ages 2 and above could receive a medicine that treats the underlying cause of their disease for the first time- LONDON --(BUSINESS WIRE)--Nov.
-CF patients in England will be among the first in Europe to benefit from access to KAFTRIO ® , if the medicine is approved by the European Commission - LONDON --(BUSINESS WIRE)--Jun. 30, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has expanded its
- More than 600 people with certain rare CF mutations are now eligible for TRIKAFTA, SYMDEKO or KALYDECO - BOSTON --(BUSINESS WIRE)--Dec. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for TRIKAFTA ®
- Vertex will initiate a Phase 1/2 clinical trial in first half of 2021 - - VX-880 is the first stem cell-derived therapy evaluating fully differentiated pancreatic islet cells for the treatment of T1D - BOSTON --(BUSINESS WIRE)--Jan. 28, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
– Vertex to initiate a Phase 1/2 clinical trial in the coming months – – VX-264 is the second investigational program in Vertex’s pipeline containing stem cell-derived, fully differentiated pancreatic islet cells for the treatment of type 1 diabetes – – VX-264 program does not require
– ADPKD is the most common inherited kidney disease, with no treatments currently available that address the underlying cause of disease – – Vertex to initiate a Phase 1 clinical trial in healthy volunteers this month – – ADPKD is Vertex’s 10th disease area in the clinic, further expanding the
– VX-880 is the first investigational stem cell-derived therapy utilizing fully differentiated, insulin-producing pancreatic islet cells for the treatment of type 1 diabetes – – VX-880 is the first and only pancreatic islet replacement therapy known to receive Fast Track Designation – BOSTON
BOSTON --(BUSINESS WIRE)--Jul. 5, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated
-New 344,000 square foot cell and genetic therapies research and manufacturing facility to be built- -Facility to support continued R&D growth- BOSTON --(BUSINESS WIRE)--May 17, 2022-- At a dedication today of the new Jeffrey Leiden Center for Cell and Genetic Therapies in Boston’s Seaport, Vertex
LONDON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced it has reached a pricing and reimbursement agreement for ORKAMBI ® (lumacaftor/ivacaftor) with the German Federal Association of the Statutory Health Insurances (GKV-SV).
- Vertex granted nine Breakthrough Therapy Designations and three PRIME designations across its pipeline programs to date – BOSTON --(BUSINESS WIRE)--Jun. 8, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has granted inaxaplin
-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
Agreement also enables the possibility of rapid patient access to future triple combination regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) once approved in Switzerland LONDON --(BUSINESS WIRE)--Apr. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has
- Novel, inhaled mRNA therapy intended for the ~5,000 people with CF who cannot benefit from CFTR modulators - - VX-522 clinical trial in people with CF to initiate in coming weeks - BOSTON --(BUSINESS WIRE)--Dec. 12, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that
- If accepted by the Scottish Medicines Consortium (SMC) for use on the NHS in Scotland , eligible patients could have access to these precision cystic fibrosis medicines in 2019 - - While the SMC reviews the submissions, clinicians can apply for access to these CF medicines via the PACS Tier 2
-More than 25,000 people have started treatment for hepatitis C with INCIVEK ® , positioning Vertex for continued growth, earnings and cashflow in 2012- -Preparations for approval and launch of KALYDECO TM ongoing; additional studies of KALYDECO planned for mid-2012- -Nine new medicines in
-Hepatitis C: Submission of New Drug Application complete for telaprevir- -Cystic Fibrosis: First Phase 3 data for VX-770 expected in first quarter 2011- -Additional ongoing trials in HCV, CF, epilepsy and rheumatoid arthritis- -Vertex enters 2011 with cash and cash equivalents position of more
- The agreement allows for reimbursement of ORKAMBI for people with cystic fibrosis who have two copies of the F508del mutation from July 1 - - A framework for assessment and access to our future cystic fibrosis medicines is included as part of the agreement - LONDON --(BUSINESS WIRE)--Jun.
-Agreement provides access to ORKAMBI for people who have two copies of the F508del mutation and expands access to KALYDECO for all eligible patients- LONDON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced it has reached an agreement with the Health Service
- With this reimbursement agreement more than 1,500 patients now have access to a CFTR modulator therapy for the first time - LONDON --(BUSINESS WIRE)--Jun. 28, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a national reimbursement agreement with the French Health
- Proof-of-concept studies of VX-548 in acute pain to initiate in the second half of the year - BOSTON --(BUSINESS WIRE)--Apr. 26, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will advance the selective NaV1.8 inhibitor, VX-548, into Phase 2 clinical
The Vertex Research Innovation Award (RIA) Program Will Now Provide up to $10M in Grants Over the Next Five Years to New Postdoctoral and Faculty Researchers from Around the World BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today a new $750,000 program
Eligible patients in Scotland will immediately have access to ORKAMBI (lumacaftor/ivacaftor) and SYMKEVI (tezacaftor/ivacaftor) in combination with ivacaftor LONDON --(BUSINESS WIRE)--Sep. 12, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that eligible cystic fibrosis
- ALS-2158: Well-tolerated in a seven-day viral kinetic study; development discontinued due to lack of efficacy - - ALS-2200: Data from additional cohort of seven-day viral kinetic study with ALS-2200 (200 mg, QD) in combination with ribavirin show median 4.18 log 10 reduction in HCV RNA with 5 of
- 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
BOSTON , Dec. 28, 2020 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its New Drug Submission for TRIKAFTA®, Vertex 's investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in
- Reimbursement agreement also includes certain future indication extensions across all Vertex CF medicines - - Approximately 1,400 patients will now have access to a CFTR modulator for the first time - LONDON --(BUSINESS WIRE)--Jun. 25, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
- Presentation of data from a Phase 3 study of ORKAMBI in children ages 6-11 with two copies of the F508del mutation demonstrated improvements in lung function and sweat chloride; study also published online in The Lancet Respiratory Medicine today - - ECFS data presentations demonstrate that
BOSTON --(BUSINESS WIRE)--Nov. 4, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the company has partnered with basketball Hall-of-Famer Alonzo Mourning to launch “Power Forward” ( www.PowerForwardTogether.com ), an educational initiative aimed at raising awareness
-VX-440 to be evaluated as part of 4-week triple combination dosing with tezacaftor (VX-661) and ivacaftor; VX-152 to be evaluated as part of 2-week triple combination dosing- -Studies to enroll people with cystic fibrosis who have one copy of the F508del mutation and a minimal function mutation
-New treatment arm to evaluate all oral, triple combination regimen of telaprevir, VX-222, and ribavirin- CAMBRIDGE, Mass., Nov 10, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2
<ul><li>VX-770 was well-tolerated when dosed as 150 mg and 250 mg twice daily for 28 days</li><li>VX-770 resulted in a significant increase in FEV1, and significant changes in sweat chloride and nasal potential difference, important markers of CFTR function</li>
<li>Researchers to present 28-day results at the North American Cystic Fibrosis Conference on October 23</li></ul>
- First patient dosed with VX-880 demonstrated restoration of insulin production and achieved C-peptide of 560 pmol/L in response to Mixed Meal Tolerance Test (MMTT) at Day 90 Visit - - 91% decrease in daily insulin requirement and simultaneous robust improvements in glucose control as measured by
-Interim results to be presented in late-breaker poster<br> presentation at EASL on April 24-<br><br> -Significant early on-treatment viral response from patients who<br> previously failed therapy-
-Phase 2 data showed mean absolute improvements in ppFEV 1 of 9.7 and 12.0 percentage points for VX-152 and VX-440, respectively, in triple combination with tezacaftor and ivacaftor in F508del/Min patients; Initial data from Phase 1 study showed mean absolute improvement in ppFEV 1 of 9.6
-Treatment with the NaV1.8 inhibitor VX-150 showed significant relief of pain in patients with small fiber neuropathy and was generally well tolerated- -Third positive Phase 2 proof-of-concept study for VX-150 further validates the potential role of NaV1.8 inhibition for the treatment of multiple
BOSTON --(BUSINESS WIRE)--Sep. 10, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the company has completed a global Phase 3 study of TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children ages 6 through 11 years old with cystic fibrosis (CF) who have
--Interim analysis of 14-day study of VX-770 shows a significant<br> improvement in lung function --<br><br> --Lung function data supported by corresponding improvements in<br> disease-related biomarkers--<br><br> --Results to be shared with health authorities in order to<br> identify the most rapid path forward --
-Study met primary safety endpoint and showed improvements across multiple endpoints, including measures of pancreatic function- -Potential to modify the course of CF in children as young as one year of age- -Results support FDA and EMA filings in the first quarter of 2018- BOSTON --(BUSINESS
– Treatment with VX-147 led to a statistically significant, substantial and clinically meaningful mean reduction in proteinuria of 47.6% at 13 weeks compared to baseline and was well tolerated – – Results provide clinical proof of concept for the first genetically targeted approach to treating
– Treatment with the NaV1.8 inhibitor VX-548 led to statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the Numeric Pain Rating Scale (NPRS) – – VX-548 was generally well tolerated – – Vertex plans to advance VX-548 into pivotal
– Treatment with the once-daily vanza triple CFTR modulator regimen met all primary and key secondary endpoints in two randomized controlled trials in people with CF ages 12 years and older – – Results were more pronounced in the single-arm study in children ages 6 to 11 years, demonstrating the
– Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials – – Treatment with VX-548 was also shown to be effective in
- 4.54 log 10 median reduction in HCV RNA observed in people with genotype 1 hepatitis C treated with a once-daily 200 mg dose of ALS-2200 for seven days; treatment was well-tolerated- - Phase 2 studies of 12-week all-oral regimens planned for this year - CAMBRIDGE, Mass.
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 10 abstracts from its cystic fibrosis (CF) research and development program will be presented at the 26th Annual North American Cystic Fibrosis Conference (NACFC) in Orlando, Fla.
-Final data to be presented from Phase 2 study in rheumatoid arthritis- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that two abstracts related to its investigational oral JAK3 inhibitor, VX-509, will be presented at the 2011 Annual Meeting
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 11 abstracts from its hepatitis C research and development program will be presented at The Liver Meeting ® , the 63rd Annual Meeting of the American Association for the Study of Liver
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that nine abstracts from its cystic fibrosis (CF) research program, which is aimed at discovering and developing medicines that target the underlying cause of CF, will be presented at the 25th
-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