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Toggle Summary 48-Week Efficacy Comparison of Lexiva/Ritonavir QD vs. Nelfinavir BID in Therapy-Naive HIV+ Patients: Results Published in AIDS
48-Week Efficacy Comparison of Lexiva/Ritonavir QD vs. Nelfinavir BID in Therapy-Naive HIV+ Patients: Results Published in AIDS Research Triangle Park, NC, July 8, 2004 -- The protease inhibitor (PI) LEXIVA(R) (fosamprenavir calcium) dosed with ritonavir (LEXIVA/r) once-daily (QD) as part of a
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Toggle Summary 59 Percent of Patients Overall Achieved SVR with Telaprevir-Based Regimens in Study 107 After Not Achieving SVR with at Least One Prior Course of Treatment for Hepatitis C Virus Infection
<i>-56% of prior treatment null responder patients achieved SVR with a 48-week telaprevir-based regimen-</i> <br /> <i>-97% of prior treatment relapsers and 55% of prior treatment partial responders achieved SVR with 24-week or 48-week telaprevir-based regimens-</i> <br />
HCV
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Toggle Summary 65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study
<i>-17% of people achieved SVR with pegylated-interferon and ribavirin alone in the control arm-</i> <br /> <i>-Safety and tolerability results were consistent with prior Phase 3 studies-</i> <br /> <i>-Completion of rolling New Drug Application submission on track for the fourth quarter 2010-</i> <br />
HCV
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Toggle Summary 75% of Treatment-Naïve Patients with Chronic Hepatitis C Achieve SVR (Viral Cure) with Telaprevir-Based Treatment in Phase 3 Trial
<i><b>-Majority of patients treated with telaprevir received a 24-week regimen-</b></i> <br /> <i><b>-6.9% and 7.7% treatment discontinuation rates due to adverse events in 12- and 8-week telaprevir-based treatment arms -- lower than previous telaprevir trials-</b></i> <br /> <i><b>-First Phase 3 trial results for a direct acting antiviral therapy in hepatitis C-</b></i> <br />
HCV
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Toggle Summary AASLD Presentations Support the Initiation of a Broad Phase II Program with VX-950, an Investigational Oral HCV Protease Inhibitor
Vertex Announces Filing of IND in Support of VX-950 Phase II Development in the U.S.
HCV
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Toggle Summary ADDING MULTIMEDIA FDA Approves ORKAMBI™ (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation
-Approximately 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
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Toggle Summary ADDING MULTIMEDIA FDA Approves TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
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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 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 CHMP Grants Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor) in People Ages 12 and Older With Cystic Fibrosis With the Most Common Genotypes
– If granted Marketing Authorization, people ages 12 and older in Europe who have one F508del mutation and one minimal function mutation will for the first time be able to benefit from a medicine that treats the underlying cause of the disease – – People 12 years of age and older who have two
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Toggle Summary CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Beta Thalassemia
ZUG, Switzerland and CAMBRIDGE and BOSTON, Mass. – April 16, 2019 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the
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Toggle Summary CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Sickle Cell Disease
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Jan. 04, 2019 (GLOBE NEWSWIRE) -- CRISPR Therapeutics&nbsp;(NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the
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Toggle Summary CRISPR Therapeutics and Vertex Announce FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for CTX001 for the Treatment of Sickle Cell Disease
ZUG, Switzerland &nbsp; and &nbsp; BOSTON &nbsp; and &nbsp; CAMBRIDGE, Mass. , &nbsp; Oct. 10, 2018 &nbsp; (GLOBE NEWSWIRE) -- &nbsp; CRISPR Therapeutics&nbsp; (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and &nbsp; Vertex Pharmaceuticals Incorporated &nbsp; (NASDAQ:VRTX)
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Toggle Summary CRISPR Therapeutics and Vertex Announce New Clinical Data for Investigational Gene-Editing Therapy CTX001™ in Severe Hemoglobinopathies at the 25th Annual European Hematology Association (EHA) Congress
-Beta thalassemia: Two patients are transfusion independent at 5 and 15 months after CTX001 infusion; data demonstrate clinical proof-of-concept for CTX001 in transfusion-dependent beta thalassemia- -Sickle cell disease: Patient is free of vaso-occlusive crises at 9 months after CTX001 infusion-
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Toggle Summary CRISPR Therapeutics and Vertex Announce Positive Safety and Efficacy Data From First Two Patients Treated With Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001® for Severe Hemoglobinopathies
-Two patients treated with CTX001 successfully engrafted and demonstrated an initial safety profile consistent with myeloablative busulfan conditioning and autologous hematopoietic stem cell transplant- -Beta thalassemia: Patient is transfusion independent with total hemoglobin level of 11.9 g/dL
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Toggle Summary CRISPR Therapeutics and Vertex Announce Progress in Clinical Development Programs for the Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001
-First patient infused with CTX001 in a Phase 1/2 clinical trial for patients with beta thalassemia- -First patient enrolled in a Phase 1/2 clinical trial of CTX001 for patients with sickle cell disease- ZUG, Switzerland and CAMBRIDGE and BOSTON, Mass., Feb.
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Toggle Summary CRISPR Therapeutics and Vertex Pharmaceuticals Announce FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX001™ for the Treatment of Severe Hemoglobinopathies
CTX001 has received Orphan Drug Designation from the U.S. Food and Drug Administration for transfusion-dependent beta thalassemia and from the European Medicines Agency for sickle cell disease and transfusion-dependent beta thalassemia ZUG, Switzerland&nbsp;and&nbsp;CAMBRIDGE, Mass.&nbsp;and&nbsp;BOSTON,&nbsp;May 11,
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Toggle Summary CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Inco r porated &nbsp;(Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an
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Toggle Summary CRISPR Therapeutics and Vertex Present New Data for Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at American Society of Hematology Annual Meeting and Exposition, Together With Publication in the New England Journal of Medicine
- Beta thalassemia: All seven patients were transfusion independent with 3 to 18 months of follow-up after CTX001 infusion - - Sickle cell disease: All three patients were free of vaso-occlusive crises with 3 to 15 months of follow-up after CTX001 infusion - - Nineteen patients have been dosed with
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Toggle Summary CRISPR Therapeutics and Vertex Provide Update on FDA Review of Investigational New Drug Application for CTX001 for the Treatment of Sickle Cell Disease
BOSTON and ZUG, Switzerland and CAMBRIDGE, Mass. , May 30, 2018 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug
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Toggle Summary CRISPR Therapeutics and Vertex to Host Investor Webcast to Review Data Presented at the 62nd American Society of Hematology Annual (ASH) Meeting and Exposition for Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001™ in Sickle Cell Disease and Beta Thalassemia
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON , Dec. 01, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the companies will host an investor webcast on December 9, 2020 at 8:00 a.m.
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Toggle Summary CRISPR/Cas9 Gene-Editing Therapy CTX001™ for Severe Hemoglobinopathies Accepted for Plenary Presentation at the 62nd American Society of Hematology (ASH) Meeting and Exposition
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Nov. 04, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data in seven patients from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9
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Toggle Summary Cystic Fibrosis Foundation Therapeutics Awards $21 Million to Vertex Pharmaceuticals Under Expanded Agreement
- New Collaboration Builds on Drug Discovery Progress at Vertex -
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Toggle Summary Data From Follow-Up Study of KALYDECO™ (ivacaftor) Showed Durable Improvements in Lung Function and Other Measures of Disease in People with Cystic Fibrosis Who Have a Specific Genetic Mutation (G551D)
- Data from nine presentations at the European Cystic Fibrosis Society Conference underscore Vertex's ongoing commitment to change CF treatment by targeting the underlying cause of the disease - DUBLIN --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today new data
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Toggle Summary Data from Phase 2 Combination Study of VX-809 and Ivacaftor in People with Cystic Fibrosis Who Have the Most Common Genetic Mutation (F508del) Presented at North American Cystic Fibrosis Conference
-- Additional KALYDECO™ (ivacaftor) and CF pipeline presentations highlight Vertex's commitment to advancing CF treatment by targeting the underlying cause of the disease -- ORLANDO, Fla. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from a Phase 2
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Toggle Summary Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12)
- INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens, and no patients experienced HIV breakthrough - - Enrollment is ongoing in Phase 3 study evaluating 24- and 48-week treatment durations in people who are co-infected - SEATTLE --(BUSINESS WIRE)--
HCV
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Toggle Summary Data From Phase 3 Studies Showed Substantial Improvements in SVR (Viral Cure) Rates With Telaprevir-Based Therapy Compared to Currently Available Medicines in People With Hepatitis C, Regardless of Their IL28B Genotype Status
- 90% of people with the ‘CC' variation of IL28B who were new to treatment and received a telaprevir-based regimen achieved a viral cure, 78% of them were eligible to stop all treatment at 24 weeks - - Nearly three-fold improvement in viral cure rates was observed among people with the ‘CT' and
HCV
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Toggle Summary Data from the First Part of a Phase 2 Study Support the Approach of Treating the Most Common Form of Cystic Fibrosis (F508del) by Targeting the Underlying Cause of the Disease With a Combination of KALYDECO™ (ivacaftor) and VX-809
- New data at North American CF Conference showed a reduction in sweat chloride when KALYDECO was added to VX-809 in people with the F508del mutation — - Part 2 of study now enrolling patients - ANAHEIM, Calif. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced
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Toggle Summary Data from Viral Kinetic Study Showed Rapid Reduction of HCV RNA with ALS-2200 (VX-135), Vertex's Oral Nucleotide Analogue in Development for the Treatment of Hepatitis C
- 4.54 log 10 median reduction in HCV RNA after 7 days of dosing; ALS-2200 was well-tolerated with no serious adverse events and no discontinuations due to adverse events - - Vertex moving forward with multiple Phase 2 trials in early 2013 exploring all-oral combinations, including VX-135 with
HCV
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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 European Commission Approves KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Children With Cystic Fibrosis Ages 6 to 11 Years
- More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic fibrosis for the first time - LONDON --(BUSINESS WIRE)--Jan. 11, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval for
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Toggle Summary European Commission Approves KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Cystic Fibrosis in People Ages 12 Years and Older
– For the first time, up to 10,000 people in Europe ages 12 years and older with one F508del mutation and one minimal function mutation will be eligible for a medicine that treats the underlying cause of cystic fibrosis – – People 12 years of age and older who have two F508del mutations will also
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Toggle Summary FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
-FDA Grants Priority Review of the application and sets a PDUFA target action date of March 19, 2020 - -Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in
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Toggle Summary FDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Additional CFTR Mutations
- More than 600 people with certain rare CF mutations could become newly eligible for TRIKAFTA, SYMDEKO or KALYDECO - BOSTON --(BUSINESS WIRE)--Sep. 1, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental
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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 FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis
HCV
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Toggle Summary FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment- -Vertex launches a comprehensive financial assistance and patient support program- -Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-
HCV
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age
-Approval provides opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from a cohort of the Phase 3 ARRIVAL study support treatment with KALYDECO in children ages four to
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
-Opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from Phase 3 ARRIVAL study support treatment with KALYDECO in children ages six to
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) as First and Only Medicine to Treat the Underlying Cause of CF in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene
-Data from Phase 3 ARRIVAL study support treatment with KALYDECO in children ages 12 to
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO ® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) for More Than 900 People Ages 2 and Older with Cystic Fibrosis Who Have Certain Residual Function Mutations
- Precision medicine decision based on in vitro data and supported by more than five years of real-world clinical data that demonstrate KALYDECO's strong safety and efficacy profile for eligible patients - - Vertex working with FDA to obtain rapid approval for more than 600 additional people who
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Toggle Summary FDA Approves KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis
- FDA approval received 3 months after submission of New Drug Application - - KALYDECO approved to treat people with CF who have a specific genetic mutation - - Vertex launches a comprehensive financial assistance and patient support program - CAMBRIDGE, Mass.
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Toggle Summary FDA Approves ORKAMBI® (lumacaftor/ivacaftor) as First Medicine to Treat the Underlying Cause of Cystic Fibrosis for Children Ages 2-5 Years with Most Common Form of the Disease
- Approximately 1,300 people in the U.S. ages 2 through 5 years have two copies of the F508del mutation, the most common genetic form of the disease - BOSTON --(BUSINESS WIRE)--Aug. 7, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S.
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Toggle Summary FDA Approves ORKAMBI™ (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation
-Approximately 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
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Toggle Summary FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene
- SYMDEKO is Vertex's third medicine to treat the underlying cause of CF - - SYMDEKO to begin shipping to pharmacies this week - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO ™
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Toggle Summary FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene
-SYMDEKO is now approved for patients 6 years of age and older with two copies of the F508del mutation or one copy of a responsive mutation- -Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range- BOSTON --(BUSINESS WIRE)--Jun.
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Toggle Summary FDA Approves TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
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Toggle Summary FDA Approves Updated Labeling for LEXIVA
- Coadministration With Esomeprazole Does Not Affect Blood Levels of LEXIVA -
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Toggle Summary FDA Approves Updated Labeling for LEXIVA
- Coadministration With Esomeprazole Does Not Affect Blood Levels of LEXIVA -
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