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
<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 />
<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 />
<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 />
-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.
- 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
-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,
- 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
– 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
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
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Jan. 04, 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
-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-
-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
-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.
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 and CAMBRIDGE, Mass. and BOSTON, May 11,
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Inco r porated (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an
- 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
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
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.
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
- 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
-- 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
- 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)--
- 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
- 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
- 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
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
- 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
– 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
-Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible for the first time for a medicine that can treat the underlying cause of their disease- LONDON --(BUSINESS WIRE)--Jul. 5, 2023-- Vertex Pharmaceuticals today announced that the European Commission has
- First CRISPR gene-editing filings to be accepted for review by FDA - - FDA grants Priority Review for severe sickle cell disease (SCD) and Standard Review for transfusion-dependent beta thalassemia (TDT) – - PDUFA target action date of December 8, 2023 , for SCD and March 30, 2024 , for TDT –
-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
- 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
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
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
-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-
-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
-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
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
- 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
- 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.
- 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.
-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.
- 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 ™
-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.
- 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
