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Press Releases

Date Title Additional Format
Aug 20, 2019
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
Jul 31, 2019
Vertex Reports Second-Quarter 2019 Financial Results
- Product revenues of $940 million , a 25% increase compared to 2018 - - Company increases full-year 2019 total product revenue guidance to $3.6 to $3.7 billion - - Company advancing programs in 5 additional diseases beyond cystic fibrosis - BOSTON --(BUSINESS WIRE)--Jul.
Jul 25, 2019
Vertex Announces Dr. Jeffrey Leiden to Transition to Role of Executive Chairman, Effective April 1, 2020 and Dr. Reshma Kewalramani Appointed as New Chief Executive Officer
BOSTON --(BUSINESS WIRE)--Jul. 25, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that its Board of Directors has approved the planned transition of Chairman, President and Chief Executive Officer Jeffrey Leiden , M.D., Ph.D, into the role of Executive Chairman of the
Jul 22, 2019
Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
-Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations- BOSTON --(BUSINESS WIRE)--Jul. 22, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq:
Jul 17, 2019
Vertex to Announce Second-Quarter 2019 Financial Results on July 31
BOSTON --(BUSINESS WIRE)--Jul. 17, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second quarter 2019 financial results on Wednesday, July 31, 2019 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
Jun 21, 2019
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.
Jun 06, 2019
Vertex Expands into New Disease Areas and Enhances Gene Editing Capabilities Through Expanded Collaboration with CRISPR Therapeutics and Acquisition of Exonics Therapeutics
-Provides Vertex with leading gene editing capabilities to develop novel therapies for Duchenne Muscular Dystrophy and Myotonic Dystrophy Type 1- -CRISPR to receive an upfront payment of $175 million , with potential for additional milestone and royalty payments- -Exonics to be acquired for an
Jun 04, 2019
Vertex to Present Data at ECFS Conference on Potential Impact of Early Treatment and Long-Term Treatment with CFTR Modulators on the Underlying Cause of CF
BOSTON --(BUSINESS WIRE)--Jun. 4, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from six scientific abstracts from the company’s portfolio of cystic fibrosis (CF) medicines will be presented at the 42 nd European Cystic Fibrosis Conference , taking place June
May 30, 2019
Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 14.3 percentage points from baseline through week 24 of treatment compared to placebo (p
May 15, 2019
Vertex and Kymera Therapeutics Establish Strategic Collaboration to Discover and Develop Targeted Protein Degradation Medicines for Serious Diseases
-Multi-year collaboration leveraging Kymera’s proprietary targeted protein degradation platform to develop novel medicines- -Kymera to receive $70 million upfront, including equity investment, and potential additional milestone and royalty payments for up to six programs in the collaboration-
Apr 30, 2019
Vertex Reports First-Quarter 2019 Financial Results
- First-quarter 2019 product revenues of $857 million , a 34% increase compared to $638 million in 2018- - First-quarter 2019 GAAP operating income increased 115% to $277 million ; non-GAAP operating income increased 81% to $377 million - - On track to choose best triple combination regimen in Q2
Apr 30, 2019
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
Apr 16, 2019
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
Apr 12, 2019
Vertex to Announce First-Quarter 2019 Financial Results on April 30
BOSTON --(BUSINESS WIRE)--Apr. 12, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2019 financial results on Tuesday, April 30, 2019 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
Apr 02, 2019
Vertex Appoints Charles Wagner as Chief Financial Officer
BOSTON --(BUSINESS WIRE)--Apr. 2, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the appointment of Charles (Charlie) Wagner as Executive Vice President and Chief Financial Officer (CFO), effective April 10, 2019 . Mr. Wagner will report directly to Vertex Chairman,
Mar 12, 2019
Vertex Receives Approval for SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) in Australia, to Treat the Underlying Cause of Cystic Fibrosis in People aged 12 and Older with Certain CFTR Gene Mutations
-A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis- -First medicine in Australia to treat the underlying cause of cystic fibrosis in patients who have certain mutations that result in residual CFTR function- BOSTON --(BUSINESS
Mar 06, 2019
Two Phase 3 Studies of the Triple Combination of VX-445, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 13.8 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation (F/MF) compared to placebo (p
Feb 25, 2019
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.
Feb 21, 2019
Vertex Appoints Lloyd Carney to its Board of Directors
BOSTON --(BUSINESS WIRE)--Feb. 21, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Lloyd Carney has been appointed to its board of directors as an independent director. Mr. Carney is a prominent technology executive with experience leading innovative, high-growth
Feb 14, 2019
Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission
-Study met primary endpoint with a statistically significant improvement in absolute change in lung clearance index (LCI 2.5 ) through 8 weeks of tezacaftor/ivacaftor treatment- -Tezacaftor in combination with ivacaftor was generally well tolerated and safety data were consistent with previous
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