News & Events

Date Title and Summary Additional Formats
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 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
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Toggle Summary 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:
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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 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
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Toggle Summary 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
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Toggle Summary 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
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Toggle Summary 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-
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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 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 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,
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Toggle Summary 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
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Toggle Summary 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
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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 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
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Toggle Summary 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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Toggle Summary Health Canada Grants Market Authorization for KALYDECO® (ivacaftor) in Children Ages 12 to <24 months with Certain Mutations in the CFTR Gene
-KALYDECO is the first and only approved medicine in Canada to treat the underlying cause of cystic fibrosis in these young patients- BOSTON --(BUSINESS WIRE)--Jan. 28, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has granted Market Authorization for
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Toggle Summary Vertex Announces Departure of Ian Smith, Names Interim CFO
BOSTON --(BUSINESS WIRE)--Jan. 23, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Ian Smith has been terminated as Chief Operating Officer and interim Chief Financial Officer (CFO) effective immediately. Mr. Smith’s termination is the result of personal behavior that
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Toggle Summary Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 children aged 2 to 5 with two copies of the F508del mutation LONDON --(BUSINESS WIRE)--Jan. 21, 2019-- Vertex Pharmaceuticals (Europe) Limited today
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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 Vertex and Arbor Biotechnologies Establish Collaboration to Discover Novel Proteins to Advance Discovery of Gene-Editing Therapies
-Multi-year research collaboration funded by Vertex using Arbor’s proprietary research platform to enhance efforts in developing gene-editing therapies in five diseases- -Arbor to receive up-front cash payment and convertible note investment, research funding, and potential for additional
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Toggle Summary Vertex Announces it will Submit Cystic Fibrosis Medicines ORKAMBI® (lumacaftor/ivacaftor) as well as SYMKEVI® (tezacaftor/ivacaftor) to be Used in Combination with ivacaftor, to the Scottish Medicines Consortium for Appraisal
- 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
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Toggle Summary Vertex Announces Positive Phase 2 Data in Third Proof-of-Concept Study with the NaV1.8 Inhibitor VX-150
-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
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Toggle Summary Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
- ORKAMBI is the first medicine in Canada to treat the underlying cause of CF in young children with two copies of the F508del mutation - BOSTON --(BUSINESS WIRE)--Dec. 13, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that Health Canada has granted Market Authorization
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) to Treat Patients with Cystic Fibrosis Aged 12 to <24 months with Certain Mutations in the CFTR Gene
Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in these young patients LONDON --(BUSINESS WIRE)--Nov. 29, 2018-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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Toggle Summary Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 14.0 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation compared to placebo (p
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Toggle Summary Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
- If approved, lumacaftor/ivacaftor will be the first medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 young children with two copies of the F508del mutation - LONDON --(BUSINESS WIRE)--Nov. 16, 2018-- Vertex Pharmaceuticals (Europe) Limited today
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Toggle Summary Vertex Announces European Authorization for Third Cystic Fibrosis Medicine SYMKEVI® (tezacaftor/ivacaftor), to be used in combination with ivacaftor (KALYDECO®), for People with CF Aged 12 and Older with Certain Mutations in the CFTR gene
- A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis - - First medicine in the EU to treat the CFTR protein defect in patients who have one copy of the F508del mutation and one copy of one of 14 mutations that result in residual
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene
If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic fibrosis for these young children LONDON --(BUSINESS WIRE)--Oct. 19, 2018-- Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal
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Toggle Summary Vertex Data Presented at North American Cystic Fibrosis Conference (NACFC) Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating the Underlying Cause of Cystic Fibrosis
- Phase 2 results of VX-659 and VX-445 triple combination regimens concurrently published in The New England Journal of Medicine - - Phase 3 ARRIVAL data support treating the underlying cause of cystic fibrosis with KALYDECO ® (ivacaftor) as early as six months of age - - Patient-reported outcomes
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Toggle Summary Vertex Announces Access Contract in Denmark for Current and Future Cystic Fibrosis Medicines
- First-of-its-kind contract with the Danish pharmaceutical and procurement organization, Amgros, is effective from today - - Vertex also announces reimbursement in Austria for ORKAMBI ® (lumacaftor/ivacaftor) to treat patients ages 6 through 11 with two copies of the F508del mutation - LONDON
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Toggle Summary Vertex Appoints Katharine Jensen as Head of Corporate Social Responsibility
-- Ms. Jensen to oversee global CSR efforts and lead The Vertex Foundation -- BOSTON --(BUSINESS WIRE)--Sep. 10, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Katharine Jensen has been appointed Head of Corporate Social Responsibility (CSR). In this role, Ms.
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Toggle Summary Vertex Completes Enrollment of Two Phase 3 Studies of VX-659 in Triple Combination with Tezacaftor and Ivacaftor for the Treatment of Cystic Fibrosis
-Data expected in late 2018 from Phase 3 studies of VX-659, tezacaftor and ivacaftor in people with one F508del mutation and one minimal function mutation and in people with two F508del mutations- -Enrollment of two Phase 3 studies of VX-445 in triple combination with tezacaftor and ivacaftor
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Toggle Summary Vertex Announces Reimbursement Agreement in Australia for ORKAMBI® (lumacaftor/ivacaftor) for People with Cystic Fibrosis Ages Six Years and Older with Two Copies of the F508del Mutation
- Approximately 1,300 patients in Australia join the thousands of patients worldwide who already have access to lumacaftor/ivacaftor - - A pathway to access for future Vertex CF medicine, tezacaftor/ivacaftor, has also been established - LONDON --(BUSINESS WIRE)--Sep.
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Toggle Summary Vertex and Genomics plc Establish Collaboration to Use Human Genetics and Data Science to Advance Discovery of Precision Medicines
Multi-year collaboration combines expertise in genomics, machine learning and drug discovery to identify novel targets for innovative medicines BOSTON &amp; OXFORD, United Kingdom --(BUSINESS WIRE)--Aug. 30, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Genomics plc today announced a
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Toggle Summary Vertex Appoints Ludovic Fenaux as Senior Vice President, International Commercial Operations
– Ludovic Fenaux to lead Vertex’s expanding International organization – – Simon Bedson announces retirement – LONDON --(BUSINESS WIRE)--Aug. 23, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Ludovic Fenaux has been appointed Senior Vice President, International
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Toggle Summary Vertex Receives a Positive PBAC Recommendation for Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) to Treat Australians Ages Six and Over with Cystic Fibrosis and Two Copies of the F508del Mutation
- PBAC recommendation moves approximately 1,300 patients in Australia closer to access to lumacaftor/ivacaftor and Vertex is now working with the Australian Government to finalize a reimbursement agreement as soon as possible - LONDON --(BUSINESS WIRE)--Aug.
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Toggle Summary Vertex Awards Two College Students Full Scholarships to the University of Massachusetts
-- Boston Public High School Students Nora Nguyen and Sonny Mei Receive Vertex Science Leaders Scholarship to Pursue STEAM Degrees at UMass -- BOSTON --(BUSINESS WIRE)--Aug. 16, 2018-- Vertex today announced the recipients of the annual Vertex Science Leaders Scholarship, a four-year, full-ride
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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 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 Vertex Receives European CHMP Positive Opinion for SYMKEVI® (tezacaftor/ivacaftor) for People with Cystic Fibrosis Aged 12 and Older with Certain Mutations in the CFTR Gene
If approved, SYMKEVI ® (tezacaftor/ivacaftor) will be Vertex’s third medicine to treat the CFTR protein defect in patients with cystic fibrosis – a rare life-shortening disease LONDON --(BUSINESS WIRE)--Jul. 27, 2018-- Vertex Pharmaceuticals (Europe) Limited , today announced that the European
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Toggle Summary Health Canada Approves PrSYMDEKO™ (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- -Approximately 2,000 people in Canada are ages 12 and older and have two copies of the F508del mutation or at least one mutation in the CF gene that is responsive to treatment with SYMDEKO- BOSTON --(BUSINESS WIRE)--Jun.
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Toggle Summary Vertex’s Paul Negulescu Awarded the Warren Alpert Foundation Prize for Pioneering Discoveries in Cystic Fibrosis
BOSTON --(BUSINESS WIRE)--Jun. 21, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Senior Vice President Paul Negulescu has been named one of the winners of this year’s Warren Alpert Foundation Prize for “transformative discoveries in the fields of genetics,
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Toggle Summary Vertex Opens Expanded Research Site in San Diego
BOSTON --(BUSINESS WIRE)--Jun. 18, 2018-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced the opening of its new 170,000 square foot research facility in Torrey Pines , San Diego . The new site represents a significant expansion of the Company’s research presence in the area, and
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Toggle Summary Vertex Announces Long-Term Access Agreement in Sweden for Cystic Fibrosis Medicine ORKAMBI® (lumacaftor/ivacaftor)
- 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.
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Toggle Summary The Vertex Foundation and Employees Donate $1 Million Through Matching Gift Program
BOSTON --(BUSINESS WIRE)--Jun. 14, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Vertex employees and The Vertex Foundation have together donated over $1 million through the Company’s new dollar-for-dollar matching gift program.
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Toggle Summary Vertex Data Presented at European Cystic Fibrosis Society (ECFS) Conference Demonstrate Early and Long-Term Disease-Modifying Potential of Treating the Underlying Cause of CF
- Data from KALYDECO ® (ivacaftor) studies show the potential to modify the long-term progression of the disease - - Interim analysis of the ongoing extension study of tezacaftor/ivacaftor combination (approved in the U.S. as SYMDEKO TM ) continues to demonstrate consistent safety and sustained
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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 Vertex Awards $400,000 in Scholarships to People Living with Cystic Fibrosis and Their Immediate Family Members
All in for CF Scholarship Program Doubles to Help 80 Recipients Pursue Higher Education BOSTON --(BUSINESS WIRE)--May 1, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the recipients of scholarships as part of its second All in for CF Scholarship program.
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Toggle Summary Vertex Initiates Phase 3 Studies of VX-445, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis
-VX-445 triple combination regimen is the second of two different triple combination regimens to enter Phase 3 development in 2018- -Phase 3 study in approximately 360 patients with one F508del mutation and one minimal function mutation designed to support New Drug Application based on 4-week
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