-In Australia, approximately 1,000 people with CF ages 12 and older have two copies of the F508del mutation- -ORKAMBI reimbursement process already underway in Australia - LONDON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Therapeutic Goods
- With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for a CFTR modulator therapy - LONDON --(BUSINESS WIRE)--Mar. 24, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Australian Therapeutic Goods
-If approved, more than 1,200 children would be newly eligible for a medicine that could treat the underlying cause of their disease- BOSTON --(BUSINESS WIRE)--Sep. 15, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee
- If approved, more than 1,500 children would be eligible for a medicine that can treat the underlying cause of their disease for the first time - LONDON --(BUSINESS WIRE)--Nov. 12, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s
- If approved, people ages 12 years and older who have one copy of the F508del mutation and a gating (F/G) or residual function (F/RF) mutation will now be eligible for triple combination therapy - LONDON --(BUSINESS WIRE)--Mar. 26, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
- If approved, KALYDECO ® will be the first and only medicine approved in Europe to treat the underlying cause of cystic fibrosis in babies as young as 1 month with specific mutations in the CFTR gene - LONDON --(BUSINESS WIRE)--Feb. 23, 2024-- Vertex Pharmaceuticals (Nasdaq: VRTX) today announced
- In Europe, there are approximately 3,400 children ages 6-11 who have two copies of the F508del mutation - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Union Committee for Medicinal Products for Human Use (CHMP) issued a positive
- If approved by the European Commission, nearly 300 children with cystic fibrosis and two copies of the F508del mutation would be eligible for the first time for a medicine that can treat the underlying cause of their disease - LONDON – 26/27/28 April 2023 – Vertex Pharmaceuticals (Nasdaq: VRTX)
- If approved by the European Commission , patients 12 years of age and older with severe sickle cell disease or transfusion-dependent beta thalassemia, for whom hematopoietic stem cell transplantation is appropriate and a human leukocyte antigen matched related donor is not available, would be
-CHMP recommends Marketing Authorization for lumacaftor in combination with ivacaftor for people with cystic fibrosis ages 12 and older with two copies of the F508del mutation- -CHMP recommends Marketing Authorization for ivacaftor for children with cystic fibrosis ages 2 to 5 with 9 gating
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the use of KALYDECO ® (ivacaftor) in people with cystic
- In Europe, there are approximately 3,400 children ages 6-11 who have two copies of the F508del mutation - - Existing reimbursement agreements in countries like Ireland will enable rapid access to ORKAMBI; country-by-country reimbursement processes will now begin in other countries- LONDON
-In Europe, approximately 12,000 people with CF ages 12 and older have two copies of the F508del mutation- -Positive CHMP Opinion was received in September 2015 - -Country-by-country reimbursement process will now begin- LONDON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
-In Europe, approximately 250 people ages 6 and older have one of 8 additional gating mutations- -KALYDECO is the first medicine to treat the underlying cause of CF in people with specific non-G551D gating mutations- EYSINS, Switzerland --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated
- European Commission approval comes two months after positive CHMP opinion - GENEVA --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has approved KALYDECO TM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who
- If approved, KALYDECO ® (ivacaftor) will be the first and only medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation, as young as 6 months of age - LONDON --(BUSINESS WIRE)--May 1, 2020-- Vertex
- If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic fibrosis for children this young - LONDON --(BUSINESS WIRE)--Oct. 18, 2019-- Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for
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
-In Europe, approximately 250 people ages 6 and older have one of 8 additional gating mutations- -KALYDECO is the first medicine to treat the underlying cause of CF in people with non-G551D gating mutations- EYSINS, Switzerland --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
- Global studies showed significant and sustained improvements in lung function and other measures of disease among people with a specific genetic mutation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Committee for
- 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
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
- European Commission approves expanded use of ivacaftor in children with cystic fibrosis ages 2 to 5 who have one of 9 gating mutations; approximately 125 children ages 2 to 5 have one of the approved gating mutations in Europe - - European Commission approves expanded use of ivacaftor in people
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO ® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance
BOSTON --(BUSINESS WIRE)--Nov. 13, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it has been notified of an unsolicited “mini-tender” offer dated November 9, 2020 , made by TRC Capital Investment Corporation , an Ontario, Canada , corporation to purchase up to
-Hepatitis C: Regulatory agencies in U.S., Europe and Canada to provide accelerated reviews of telaprevir applications- -Cystic Fibrosis: First Phase 3 registration data for VX-770 expected in first quarter 2011; potential regulatory submissions in the U.S. and E.U.
-Hepatitis C: FDA decision on NDA for INCIVEK TM (telaprevir) expected this month- -Cystic Fibrosis: Phase 3 program for VX-770 supports applications for approval in U.S. and E.U., with NDA and MAA planned for second half of 2011- -Financial: Vertex enters second quarter with more than $820 million
-Approximately 600 people with cystic fibrosis have started treatment with KALYDECO since approval on January 31 - -Multiple ongoing clinical trials to generate data beginning in second quarter, including study of KALYDECO combined with VX-809 in cystic fibrosis and first data for Alios nucleotides
-First quarter 2013 total revenues of $328 million , including net product revenues of $206 million for INCIVEK in hepatitis C and $62 million for KALYDECO in cystic fibrosis- -Cystic fibrosis: Enrollment ongoing in Phase 3 program for VX-809 in combination with ivacaftor for people with two copies
-Net product revenues of $100 million for KALYDECO in cystic fibrosis- -Cash, cash equivalents and marketable securities of $1.32 billion on March 31, 2014 - -Six-month dosing period complete for Phase 3 TRAFFIC and TRANSPORT studies of lumacaftor in combination with ivacaftor for people with CF
-First quarter 2015 total revenues of $139 million , including net product revenues of $130 million for KALYDECO ® (ivacaftor) in cystic fibrosis- -Cash, cash equivalents and marketable securities of approximately $1.2 billion on March 31, 2015 - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
-First quarter 2016 cystic fibrosis product revenues of $394 million ; $223 million for ORKAMBI ® (lumacaftor/ivacaftor) and $171 million for KALYDECO ® (ivacaftor)- -Provides 2016 guidance for ORKAMBI product revenues of $1.0 to $1.1 billion ; increases 2016 guidance for KALYDECO product revenues
— Product revenues of $2.10 billion , a 22% increase compared to Q1 2021 — — Company reiterates full year 2022 product revenue guidance of $8.4 to $8.6 billion — — Mid- and late-stage clinical pipeline now spans 6 disease areas — BOSTON --(BUSINESS WIRE)--May 5, 2022-- Vertex Pharmaceuticals
— Product revenue of $2.37 billion , a 13% increase compared to Q1 2022 — — Company reiterates full year 2023 financial guidance, including product revenue guidance of $9.55 to $9.7 billion — — TRIKAFTA approved in U.S. for children with cystic fibrosis 2 to 5 years of age — — Pipeline advancement
-First-quarter 2017 cystic fibrosis product revenues of $481 million ; $295 million for ORKAMBI and $186 million for KALYDECO- -Company reiterates 2017 guidance for ORKAMBI product revenues of $1.1 to $1.3 billion and increases 2017 guidance for KALYDECO product revenues to $710 to $730 million -
-First-quarter 2018 total CF product revenues of $638 million , a 33% increase compared to $481 million in the first quarter of 2017- -Company reiterates full-year 2018 total CF product revenue guidance of $2.65 to $2.80 billion and combined non-GAAP R&D and SG&A expense guidance of $1.50 to $1.55
- 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
-Product revenues of $1.72 billion , a 14% increase compared to Q1 2020- - Company advancing clinical programs in six additional diseases beyond cystic fibrosis- -Multiple Phase 2 proof-of-concept study results expected in 2021 - BOSTON --(BUSINESS WIRE)--Apr.
-Full year product revenues of $7.57 billion , a 22% increase compared to full year 2020- -Company provides full year 2022 product revenue guidance of $8.4 to $8.6 billion - - Advancing broad clinical pipeline across six disease areas; multiple programs in mid- and late-stage development with
— Full year product revenue of $9.87 billion , an 11% increase compared to full year 2022 — — Company provides full year 2024 product revenue guidance of $10.55 to $10.75 billion — — CASGEVY TM approved in the U.S. , Great Britain , the Kingdom of Saudi Arabia and Bahrain — — Vertex on track to
— Full year product revenue of $8.93 billion , an 18% increase compared to full year 2021 — — Full year GAAP and non-GAAP net income increased 42% and 53%, respectively, versus 2021— — Company provides full year 2023 product revenue guidance of $9.55 to $9.7 billion — — Exa-cel regulatory
-Successful launch of INCIVEK (telaprevir) for hepatitis C and recent approval of KALYDECO (ivacaftor) for cystic fibrosis position Vertex for continued growth, earnings and cashflow- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated
-2013 investment focused on key development programs in cystic fibrosis, hepatitis C and autoimmune diseases- -Full-year 2012 revenues of $1.53 billion , including net product revenues of $1.16 billion for INCIVEK in hepatitis C and $171.6 million for KALYDECO in cystic fibrosis- -Company ends 2012
-Full-year 2013 total revenues of $1.21 billion , including net product revenues of $371.3 million for KALYDECO in cystic fibrosis and $466.3 million for INCIVEK in hepatitis C- -Cash, cash equivalents and marketable securities of approximately $1.47 billion on December 31, 2013- -Company expects
-Full-year 2014 total revenues of $580 million , including net product revenues of $464 million for KALYDECO in cystic fibrosis- -Cash, cash equivalents and marketable securities of approximately $1.4 billion on December 31, 2014 - -Company expects total 2015 KALYDECO net revenues of $560 to $580
-Full-year 2015 total non-GAAP revenues of $1.01 billion , including net product revenues of $351 million for ORKAMBI ® (lumacaftor/ivacaftor) and $632 million for KALYDECO ® (ivacaftor) in cystic fibrosis- -Vertex reiterates 2016 financial guidance for KALYDECO net product revenues of $670 to $690
-2016 total CF product revenues of $1.68 billion compared to $982 million in 2015; $980 million for ORKAMBI and $703 million for KALYDECO- -Fourth-quarter 2016 total CF product revenues of $454 million ; $277 million for ORKAMBI and $177 million for KALYDECO- -Company reiterates 2017 financial
-Total 2017 CF product revenues of $2.17 billion , a 29% increase compared to $1.68 billion in 2016; 2017 KALYDECO revenues of $845 million and 2017 ORKAMBI revenues of $1.32 billion - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated
