- ALYFTREK ™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies - - In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV 1 and further decreased sweat chloride compared
- Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time - BOSTON --(BUSINESS WIRE)--Dec. 20, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S.
– Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) – – Placebo arm showed similar within-group
- Data from long-term follow-up of patients in clinical trials further demonstrate durability of the transformative benefits of CASGEVY™ - - Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant - - Vertex provides update on progress in bringing
— Product revenue of $2.77 billion , a 12% increase compared to Q3 2023 — — Raising full-year product revenue guidance to $10.8 billion to $10.9 billion — — Preparing for two potential near-term launches: vanzacaftor triple in CF and suzetrigine (VX-548) for moderate-to-severe acute pain — —
BOSTON --(BUSINESS WIRE)--Oct. 29, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced management participation in two upcoming investor conferences. Dr. Reshma Kewalramani , Chief Executive Officer and President, will participate in a fireside chat at the Guggenheim Inaugural
- New data on povetacicept 80 mg SC Q4 weeks in IgA nephropathy shows mean UPCR reduction from baseline of 66% observed at 48 weeks, associated with stable renal function (eGFR) and 63% achieving clinical remission -- - First proteinuria data on povetacicept in primary membranous nephropathy shows
-- Phase 3 abstract selected for presentation in “Best Abstract” session -- BOSTON --(BUSINESS WIRE)--Oct. 18, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the company will present its pivotal Phase 3 data on suzetrigine, an investigational, oral, highly selective
BOSTON --(BUSINESS WIRE)--Oct. 10, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2024 financial results on Monday, November 4, 2024 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
– Phase 3 data on investigational vanza triple demonstrates non-inferiority to TRIKAFTA ® in ppFEV 1 and further improvement of CFTR function as measured by sweat chloride – – Real-world evidence and clinical studies of TRIKAFTA ® continue to show sustained long-term benefits including
BOSTON --(BUSINESS WIRE)--Aug. 22, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced management participation in two upcoming investor conferences. Dr. Reshma Kewalramani , Chief Executive Officer and President, and Charles Wagner , Executive Vice President and Chief
- Eligible transfusion-dependent beta thalassemia (TDT) patients in England will be able to access the therapy from today - - CASGEVY is one of the first medicines funded by NHS England’s Innovative Medicines Fund - LONDON --(BUSINESS WIRE)--Aug. 7, 2024-- Vertex Pharmaceuticals (Nasdaq: VRTX)
— Product revenue of $2.65 billion , a 6% increase compared to Q2 2023 — — Company raises full year product revenue guidance to $10.65 to $10.85 billion — — FDA accepted NDA for vanzacaftor triple in CF with Priority Review and PDUFA target action date of January 2, 2025 ; additionally, MAA
– FDA grants priority review and assigns a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025 – – Suzetrigine, an investigational non-opioid pain signal inhibitor, has the potential to treat millions of patients who suffer from moderate-to-severe acute pain each year –
- Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 – - EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA) BOSTON --(BUSINESS WIRE)--Jul.
BOSTON --(BUSINESS WIRE)--Jul. 1, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second quarter 2024 financial results on Thursday, August 1, 2024 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
– All 12 patients who received the full dose of VX-880 as a single infusion demonstrated islet cell engraftment and glucose-responsive insulin production by Day 90 – – All patients achieved ADA -recommended target HbA1c levels 70% time-in-range (70-180 mg/dL), and 11 of 12 patients
- Results from CLIMB-111, -121 and -131 accepted for oral presentation - - Data from these trials, with the longest follow-up of more than five years, demonstrate transformative, consistent and durable benefit of CASGEVY™ - - Safety profile consistent with busulfan conditioning and autologous
- Results from a randomized, placebo-controlled study of TRIKAFTA ® in people with cystic fibrosis with rare, non- F508del CFTR mutations showed statistically significant and clinically meaningful improvements in the primary and all secondary endpoints - - Interim results of largest real-world
BOSTON --(BUSINESS WIRE)--May 22, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced management participation in two upcoming investor conferences. Dr. Reshma Kewalramani , Chief Executive Officer and President, will present at the William Blair 44 th Annual Growth Stock
BOSTON --(BUSINESS WIRE)--May 15, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Jennifer Schneider , M.D., M.S., has been elected to its Board of Directors as an independent director. Dr. Schneider has more than two decades of experience in the health care industry
— Product revenue of $2.69 billion , a 13% increase compared to Q1 2023; reiterated full year 2024 financial guidance, including product revenue guidance of $10.55 to $10.75 billion — — Submitted NDA and MAA filings for vanzacaftor triple in CF to FDA and EMA, respectively — — Initiated rolling NDA
- KALYDECO ® is the first and only medicine approved in the EU in this age group to treat the underlying cause of cystic fibrosis for specific mutations in the CFTR gene - LONDON --(BUSINESS WIRE)--Apr. 26, 2024-- Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European
Vertex obtains an exclusive license to TreeFrog's C-Stem TM manufacturing technology in type 1 diabetes TreeFrog and Vertex to collaborate on scale-up of fully differentiated, insulin-producing pancreatic islet cells BOSTON and BORDEAUX, France , April 23, 2024 /PRNewswire/ -- Vertex
– Rolling submission for suzetrigine moderate-to-severe acute pain NDA granted by FDA; first module submitted and on track to complete filing this quarter – – Successful completion of end-of-phase 2 FDA meeting for pain associated with diabetic peripheral neuropathy (DPN); Phase 3 program to
- Alpine is a clinical stage biotechnology company focused on discovering and developing innovative, protein-based immunotherapies - - Alpine’s lead product, povetacicept, demonstrated best-in-class potential in patients with IgA nephropathy (IgAN); Phase 3 to initiate in H2 2024 - - Povetacicept
BOSTON --(BUSINESS WIRE)--Apr. 9, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2024 financial results on Monday, May 6, 2024 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
– 45 mg once daily oral dose selected for Phase 3 – – Results support trial expansion to lower age group and study will now include adolescents ages 10-17 years – – If positive, pre-planned interim analysis at Week 48 may serve as the basis for accelerated approval in the U.S.
– ADPKD is the most common inherited kidney disease, with no treatments currently available that address the underlying cause of disease – – Vertex to initiate a Phase 1 clinical trial in healthy volunteers this month – – ADPKD is Vertex’s 10th disease area in the clinic, further expanding the
- 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
BOSTON --(BUSINESS WIRE)--Feb. 20, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Charles Wagner , Executive Vice President and Chief Financial Officer, and David Altshuler , M.D., Ph.D., Executive Vice President, Global Research , and Chief Scientific Officer, will
- Over 8,000 patients 12 years of age and older with severe sickle cell disease or transfusion-dependent beta thalassemia may be eligible for treatment - LONDON --(BUSINESS WIRE)--Feb. 13, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has
— 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
– Treatment with the once-daily vanza triple CFTR modulator regimen met all primary and key secondary endpoints in two randomized controlled trials in people with CF ages 12 years and older – – Results were more pronounced in the single-arm study in children ages 6 to 11 years, demonstrating the
– Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials – – Treatment with VX-548 was also shown to be effective in
BOSTON --(BUSINESS WIRE)--Jan. 17, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its fourth quarter and full year 2023 financial results on Monday, February 5, 2024 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
- Approximately 1,000 patients in the U.S. 12 years of age and older are now eligible for this one-time treatment - BOSTON --(BUSINESS WIRE)--Jan. 16, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™
- CASGEVY™ is first medicine ever to be evaluated through the SFDA’s Breakthrough Medicines Program - - First treatment center in Saudi Arabia has been activated - BOSTON --(BUSINESS WIRE)--Jan. 9, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the Saudi Food and
BOSTON --(BUSINESS WIRE)--Jan. 7, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced multiple program updates ahead of upcoming investor meetings in January, including the company’s scheduled webcast from the 42 nd Annual J.P. Morgan Healthcare Conference on Monday, January
BOSTON --(BUSINESS WIRE)--Dec. 18, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Dr. Reshma Kewalramani , Chief Executive Officer and President, will present at the 42 nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 11:15 a.m.
- 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
– Treatment with the NaV1.8 inhibitor VX-548 led to statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the Numeric Pain Rating Scale (NPRS) – – VX-548 was generally well tolerated – – Vertex plans to advance VX-548 into pivotal
- Longer-term follow-up data demonstrate consistent and durable response to treatment - BOSTON --(BUSINESS WIRE)--Dec. 11, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced two oral presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition from
– First-ever approval of a CRISPR-based gene-editing therapy in the U.S. – – Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment – – Multiple authorized treatment centers activated – BOSTON & ZUG, Switzerland
BOSTON --(BUSINESS WIRE)--Dec. 5, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Nancy Thornberry has been appointed to its Board of Directors as an independent director. Ms. Thornberry has more than 35 years of experience in the pharmaceutical and biotech
-Application to add ~200 non-F508del CFTR mutations to the KAFTRIO ® license- -If approved, ~2,800 people with cystic fibrosis in the European Union ages 2 and above could receive a medicine that treats the underlying cause of their disease for the first time- LONDON --(BUSINESS WIRE)--Nov.
-More than 1,200 children are newly eligible for a medicine that could treat the underlying cause of their disease- BOSTON --(BUSINESS WIRE)--Nov. 23, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval for the label expansion
- First regulatory authorization of a CRISPR-based gene-editing therapy in the world – - CASGEVY is indicated for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises who have the βS/βS, βS/β+ or βS/β0 genotype, for whom hematopoietic
— Product revenue of $2.48 billion , a 6% increase compared to Q3 2022 — — Company raises full year 2023 product revenue guidance to approximately $9.85 billion — — U.S. FDA Advisory Committee meeting for exa-cel in SCD completed; PDUFA date for exa-cel in SCD is December 8, 2023 — — Pipeline
- New data including longer duration follow-up from SCD and TDT pivotal trials accepted for oral presentation – - Five additional abstracts accepted for poster presentation - BOSTON --(BUSINESS WIRE)--Nov. 2, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that seven
