- 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
BOSTON --(BUSINESS WIRE)--Nov. 2, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data on TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), which can treat the underlying cause of cystic fibrosis (CF) in ~90% of people with the disease, will be presented at
BOSTON --(BUSINESS WIRE)--Oct. 26, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced management participation in two upcoming investor conferences. Charles Wagner , Executive Vice President and Chief Financial Officer, and David Altshuler , M.D., Ph.D., Executive Vice
BOSTON --(BUSINESS WIRE)--Oct. 10, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2023 financial results on Monday, November 6, 2023 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
BOSTON --(BUSINESS WIRE)--Oct. 5, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Michel Lagarde has been appointed to its Board of Directors as an independent director. Mr. Lagarde is a senior health care and business leader with global expertise, currently serving
- All patients treated with VX-880 in Parts A and B have follow-up data beyond Day 90 and have demonstrated islet cell engraftment and glucose-responsive insulin production - - All patients showed improvement across all measures of glucose control, including decreases in HbA1c, increases in blood
-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
- Paul Negulescu , Fredrick Van Goor and Sabine Hadida receive Breakthrough Prize for developing transformative medicines for people with cystic fibrosis – BOSTON --(BUSINESS WIRE)--Sep. 14, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that three of its researchers have
BOSTON --(BUSINESS WIRE)--Aug. 30, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced management participation in the Morgan Stanley 21 st Annual Global Healthcare Conference. Dr. Reshma Kewalramani , Chief Executive Officer and President, and Charles Wagner , Executive Vice
BOSTON --(BUSINESS WIRE)--Aug. 29, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that E. Morrey Atkinson , Ph.D., has been appointed Executive Vice President, Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations, effective
- First published manuscript of VX-548 preclinical and clinical trial results in a peer-reviewed journal - BOSTON --(BUSINESS WIRE)--Aug. 3, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced publication in the New England Journal of Medicine (NEJM) of preclinical data and
— Product revenue of $2.49 billion , a 14% increase compared to Q2 2022 — — Company raises full year 2023 product revenue guidance to $9.7 to $9.8 billion — — FDA has accepted the exa-cel BLAs in both severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT); Priority Review
-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
BOSTON --(BUSINESS WIRE)--Jun. 30, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second quarter 2023 financial results on Tuesday, August 1, 2023 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
- Following positive Phase 1/2 results in Vertex’s VX-880 program, Vertex and Lonza announce strategic manufacturing collaboration - - Dedicated large-scale facility will support commercial production of Vertex’s T1D cell therapy portfolio - - Approximately 300 new jobs anticipated at Lonza
– All six patients treated with VX-880 engrafted islet cells, produced endogenous insulin (C-peptide) and had improved glycemic control while reducing or eliminating insulin use – – The two patients with at least one year of follow-up met the criteria for the primary endpoint of elimination of
-Interim results of largest real-world study of TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) showed sustained improvement in lung function, reduction in pulmonary exacerbations frequency and lower rates of lung transplant and death for people with cystic fibrosis- - Twelve
- Both trials met the primary and key secondary endpoints at the pre-specified interim analysis - - Data continue to demonstrate transformative and durable benefit - - Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant - BOSTON & ZUG,
- 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 –
BOSTON --(BUSINESS WIRE)--May 30, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced management participation in the Goldman Sachs 44 th Annual Global Healthcare Conference. Dr. Reshma Kewalramani , Chief Executive Officer and President, and Stuart A.
-First and only CFTR modulator approved for this age group- BOSTON --(BUSINESS WIRE)--May 3, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO ® (ivacaftor) for use in children with cystic fibrosis (CF) ages 1
— 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
- 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)
-About 900 children with cystic fibrosis will now have a medicine to treat the underlying cause of their disease for the first time- BOSTON --(BUSINESS WIRE)--Apr. 26, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved the
BOSTON --(BUSINESS WIRE)--Apr. 25, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the Bank of America Securities 2023 Health Care Conference on Tuesday, May 9, 2023 at 9:20 a.m. PT / 12:20 p.m. ET .
BOSTON --(BUSINESS WIRE)--Apr. 10, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2023 financial results on Monday, May 1, 2023 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
