Skip to Content

News & Events

Press Releases

Press Releases

Date Title and Summary Additional Formats
Toggle Summary Vertex and CRISPR Therapeutics Complete Submission of Rolling Biologics License Applications (BLAs) to the US FDA for exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
-EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review procedure has begun as of January 2023 - BOSTON & ZUG, Switzerland --(BUSINESS WIRE)--Apr. 3, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced
View HTML
Toggle Summary Vertex to Announce First Quarter 2023 Financial Results on May 1
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 .
View HTML
Toggle Summary Vertex to Present at the Bank of America Securities 2023 Health Care Conference on May 9
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 .
View HTML
Toggle Summary Vertex Announces U.S. FDA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 2 Through 5 With Certain Mutations
-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
View HTML
Toggle Summary Vertex Receives CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 1 to <2 Years Old
- 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&nbsp;that can treat the underlying cause of their disease - LONDON – 26/27/28 April 2023 – Vertex Pharmaceuticals (Nasdaq: VRTX)
View HTML
Toggle Summary Vertex Reports First Quarter 2023 Financial Results
— 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
View HTML
Toggle Summary Vertex Announces U.S. FDA Approval for KALYDECO® (ivacaftor) to Treat Eligible Infants With CF Ages 1 Month and Older
-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
View HTML
Toggle Summary Vertex to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference on June 13
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.
View HTML
Toggle Summary FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
- 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 –
View HTML
Toggle Summary Positive Results From Pivotal Trials of exa-cel for Transfusion-Dependent Beta Thalassemia and Severe Sickle Cell Disease Presented at the 2023 Annual European Hematology Association (EHA) Congress
- 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 &amp; ZUG,
View HTML