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Vertex Pharmaceuticals Inc (VRTX.OQ)

VRTX.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Vertex Receives European CHMP Positive Opinion For KALYDECO (Ivacaftor)
Friday, 19 Oct 2018 

Oct 19 (Reuters) - Vertex Pharmaceuticals (Europe) Limited::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.VERTEX PHARMACEUTICALS (EUROPE) LIMITED - SUBMISSION FOR KALYDECO (IVACAFTOR) SUPPORTED BY DATA FROM CO'S ONGOING PHASE 3 OPEN-LABEL SAFETY STUDY.  Full Article

Vertex Completes Enrollment Of Two Phase 3 Studies Of Vx-659 In Triple Combination With Tezacaftor And Ivacaftor For The Treatment Of Cystic Fibrosis
Thursday, 6 Sep 2018 

Sept 6 (Reuters) - Vertex Pharmaceuticals Inc ::VERTEX COMPLETES ENROLLMENT OF TWO PHASE 3 STUDIES OF VX-659 IN TRIPLE COMBINATION WITH TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS.VERTEX PHARMACEUTICALS INC - DATA EXPECTED IN LATE 2018 FROM PHASE 3 STUDIES OF VX-659, TEZACAFTOR AND IVACAFTOR.VERTEX PHARMACEUTICALS INC - DATA FOR BOTH STUDIES OF VX-445, TEZACAFTOR AND IVACAFTOR EXPECTED IN Q1 OF 2019.VERTEX PHARMACEUTICALS - PLANS TO EVALUATE VX-659, VX-445 TRIPLE COMBINATION DATA TO CHOOSE BEST REGIMEN TO SUBMIT FOR POTENTIAL REGULATORY APPROVAL.VERTEX PHARMACEUTICALS - EXPECTS TO COMPLETE ENROLLMENT IN TWO PHASE 3 STUDIES OF VX-445 IN TRIPLE COMBINATION WITH TEZACAFTOR, IVACAFTOR IN Q4 2018.  Full Article

CRISPR And Vertex Provide Update On FDA Review Of Investigational NDA
Wednesday, 30 May 2018 

May 30 (Reuters) - CRISPR Therapeutics AG ::CRISPR THERAPEUTICS AND VERTEX PROVIDE UPDATE ON FDA REVIEW OF INVESTIGATIONAL NEW DRUG APPLICATION FOR CTX001 FOR THE TREATMENT OF SICKLE CELL DISEASE.CRISPR THERAPEUTICS-PLANNED INITIATION OF PHASE 1/2 TRIAL OF CTX001 IN EUROPE IN ADULT PATIENTS WITH TRANSFUSION DEPENDENT Β-THALASSEMIA IS UNCHANGED.CRISPR THERAPEUTICS AG - U.S FDA HAS PLACED A CLINICAL HOLD ON IND FOR CTX001 FOR TREATMENT OF SICKLE CELL DISEASE.CRISPR THERAPEUTICS AG - COMPANIES EXPECT TO INITIATE PHASE 1/2 TRIAL OF CTX001 IN SECOND HALF OF 2018.  Full Article

Vertex, CRISPR Therapeutics To Co-Develop CTX001 As CRISPR/Cas9 Gene Edited Treatment
Tuesday, 12 Dec 2017 

Dec 12 (Reuters) - Vertex Pharmaceuticals Inc ::VERTEX AND CRISPR THERAPEUTICS TO CO-DEVELOP AND CO-COMMERCIALIZE CTX001 AS CRISPR/CAS9 GENE EDITED TREATMENT FOR SICKLE CELL DISEASE AND Β-THALASSEMIA.VERTEX PHARMACEUTICALS INC - VERTEX SELECTS CTX001 AS FIRST GENE EDITED TREATMENT TO BE DEVELOPED AS PART OF COLLABORATION WITH CRISPR THERAPEUTICS.VERTEX PHARMACEUTICALS - TRIAL APPLICATION FOR CTX001 SUBMITTED IN EUROPE TO SUPPORT INITIATION OF PHASE 1/2 CLINICAL STUDY IN Β-THALASSEMIA IN 2018.VERTEX PHARMACEUTICALS - IND APPLICATION PLANNED FOR SUBMISSION IN 2018 TO SUPPORT INITIATION OF A PHASE 1/2 TRIAL IN SICKLE CELL DISEASE FOR CTX001.  Full Article

Vertex Announces Positive Results From Open-Label Phase 3 Study Of KALYDECO(ivacaftor)
Thursday, 7 Dec 2017 

Dec 7 (Reuters) - Vertex Pharmaceuticals Inc ::VERTEX ANNOUNCES POSITIVE RESULTS FROM OPEN-LABEL PHASE 3 STUDY OF KALYDECO® (IVACAFTOR) IN CHILDREN WITH CYSTIC FIBROSIS AGES 1 TO 2 YEARS.VERTEX PHARMACEUTICALS - KALYDECO​ ‍STUDY MET PRIMARY SAFETY ENDPOINT, SHOWED IMPROVEMENTS ACROSS MULTIPLE ENDPOINTS.VERTEX PHARMACEUTICALS - ‍ARRIVAL STUDY GENERALLY WELL TOLERATED, SAFETY DATA WERE CONSISTENT WITH THOSE SEEN IN PREVIOUS PHASE 3 STUDIES OF IVACAFTOR​.VERTEX PHARMACEUTICALS INC - ‍VERTEX PLANS TO SUBMIT APPLICATIONS FOR IVACAFTOR TO FDA AND EMA IN Q1 OF 2018​.  Full Article

Vertex reports Q3 non-GAAP earnings per share $0.53
Wednesday, 25 Oct 2017 

Oct 25 (Reuters) - Vertex Pharmaceuticals Inc :Vertex reports third-quarter 2017 financial results.Q3 non-GAAP earnings per share $0.53.Q3 GAAP loss per share $0.41.Q3 earnings per share view $0.31 -- Thomson Reuters I/B/E/S.Vertex Pharmaceuticals Inc says ‍third-quarter 2017 cystic fibrosis product revenues of $550 million, up 34% versus Q3 2016​.Says ‍increased its total 2017 CF product revenue guidance, including ORKAMBI and KALYDECO revenue guidance​.Vertex Pharmaceuticals Inc qtrly ‍product revenues for ORKAMBI $336 million and $213 million for KALYDECO​.Says ‍reiterated its 2017 combined GAAP and non-GAAP research and development and SG&A expense guidance​.Says ‍now expects total 2017 CF product revenues of $2.10 to $2.15 billion​.Vertex Pharmaceuticals Inc ‍increases FY ORKAMBI revenue guidance to $1.29 to $1.32 billion and KALYDECO revenue guidance to $810 to $830 million​.  Full Article

Vertex Pharmaceuticals says FTC requested for additional information on pending acquisition from Concert Pharmaceuticals
Monday, 22 May 2017 

May 22 (Reuters) - Concert Pharmaceuticals Inc :Vertex Pharmaceuticals says on May 19, the U.S. FTC issued a request for additional information in connection co's pending acquisition of CTP-656 and other assets from Concert Pharmaceuticals.The second request was issued under notification requirements of the Hart-Scott-Rodino antitrust improvements act.Vertex Pharmaceuticals says it intends to work cooperatively with the FTC as it reviews the transaction.  Full Article

Vertex cystic fibrosis drug gets expanded approval for use in infants

Aug 15 U.S. health regulators have expanded the use of one of Vertex Pharmaceuticals Inc's cystic fibrosis drugs to include patients aged between 12 months and 24 months.