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Date Title and Summary Additional Formats
Toggle Summary Vertex Sells INCIVO ® Product Royalty Rights for $152 Million
-Vertex to receive $152 million cash payment from Janssen in 2013; will no longer receive royalties on INCIVO sales beginning in 2014- -Company increases 2013 year-end guidance for cash, cash equivalents and marketable securities to in excess of $1.4 billion - CAMBRIDGE, Mass.
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Toggle Summary Vertex Shareholders Approve Proxy Proposals at Annual Meeting
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2011 Annual Meeting of Shareholders. At the meeting, shareholders re-elected director nominees Matthew W. Emmens and Wayne J. Riley , M.D.
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Toggle Summary Vertex Starts Global Phase 3b Study to Evaluate the Potential for People with Hepatitis C to Achieve a Viral Cure (SVR) with a Total Treatment Duration of 12 Weeks of INCIVEK™ Combination Therapy
— CONCISE study will evaluate twice-daily INCIVEK in combination with pegylated-interferon and ribavirin among patients new to treatment and prior relapsers who have the ‘CC' variation near the IL28B gene — CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary Vertex Submits Application for Priority Review and Approval of KALYDECO™ (VX-770, ivacaftor) in the U.S. as First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
-- Accelerated assessment of KALYDECO granted by the European Medicines Agency ; MAA submission planned in EU by the end of October -- -- Phase 3 registration studies of KALYDECO showed significant improvements in lung function and other measures of disease among a subset of people with CF --
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Toggle Summary Vertex Submits Applications in the U.S. and Europe for Approval of Lumacaftor in Combination with Ivacaftor for People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
-U.S. submission includes request for Priority Review; Accelerated Assessment has been granted in the EU- -Approximately 8,500 people in the U.S. and 12,000 in Europe ages 12 and older have two copies of the F508del mutation- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
-Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations- BOSTON --(BUSINESS WIRE)--Jul. 22, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for KALYDECO™ (ivacaftor) Monotherapy for People with Non-G551D Gating Mutations
-sNDA also includes long-term safety and efficacy data for KALYDECO from PERSIST open-label rollover study- -Marketing Authorization Application (MAA) variation in Europe planned for October 2013 - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today
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Toggle Summary Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for Use of KALYDECO® (ivacaftor) in People 18 and Older with Cystic Fibrosis who have the R117H Mutation
-Marketing Authorization Application (MAA) variation in Europe planned for third quarter of 2014- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S.
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Toggle Summary Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program
-Plasma HCV RNA levels are less than 10 IU/mL in 12 of 12 patients after 28 days of dosing with VX-950/peg-IFN/RBV in Phase II study-
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Toggle Summary Vertex to Acquire CTP-656 from Concert Pharmaceuticals for the Treatment of Cystic Fibrosis
-Vertex to develop CTP-656 for potential use in future combination regimens aimed at treating the underlying cause of CF- -Concert to receive $160 million in cash with potential for $90 million in future regulatory approval milestone payments- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
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