$VRTX (Vertex Pharmaceuticals Incorporated)

$VRTX {{ '2015-11-20T12:40:58+0000' | timeago}} • Announcement

$VRTX said it received permission from EU to market ORKAMBI (lumacaftor/ivacaftor), a newly-developed medicinal product, which will serve patients in the management of cystic fibrosis in ages 12 & older with 2 copies of the F508del mutation. The study is based on a data collected from 24-week global Phase 3 studies, Traffic, Transport & Progress.

$VRTX {{ '2017-07-13T12:31:35+0000' | timeago}} • Announcement

$VRTX announced that the Italian Medicines Agency has agreed to reimburse ORKAMBI (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older who have two copies of the F508del mutation. Effective immediately, hundreds of eligible patients in Italy will have access to this medicine.

$VRTX {{ '2017-06-09T09:55:40+0000' | timeago}} • Announcement

$VRTX shareholders have elected Alan M Garber as an independent member of its board of directors. Garber is provost of Harvard University, the Mallinckrodt Professor of Health Care Policy at Harvard Medical School, a Professor of Economics in the Faculty of Arts and Sciences and a Professor of Public Policy in the Harvard Kennedy School of Govt.

$VRTX {{ '2017-05-18T12:30:41+0000' | timeago}} • Announcement

$VRTX said the U.S. Food and Drug Administration has approved Kalydeco (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator gene. $VRTX lifted outlook for 2017 product revenue of Kalydeco to $740-770MM from $710-730MM.

$VRTX {{ '2017-04-27T21:59:58+0000' | timeago}} • Webcast

In March 2017, $VRTX agreed to acquire CTP-656 (a therapy for the treatment of cystic fibrosis) from Concert Pharmaceuticals in a $160MM deal. The company is in the review period now and it has withdrawn and refiled pre-merger notification with the U.S. regulatory authorities.

$VRTX {{ '2017-04-27T21:35:40+0000' | timeago}} • Webcast

For 2017, $VRTX said that there is an uncertainty, mainly related to the timing of reimbursements in Europe. In France, there is an uncertainty because of the election. However, France is the largest contributor outside the U.S. for the company's 2017 revenues.

$VRTX {{ '2017-04-27T21:16:31+0000' | timeago}} • Webcast

$VRTX said that it is evaluating four next-generation correctors (VX-152, VX-440, VX-659 and VX-445), which will help in treating cystic fibrosis. The company expects to have data from the studies for the first three in 1H17 and from the fourth one in early 2018.

$VRTX {{ '2017-04-27T20:35:56+0000' | timeago}} • Announcement

$VRTX reiterated its FY17 guidance for ORKAMBI revenues and increased the guidance for KALYDECO. The company expects ORKAMBI FY17 total product revenues to be about $1.1-1.3Bil and increased FY17 product revenue guidance for KALYDECO to $710-730MM, from $690-710MM.

$VRTX {{ '2017-04-27T20:32:19+0000' | timeago}} • Announcement

Pharma company $VRTX reported 1Q17 net income of $247.8MM, or $0.99 per share, compared to net loss of $41.6MM, or $0.17 per share during 1Q16. On non-GAAP basis, $VRTX earned $0.41 per share. Revenue increased 79.5% to $714.7MM, helped by increased net product revenues from ORKAMBI.

$VRTX {{ '2017-03-29T11:23:47+0000' | timeago}} • Announcement

$VRTX posted that Tezacaftor/Ivacaftor combination treatment met primary endpoints in two phase 3 studies, regarding the treatment of people with cystic fibrosis. Vertex plans to submit a new drug application to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 3Q17.

$SNH {{ '2017-03-27T14:26:05+0000' | timeago}} • Announcement

The property included in the new JV with a sovereign institutional investor was acquired by $SNH in May 2014 for $1.125Bil. The two buildings are 95% leased to $VRTX through 2028. SNH expects to use cash proceeds from this transaction to repay a portion of the amounts outstanding under its revolving credit facility.

$VRTX {{ '2017-03-06T14:33:44+0000' | timeago}} • Announcement

$VRTX announced it signed a definitive asset purchase agreement to acquire CTP-656, including all worldwide development and commercialization rights, from $CNCE for $160MM in cash. Concert was initially developing CTP-656 as a potential treatment for cystic fibrosis.

$VRTX {{ '2017-01-25T21:43:59+0000' | timeago}} • Announcement

$VRTX expects 2017 product revenue for ORKAMBI to be in the range of $1.1-1.3Bil and for KALYDECO to be in the range of $690-710MM.

$VRTX {{ '2017-01-25T21:43:43+0000' | timeago}} • Announcement

For 4Q16, $VRTX reported a 13.5% YoverY revenue growth in its CF product, helped by the 26% revenue increase from ORKAMBI. Net product revenue from KALYDECO fell 2% in the quarter.

$VRTX {{ '2017-01-25T21:32:00+0000' | timeago}} • Announcement

Pharma company $VRTX reported 4Q16 net income of $32.9MM, or $0.13 per diluted share, compared to net loss of $73.7MM, or $0.30 per diluted share, in the prior year quarter. On a non-GAAP basis, the company earned $0.35 per diluted share, an increase of 94% YoverY. Revenue rose 9.7% to $458.7MM for the quarter.

$VRTX {{ '2017-01-11T17:04:24+0000' | timeago}} • Announcement

$VRTX entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the development and commercialization of four R&D programs. Merck KGaA, Darmstadt, Germany will license two clinical-stage programs, along with two pre-clinical programs. $VRTX will receive an upfront payment of $230MM with royalties on future sales.

$VRTX {{ '2017-01-10T12:29:28+0000' | timeago}} • Announcement

$VRTX expects 2017 global Kalydeco net product revenue of $690-710MM, and Orkambi net product revenue of $1.1-1.3Bil. $VRTX sees combined non-GAAP R&D and SG&A expenses in 2017 of $1.25-1.30Bil. FOr 1Q17, the company expects Orkambi net product revenue to be similar to 4Q16 Orkambi product revenue.

$VRTX {{ '2017-01-10T12:26:27+0000' | timeago}} • Announcement

$VRTX expects to report combined GAAP R&D and SG&A expenses of about $1.48Bil and non-GAAP R&D and SG&A expenses of about $1.21Bil for FY16. The company entered 2017 with about $1.43Bil in cash, cash equivalents and marketable securities. As of Dec. 31, 2016, $VRTX had $300MM outstanding from a credit agreement.

$VRTX {{ '2016-12-19T12:27:14+0000' | timeago}} • Announcement

$VRTX said it reached a pricing and reimbursement agreement for ORKAMBI (lumacaftor/ivacaftor) with the German Federal Association of the Statutory Health Insurances (GKV-SV). ORKAMBI is the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older who have 2 copies of the F508del mutation.

$VRTX {{ '2016-10-25T21:17:00+0000' | timeago}} • Webcast

$VRTX stated that pricing and reimbursement approvals for patients eligible for cystic fibrosis treating drug Orkambi outside of the US are expected to drive significant revenue growth in 2017. The company expects the Orkambi launch to drive revenue growth in 4Q16 and 2017.

$VRTX {{ '2016-10-25T21:09:37+0000' | timeago}} • Webcast

For 2016, $VRTX reiterated the lowered revenue outlook for cystic fibrosis treating drug Orkambi, hurt by U.S. treatment trends and ongoing slower-than-expected launch in Germany. The company will not be able to recognize the revenue for patients in France until it achieves a formal reimbursement agreement.

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