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Stock Market & Financial Investment News

News Breaks
July 31, 2014
16:42 EDTVRTXVertex receives European approval for KALYDECO in eight gating mutations
Vertex Pharmaceuticals announced that the European Commission has approved KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. KALYDECO was first approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which is the most common gating mutation. The eight additional gating mutations included in today’s approval are G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250 people ages 6 and older have one of these non-G551D gating mutations.
News For VRTX From The Last 14 Days
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July 2, 2015
16:28 EDTVRTXOn The Fly: Top stock stories for Thursday
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14:51 EDTVRTXVertex expects payers to provide 'broad access' for Orkambi
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14:50 EDTVRTXVertex to resume trading at 3:00 PM ET
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14:42 EDTVRTXVertex says 'too early to comment' on international Orkambi pricing
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14:33 EDTVRTXVertex sets Orkambi price at $259,000, sees delivery to pharmacies 'within days'
Following today's confirmation from Vertex that Orkambi has received FDA approval, the company held a conference call providing an update on the drug. Vertex remarked that it is "ready to launch this medicine." Vertex will offer a co-pay assistance program for the drug, with certain eligibility criteria. Company believes it can achieve a similar patient cost situation as Kalydeco. Sets price of Orkambi at $259,000 per year. Expects delivery to pharmacy network "within days."
13:52 EDTVRTXVertex to hold a conference call
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13:47 EDTVRTXVertex confirms FDA approval of ORKAMBI
Vertex Pharmaceuticals announced that the U.S. FDA approved ORKAMBI, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test. People with two copies of the F508del mutation represent the largest group of people with CF. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two copies of the F508del mutation. ORKAMBI will be available for shipment to specialty pharmacies in the United States within days.
12:47 EDTVRTXVertex to return to profitability with approval, says Piper Jaffray
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12:00 EDTVRTXVertex receives FDA approval for Orkambi
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11:50 EDTVRTXVertex trading halted, pending news
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June 30, 2015
07:32 EDTVRTXVertex should get Orkambi approval by Monday or sooner, says Piper Jaffray
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June 29, 2015
15:28 EDTVRTXVertex management to meet with UBS
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07:47 EDTVRTXCerulean appoints Stuart A. Arbuckle to board of directors, effective June 26
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