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March 10, 2014
Emerging Biotech Conference 2014 is being held in Snowbird, Utah on March 10-12.
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July 2, 2015
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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July 1, 2015
09:23 EDTEXELExelixis files automatic mixed securities shelf
08:46 EDTEXELExelixis says FDA extends PDUFA action date for cobimetinib NDA
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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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05:51 EDTEXELStocks with implied volatility movement; XOMA EXEL
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June 26, 2015
08:23 EDTAGIOAgios Pharmaceuticals management to meet with JPMorgan
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June 25, 2015
07:41 EDTEPZMEpizyme management to meet with Leerink
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June 24, 2015
09:14 EDTAGIOAgios Pharmaceuticals management to meet with Leerink
Meeting to be held in Boston on June 29 hosted by Leerink.
07:32 EDTAGIOAgios Pharmaceuticals announces first patient dosed with AG-881 in Phase 1 study
Agios Pharmaceuticals announced dose administration for the first patient in a Phase 1, open-label, dose-escalation and expansion study of single agent AG-881, a small molecule that has shown in preclinical studies to fully penetrate the blood-brain barrier and inhibit isocitrate dehydrogenase-1 and IDH2 mutations in cancer models. The purpose of the Phase 1 multi-center, open-label study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced solid tumors. AG-881 will be administered continuously as a single agent dosed orally in a 28-day cycle. The first portion of the study includes a dose-escalation phase in which cohorts of patients will receive ascending oral doses of AG-881 to determine the maximum tolerated dose and/or the recommended Phase 2 dose based on safety and tolerability. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability and clinical activity of the recommended Phase 2 dose.
June 23, 2015
16:18 EDTALNYAlnylam weakness a buying opportunity, says Deutsche Bank
Deutsche Bank said Alnylam's Phase 1 AT-3 conference presentation update was positive, as expected, supporting safety and efficacy. The firm's analyst said weakness could be due to fast money selling and recommends buying shares on weakness.
14:31 EDTALNYAlnylam reports new positive clinical data for ALN-AT3
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