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Stock Market & Financial Investment News

News For CAT;IQNT;GRMN;JCP;JNJ;KRC;NKTR;STRA;VRTX;VNO;BMY;PBR;HES 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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16:04 EDTPBROptions Update; July 2, 2015
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15:19 EDTPBRVantage challenges allegations of ties to arrest of former Petrobras director
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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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11:14 EDTPBRStocks with call strike movement; CHK PBR
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05:50 EDTPBRStocks with implied volatility movement; PBR YELP
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July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
16:00 EDTPBROptions Update; July 1, 2015
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June 30, 2015
15:20 EDTJCPMoody's raises J.C. Penney liquidity rating to SGL-1 from SGL-2
Moody's Investors Service revised J.C. Penney's rating outlook to positive from stable. Moody's also affirmed the company's Caa1 Corporate Family Rating, and raised the company's Speculative Grade Liquidity rating to SGL-1 from SGL-2. "The rating outlook revision to positive from stable reflects Moody's view that JC Penney's operating performance has shown signs of improvement as a result of better merchandising, cost controls, and integration of its online business" said Moody's Vice President Scott Tuhy. He added, "we have seen positive momentum building for the company to achieve $700M to $800M of adjusted EBITDA, a level in which earnings would fully cover cash flow and interest". The upgrade in the Speculative Grade Liquidity rating primarily reflects the company's improved operating performance as we expect free cash flow to be near break-even levels and the company's meaningful cash balances are sufficient to cover expected seasonal working capital needs.
10:00 EDTPBROn The Fly: Analyst Upgrade Summary
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09:05 EDTKRCKilroy Realty raises $250M in a direct equity placement
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07:32 EDTVRTXVertex should get Orkambi approval by Monday or sooner, says Piper Jaffray
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