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March 20, 2014
08:04 EDTSTJSt. Jude Medical announces Prodigy CE Mark approval, European launch
St. Jude Medical announced the CE Mark approval and European launch of its Prodigy Chronic Pain System with Burst Technology. The new device offers patients traditional tonic spinal cord stimulation in addition to Burst Technology for stimulation options.
News For STJ From The Last 14 Days
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October 8, 2015
16:39 EDTSTJSt. Jude Medical completes acquisition of Thoratec
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October 7, 2015
16:29 EDTSTJThoratec shareholders approve acquisition of company by St. Jude Medical
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October 5, 2015
15:15 EDTSTJStudy finds potential stroke risk with prosthetic heart valves
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10:52 EDTSTJAnalysts downplay potential impact of St. Jude FDA warning letter
Shares of St. Jude Medical (STJ), a developer, manufacturer and distributor of cardiovascular medical devices, are slightly higher in morning trading after analysts said that the company's receipt of a U.S. Food and Drug Administration warning letter for its Atlanta facility "doesn't look that bad." WHAT'S NEW: On Friday afternoon, St. Jude Medical disclosed in a regulatory filing that it received a warning letter from the FDA, which related to "observed non-conformities" at its Atlanta facility, where it manufactures the CardioMEMS HF system. St. Jude said that the FDA had from June 8-26 inspected the company's Atlanta facility and that various devices of the company manufactured at its Atlanta plant were found to be "adulterated." The FDA also said certain of the company's manufacturing, packing, storage and installation practices "are not in conformity" to the current goods and manufacturing practice requirements. St. Jude said it would continue to manufacture and ship the product from the Atlanta facility and does not expect customer orders to be impacted. WHAT'S NOTABLE: In January 2013, the FDA sent St. Jude Medical a warning letter detailing concerns regarding processes at the company's Sylmar, California facility; the letter did not raise any safety concerns about St. Jude Medical products. The company later detailed efforts to correct problems found during the inspection at the plant, which makes heart defibrillator leads. ANALYST REACTION: Deutsche Bank analyst Kristen Stewart kept a Hold rating on the stock and said that the warning letter "doesn't seem that bad" because St. Jude does not expect any impact on its ability to fulfill or ship customer orders and does not expect a material financial impact relating to the matter. Stewart noted that the FDA "seems satisfied" with the remediation made and has not expressed concerns about the need for a product recall or stop shipment. Similarly, Piper Jaffray analyst Brooks West believes the warning letter will not have a commercial impact on the company, and that the cost of alleviating the FDA's observations "are limited." West has an Overweight rating and $84 price target on the stock. PRICE ACTION: St. Jude Medical is up 0.2% to $63.94 in morning trading. ANOTHER TO WATCH: Thoratec (THOR), which agreed in late July to be acquired by St. Jude Medical, is essentially flat at $63.45.
06:21 EDTSTJSt. Jude Medical warning letter doesn't look that bad, says Deutsche Bank
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October 2, 2015
17:33 EDTSTJSt. Jude Medical receives FDA warning letter specific to Atlanta facility
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September 30, 2015
18:07 EDTSTJS&P announces changes to the S&P 400, 500 indices
S&P 500 constituent Joy Global (JOY) will replace Thoratec (THOR) in the S&P MidCap 400, and Verisk Analytics (VRSK) will replace Joy Global in the S&P 500 after the close of trading on Wednesday, October 7. S&P 500 constituent St. Jude Medical (STJ) is acquiring Thoratec in a deal expected to be completed on or about that date, pending final approvals. Joy Global has a market capitalization more representative of the mid-cap market space.
September 27, 2015
17:29 EDTSTJThoratec reports HeartMate 3 CE Mark trial met primary endpoint
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