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News Breaks
March 18, 2013
09:11 EDTNUVANuVasive says received FDA warning letter related to San Diego facility
On March 13, NuVasive received a warning letter dated March 12 from the FDA related to an inspection of the company’s San Diego, California facility that occurred from October 29, 2012 through November 2, 2012. The inspection did not result in any 483 observations and the warning letter does not cite any quality system concerns.The FDA letter identifies specific labeling claims related to the company’s ILIF procedure, indicating that one of the indications noted is not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The letter only relates to this promotional claim and the company does not anticipate a disruption in the distribution of these products. The company takes this matter seriously and has already begun to respond to the FDA’s requests. The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations. Comments taken from an 8-K filing.
News For NUVA From The Last 14 Days
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July 30, 2015
15:52 EDTNUVANuVasive to pay $13.5M to settle false claims allegations
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July 29, 2015
10:00 EDTNUVAOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: 3D Systems (DDD) upgraded to Neutral from Underperform at Longbow... AK Steel (AKS) upgraded to Outperform from Neutral at Macquarie... Ally Financial (ALLY) upgraded to Outperform from Neutral at Credit Suisse... Amazon.com (AMZN) upgraded to Buy from Hold at Stifel... Arrow Electronics (ARW) upgraded to Buy from Underperform at CLSA... Beacon Roofing (BECN) upgraded to Buy from Neutral at CL King... Citrix (CTXS) upgraded to Outperform at Baird... Commvault (CVLT) upgraded to Buy from Hold at Jefferies... FireEye (FEYE) upgraded on positive checks, business mdoel changes at Oppenheimer... Hibbett Sports (HIBB) upgraded to Neutral from Underperform at Sterne Agee CRT... Integra LifeSciences (IART) upgraded to Outperform at Raymond James... M/A-COM (MTSI) upgraded to Buy from Hold at Needham... Norsk Hydro (NHYDY) upgraded to Neutral from Underperform at Exane BNP Paribas... NuVasive (NUVA) upgraded to Outperform from Market Perform at Northland... SM Energy (SM) upgraded to Outperform from Market Perform at Raymond James... Scorpio Bulkers (SALT) upgraded to Buy from Hold at Deutsche Bank... Sirius XM (SIRI) upgraded to Buy from Hold at Wunderlich... Sprouts Farmers Markets (SFM) upgraded to Neutral from Underperform at Longbow... Supervalu (SVU) upgraded to Equal Weight from Underweight at Morgan Stanley... Waters (WAT) upgraded to Outperform from Market Perform at Wells Fargo... Wells Fargo (WFC) upgraded to Buy from Neutral at Guggenheim... Williams-Sonoma (WSM) upgraded to Overweight from Neutral at JPMorgan... YRC Worldwide (YRCW) upgraded to Strong Buy at Raymond James.
09:20 EDTNUVANuVasive upgraded to Outperform, expects strong 2H at Northland
As previously reported, Northland upgraded NuVasive to Outperform from Market Perform and raised its price target to $68 from $48. The firm expects 2H results to beat expectations and is a buyer ahead of Q3 results given strength in the U.S. spine market, operating performance, and leverage. Northland views the iGA platform as a "game changer" and checks show NuVasive continues to take market share.
07:44 EDTNUVANuVasive price target raised to $65 from $57 at Leerink
Leerink raised its price target for NuVasive to $65 saying the margin improvement story "has legs" following the company's Q2 results. The firm reiterates an Outperform rating on the stock.
07:22 EDTNUVANuVasive upgraded to Outperform from Market Perform at Northland
July 28, 2015
16:31 EDTNUVANuVasive reaches definitive agreement with U.S. DOJ
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16:20 EDTNUVANuVasive raises 2015 EPS outlook to $1.17 from $1.10, consensus $1.12
Sees 2015 revenue $810M, consensus $812.22M.
16:19 EDTNUVANuVasive reports Q2 EPS 31c, consensus 25c
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16:18 EDTNUVANuVasive enters $13.5M settlement of Justice Department
NuVasive announced that it has reached a definitive settlement with the U.S. Department of Justice related to the subpoena issued to the company by the Office of Inspector General of the Department of Health and Human Services in 2013. NuVasive admits no wrongdoing as part of the settlement. On April 29, the company announced that it had reached an agreement in principle to settle the investigation with the DOJ. The company has now entered into a definitive settlement agreement with the United States, acting through DOJ and on behalf of OIG, the Defense Health Agency, the Office of Personnel Management, and the U.S. Department of Veteran Affairs. Under the terms of the settlement agreement, the company will pay $13.5M, plus fees and accrued interest. The settlement is neither an admission of liability or wrongdoing by the company nor a concession by the United States that its claims are not well founded. The company was not required to enter into a corporate integrity agreement by the OIG as part of the settlement.
15:21 EDTNUVANotable companies reporting after market close
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