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General Cable Corp. has agreed to pay more than $75 million to resolve U.S. Justice Department and Securities and Exchange Commission charges for violating the Foreign Corrupt Practices Act, the SEC said Thursday. The company will pay the SEC another $6.5 million to settle separate accounting violations. The Kentucky-based maker of copper, aluminum and fiber optic wire and cable products was charged with making improper payments to government officials in Angola, Bangladesh, China, Egypt, Indonesia, and Thailand to get or keep business. “General Cable’s weak internal controls also failed to detect improper inventory accounting at its Brazilian subsidiary, causing the company to materially misstate its financial statements from 2008 to the second quarter of 2012,” said the SEC. The regulator charged Karl Zimmer, General Cable’s then-senior vice president responsible for sales in Angola, with knowingly circumventing internal controls. Shares were down 1% Thursday, but have gained 43% in the year, while the S&P 500 has gained about 10%.

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Endologix Inc. shares rose 8.8% in pre-market trade Thursday after the company said it removed a temporary hold on shipments of some of its medical devices. Shares rose 2.6% in official trade so far. All sizes of the AFX Endovascular AAA System and some sizes of the AFX2 Endovascular AAA System will be shipped out and used in medical procedures “effective immediately,” though testing and improvements on other sizes of the AFX2 system were ongoing, the company said. The hold had been announced on Tuesday. Endologix shares dropped 22.6% week-to-date. Shares have dropped 43.7% year-to-date, compared with a 10.2% rise in the S&P 500 .

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From:: Stock Market News

U.S. stocks were little changed in early trade Thursday, a day after the S&P 500 suffered its biggest one-session drop in months and a triple-digit drop dealt a blow to the Dow Jones Industrial Average’s march toward the 20,000 milestone. The S&P 500 rose 0.1% to 2,252, while the Dow advanced 16 points to 19,850. The Nasdaq Composite was virtually flat at 5,439.

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From:: Stock Market News

Anthera Pharmaceuticals Inc. shares were downgraded to hold from buy by SunTrust Robinson Humphrey on Thursday, after the company said one of its drugs had come up short in a study. Anthera said that the drug Sollpura, which is meant to help a specific kind of maldisgestion in cystic fibrosis patients, “narrowly missed” the primary endpoint for the study. The company said the structure of the study may have hindered the results by not allowing some patients to increase their dosage during the testing, and plans to initiate a new experiment in the first quarter of 2017. The news sent the stock down more than 60% to close Wednesday at 74 cents. “Although we believe Sollpura is an active drug, we see too many clinical and regulatory uncertainties for the program at this moment,” SunTrust analyst Edward Nash wrote in a note. “We are removing all Sollpura revenues from our model and lowering our price target to $1 from $6, which is solely based on cash value.” Shares are down 84% on the year, while the S&P 500 has gained 10%.

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Clinical-stage drug company Cempra Inc. said Thursday it has received a complete response letter from the U.S. Food and Drug Administration regarding its new drug applications (NDAs) for solithromycin, a treatment for community-acquired bacterial pneumonia. The letter says that the FDA cannot approve the NDAs in their current form and says the company must provide additional safety data and resolve unspecified issues with its manufacturing facility. “Based on their review of the NDAs, the CRL stated that the FDA determined the risk of hepatotoxicity had not been adequately characterized,” the company said in a statement. The FDA said the size of the safety database — 920 patients — is too small to measure adverse effects, and is recommending a study of about 9,000 patients. The company said it will seek a meeting with the FDA to discuss the issues raised in the letter. “With more than $225 million of cash on hand, patent protection for solithromycin through 2032 and a pipeline that includes fusidic acid and other potential programs for solithromycin, including an ophthalmic formulation, we have flexibility to determine the best course forward for solithromycin and Cempra,” Chief Executive David Zaccardelli said in the statement. Shares tumbled 28% premarket and are down 80% for the year through Wednesday, while the S&P 500 has gained about 10%.

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From:: Stock Market News