Tag: stock market

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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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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Fortress Biotech Inc. gained as much as 75% in late trading Wednesday after the company detailed a success story for an approach to cancer that has suffered of late. Fortress said a 50-year-old man suffering from a recurrent and particularly deadly form of brain cancer was treated with a drug developed from his own genetically modified T cells in an early clinical trial of the approach, developed by Fortress’s Mustang Bio Inc. unit. The man, who had not responded to previous standard treatments, achieved complete remission and “returned to normal life and work activities,” Fortress Bio said in Wednesday’s news release. The drug, referred to as MB-101, is a form of CAR-T immunotherapy, which uses the patient’s own immunities to fight cancer cells; the approach has generated a lot of buzz, but has been damaged by the deaths of patients in a study by Juno Therapeutics Inc. earlier this year. “This clinical experience provides remarkable evidence of the potential of CAR T cell immunotherapy to improve the treatment of patients with aggressive brain tumors,” said Dr. Christine Brown, lead author of the case study, which will be published in the Dec. 29 edition of the New England Journal of Medicine. Fortress stock moved as high as $4 in late trading after closing at $2.29.

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The American Petroleum Institute on Wednesday reported that U.S. crude oil inventories rose 4.2 million barrels in the latest week, news reports said. Official inventory data from the Energy Information Administration is due Thursday morning. Analysts surveyed by The Wall Street Journal expect that report to show a 1.4 million barrel decline in crude supplies.

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Software company AppDynamics filed for an initial public offering Wednesday, after delaying it earlier this year. The company had previously said it was delaying its offering until 2017 due to uncertainty after the U.S. presidential election, according to the Wall Street Journal. The company filed for an offering of up to $100 million. The company is valued by private investors at $1.9 billion. AppDynamics applied to list on the Nasdaq Global Select under the symbol “AAPD.” The lead underwriters on the offering are Morgan Stanley, Goldman, Sachs & Co. and J.P. Morgan.

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Stocks gave up early gains, ending broadly lower and near session lows Wednesday with losses led by the tech sector. The Dow industrials came within 20 points of the psychologically important 20,000 milestone in early trade but soon lost steam. The blue-chip gauge ended the day down 111.36 points, or 0.6%, to end at 19,833.68, according to preliminary figures. The S&P 500 declined 0.8% to 2,249.92. The Nasdaq Composite lost 48.89 points, or 0.9%, to settle at 5,438.56 a day after closing at a record.

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Gold futures rose for a third straight session to settle at two-week highs Wednesday. The February contract was up up $2.00, or 0.2%, to $1,141 an ounce. Gold is attempting to snap a streak of seven weekly declines. The ICE Dollar Index , which typically moves inversely to gold but broke from that relationship Wednesday, was up 0.4% at 103.43.

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Shares of Kate Spade & Co. surged 17% in early afternoon trade, after the Wall Street Journal said the retailer is working with an investment bank to explore a sale of the company, citing people familiar with the matter. The company has come under pressure from activist hedge fund Caerus Investors, which in November, disclosed a stake. Shares are down 4.8% in the year so far, while the S&P 500 has gained about 11%.

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Stocks posted small gains in early action Wednesday, with the Nasdaq building on the previous session’s record close and the Dow Jones Industrial Average set to take yet another run at the 20,000 milestone. The Dow rose 27 points, or 0.1%, to 19,927, while the S&P 500 advanced 0.1% to 2,271. The Nasdaq tacked on 0.2% to 5,497.

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