Cigna Corp.’s acquisition byhealth-insurance rival Anthem Inc. may not be approved this year,Cigna said Friday in a regulatory filing.

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Shares of both companies declined. An analyst said the delaycould be a sign of trouble for the deal, which is one of twopending health-insurance combinations being scrutinized byregulators who have expressed concern about further concentrationof the health-care industry.

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Read: Cigna, Humana boost profuits, take hits inindividual market

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“While the company continues to work toward achieving regulatoryapproval as quickly as possible and to target a closing date in thesecond half of 2016, the closing will ultimately be subject to theapproval and timing of the regulators,” Cigna said in its quarterlyreport with the U.S. Securities and Exchange Commission. “In lightof the complexity of the regulatory process and the dynamicenvironment, it is possible that such approvals may not be obtainedin 2016.”

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Joe Swedish, Anthem’s chief executive officer, said last weekthat he expected the acquisition of Cigna to be completed in thesecond half of this year. On Friday, Jill Becher, an Anthemspokeswoman, said the insurer continued to expect the transactionto be completed on that timeline.

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Anthem agreed in July to buy Cigna in a cash-and-stock deal thatvalued Cigna at about $48 billion. The transaction, along withAetna Inc.’s pending acquisition of Humana Inc., would reduce thenumber of big U.S. health insurers to three from five.

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Read: Anthem gains under Obamacare, tops earningsestimate

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The Anthem-Cigna merger requires approval from the JusticeDepartment’s antitrust division as well as state insuranceregulators. In March, Bill Baer, now the No. 3 official at theJustice Department, called the Cigna deal and Aetna’s deal forHumana “transformational” and said they required close scrutinyfrom the government.

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Matt Asensio, a Cigna spokesman, declined to specify why theinsurer cautioned that the deal may not happen this year.

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“This disclosure reflects our current understanding, based onthe breadth and depth of the review and where we believe we are inthe process now,” Asensio said. “We feel that it’s a dynamicenvironment, and there’s a lot of complexity in the regulatoryprocess, so it’s possible that the approvals may not be obtained in2016.”

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Cigna said in the filing that Anthem may owe it a breakup fee of$1.85 billion if the transaction isn’t completed by Jan. 31, 2017.That deadline can be pushed back to April 30, Cigna said.

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Cigna fell 1.9 percent to $132.40 at 10:30 a.m. in New York,while Anthem declined less than 1 percent to $136.77.

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Peter Costa, an analyst at Wells Fargo & Co., said Cigna’sdisclosure indicates the deal could be delayed or not approved atall. “The 10Q deal timing disclosure is a significant item thatlikely widens the spread,” he wrote in a research note toclients.

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