Exelix shares surge 19% premarket after FDA grants priority review to kidney cancer drug

Shares of biotech Exelixis Inc. rallied 19% in premarket trade Monday, after the company said it has won U.S. Food and Drug Administration priority review status for its supplemental New Drug Application (sNDA) for a treatment for advanced renal cell carcinoma (RCC). The company said its sNDA is based on results from a mid-stage trial of Cabometyx, and is aimed at patients with previously untreated advanced RCC. If approved, the company will be able to make changes to the product label, including modifications to the indication. Cabometyx was approved by the FDA in April of 2016 for the treatment of patients with advanced RCC who have received prior anti-angioegenic therapy, or drugs that stop tumors from growing their own blood vessels. Kidney cancer is one of the top 10 most common forms of cancer in the U.S., the company said. Exelixis shares have gained 66% in 2017, while the S&P 500 has gained 14%.

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Catalonia must drop independence call by Thursday: Spain’s deputy PM

The Spanish government has given Catalonia’s separatist leader Carles Puigdemont until Thursday morning to drop plans to make the region independent, Spain’s Deputy Prime Minister Soraya Saenz de Santamaria said on Monday. If the Catalan leader sticks to his bid to split from Spain, the central government in Madrid will take control of the region and rule it directly, by triggering the so-called Article 155 of the Spanish constitution. “Mr. Puigdemont still has the opportunity to start resolving this situation, he must answer ‘yes’ or ‘no’ to the declaration,” Saenz de Santamaria said. Spanish Prime Minister Mariano Rajoy had given Puigdemont a deadline of Monday at 10 a.m. local time, or 4 a.m. Eastern Time, to clarify whether he had declared independence for the region in an ambiguous statement made last Tuesday. Puigdemont in a letter before the Monday deadline said the aim is to negotiate over the next two months, but didn’t clarify if he had declared independence or not.

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Catalan leader dodges clear declaration of independence

Catalan leader Carles Puigdemont has responded to the Spanish government’s demand that he clarify whether the region has declared independence without actually clarifying the matter, local media reports said Monday. In a letter, Puigdemont says the aim is to hold a dialogue and negotiate over the next two months. However, it does not add any more information to the ambiguous statement the Catalan president made on Tuesday, in which he seemed to make a declaration of independence and then suspend it immediately. Spanish Prime Minister Mariano Rajoy then demanded the Catalan government say whether it had made an official declaration, with a deadline of Monday, Oct, 16. Puigdemont may face prosecution and a prison sentence if he does make a declaration.

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Chinese peer-to-peer lender Paipaidai files IPO documents

PPDAI Group Inc. hopes to raise $350 million in its initial public offering, according to documents filed with the Securities and Exchange Commission late Friday. The China-based company said it intends to list American depository shares on the New York Stock Exchange under the ticker symbol “PPDF.” It has been rumored to be going public for some time, with The Wall Street Journal reporting it was formulating plans in 2016. The $350 million it hopes to raise is likely a placeholder and per the Journal report was valued at roughly $2 billion in 2016. Known as Paipaidai, the company offers unsecured peer-to-peer loans and said that it had 48 million registered users as of June. In the first six months of 2017, the company logged a net loss of $60 million on sales of $255 million. Credit Suisse, Citigroup and Keefe, Bruyette & Woods are listed as underwriters.

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TransEnterix shares soar on FDA clearance of robotic surgery device

TransEnterix Inc. shares soared in the extended session Friday after the Food and Drug Administration gave marketing clearance to the company’s robotic surgery device. TransEnterix shares jumped 63% to $2.38 on after-hours volume of more than 1 million shares. Late Friday, the FDA announced it had granted marketing clearance to TransEnterix’s Senhance System that gives surgeons a 3-D high-definition view of the surgical field and remote control of three robotic arms to perform procedures.

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VoIP provider Bandwidth files IPO documents

Bandwidth Inc. hopes to raise $85 million in its initial public offering, according to documents filed with the Securities and Exchange Commission late Friday. The Raleigh, N.C.-based company said it intends to list on Nasdaq under the ticker symbol “BAND” and will have two share classes. Bandwidth is a cloud-based communications platform that offers VoIP services, as well as text messaging to enterprise-sized customers. For the first six months of 2017 the company logged a net income of $4.9 million on sales of $79.2 million. The company said it has 865 customers, and includes Microsoft Corp. and Alphabet Inc. . Morgan Stanley, Keybanc Capital Markets and Baird are among the underwriters listed.

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Nasdaq closes out the week at a record, broader market ends slightly higher

U.S. equity benchmarks finished the week on a high note on Friday, amid economic data including weaker-than-expected inflation but strong retail sales numbers. The Dow Jones Industrial Average rose 0.1% to 22,871.72, just shy of an all-time high, and ended 0.4% on the week, making it the fifth rise in a row. The S&P 500 ended 0.1% higher at 2,553.17, registering a 0.2% weekly gain–its fifth a row. The Nasdaq Composite index rose 0.2% to a record close at 6,605.80, and 0.2% on the week for a third weekly gain in a row. In individual stocks, Bank of America and Wells Fargo & Co. reported third-quarter earnings today, with B. of A. registering some gains and Shares of Wells Fargo declined on its weaker-than-expected numbers.

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Dow, S&P 500, Nasdaq close out the week with a fresh round of records

U.S. equity benchmarks finished the week on a high note on Friday, amid economic data including weaker-than-expected inflation but strong retail sales numbers. The Dow Jones Industrial Average rose 0.1% to 22,871, and 0.4% on the week, making it the fifth rise in a row. The S&P 500 closed 0.1% higher at 2,553, registering a 0.2% weekly gain–its fifth a row. The Nasdaq Composite index rose 0.2% to about 6,605, and 0.2% on the week for a third weekly gain in a row. In individual stocks, Bank of America and Wells Fargo & Co. reported third-quarter earnings today, with B. of A. registering some gains and Shares of Wells Fargo declined on its weaker-than-expected numbers.

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PG&E shares down 10% after California wildfire liability warning

Shares of PG&E Corp. fell more than 10% in the late session Friday after the company acknowledged that it may face some liability stemming from the California wildfires. PG&E “has about $800 million in liability insurance for potential losses that may result from these fires. If the amount of insurance is insufficient to cover (PG&E’s) liability or if insurance is otherwise unavailable, PG&E Corporation’s and the Utility’s financial condition or results of operations could be materially affected,” the company said in a filing Friday. Possibly downed power lines are among the causes under investigation for the deadly fires in northern California counties.

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Apple may not be able to ramp iPhone X production until December, analyst says

Apple Inc. may not ramp up production volume on its flagship iPhone X until December, according to a Friday research note from Cascend Securities. Apple shares are up less than 1% to $156.89 in late-session trading. Though iPhone X sales are set to kick off with pre-orders on Oct. 27 and availability Nov. 3, the manufacturing and supply chain partners Apple uses are privately saying that volumes will not be ready in November. Cascend analyst Eric Ross told MarketWatch that normally device manufacturers build up inventory and ensure it’s in the hands of retail outlets and carriers so gadgets are available to consumers on launch day. “But they don’t seem to be doing it this year,” he said. As for the iPhone 8, consumer interest is “OK but not tremendous” and customers are not buying as much as Cascend expected, the note says. While iPhone 8 supply is good, the discounts have not yet been enough give wireless carriers incentives to attract more customers to two-year contracts. Apple stock is up 35% this year, with the S&P 500 index up 13.9%. The Dow Jones Industrial Average , of which Apple is a component, is up 15.8% this year.

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