Celgene shares drop 1% on news that FDA has placed six trials on partial or full clinical hold

Celgene Corp. shares dropped 1% in premarket trade Thursday after the company said that the Food and Drug Administration has placed a partial clinical hold on five clinical trials and a full clinical hold on one trial. All of the trials involved are testing the anti-PD-L1 antibody durvalumab, which is part of a class of cancer drugs called checkpoint inhibitors. The FDA’s decision was due to risks seen in other trials for another checkpoint inhibitor, Merck & Co.’s anti-PD-1 antibody pembrolizumab, in combination with immunomodulatory agents. For the trials on partial clinical holds, patients who are benefiting from treatment can stay on the therapy. In the trial with a full clinical hold — which is testing a durvalumab combination in multiple myeloma — patients will be discontinued from treatment; no new patients will be enrolled in any of the six trials, which are in multiple myeloma, lymphoma or chronic lymphocytic leukemia and large B cell lymphoma. Two mid-stage trials with durvalumab, one in myelodysplastic syndromes or in elderly acute myeloid Leukemia and the other in myelodysplastic syndromes, will continue to enroll, Celgene said. Celgene has been developing and commercializing durvalumab for hematologic malignancies with AstraZeneca since 2015. AstraZeneca shares rose 1.3% in premarket trade. Celgene shares have risen 19.2% over the last three months, compared with a 1.3% rise in the S&P 500 .

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European Central Bank leaves interest rates unchanged; investors await Draghi

The European Central Bank on Thursday, as expected, left interest rates unchanged, leaving the focus on ECB President Mario Draghi’s news conference. The ECB Governing Council left the rate on the bank’s main refinancing operations at 0%, while the rate on deposits left overnight at the ECB was maintained at minus 0.4% and the rate on the marginal lending facility was left at 0.25%. The ECB repeated that it expects rates to remain at present levels for an “extended period.” The ECB also reiterated its plan to buy 60 billion euros a month worth of bonds through the end of December and that if the outlook deteriorated, it could increase the size of the program. The key question for traders, however, remains the fate of the bond-buying program beyond the end of the year, with the ECB expected to begin tapering its stimulus program in 2018. Draghi, whose news conference begins at 2:30 p.m. Frankfurt time, or 8:30 a.m. Eastern, is expected to keep plans under wraps due to worries that being explicit about taper plans could spur more unwanted strength in the euro.

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Alnylam Pharmaceuticals’ stock plunges after ‘fatal’ event in hemophilia drug program

Shares of Alnylam Pharmaceuticals Inc. plunged 13% in premarket trade Thursday, after the RNAi therapeutics company said it has suspended fitusiran dosing after a “fatal thrombotic event.” The patient had hemophilia A without inhibitors in a phase 2 open-label extension study of fitusiran. The company said considering fitusiran’s “benefit-risk” profile, it aims to resume dosing as soon as possible after consulting with regulatory authorities. Regarding givosiran for the treatment of acute hepatic porphyrias, Alnylam said it has reached alignment with the Food and Drug Administration on a phase 3 study design. Alnylam’s stock had more than doubled year to date through Wednesday, while the S&P 500 had gained 10%.

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Bristol-Myers Squibb says late-stage cancer drug combination study met endpoints and will be stopped early

Bristol-Myers Squibb Co. said early Thursday that a late-stage clinical trial for cancer drugs Opdivo and Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma showed better overall survival compared to chemotherapy in intermediate and poor risk patients. Overall survival was a co-primary endpoint of the trial; the cancer drug combination also showed to have improved overall survival compared with chemotherapy in all randomized patients, a secondary endpoint. The company said that an independent Data Monitoring Committee has recommended the trial be stopped early, based on a scheduled interim analysis. Renal cell carcinoma is the most common kidney cancer in adults, and the five-year survival rate for patients with metastatic or advanced kidney cancer is 12.1% globally, the company said. Bristol-Myers shares lifted 0.13% in premarket trade Thursday. Company shares have surged 13.9% over the last three months, compared with a 1.3% rise in the S&P 500 .

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Procter & Gamble fires latest salvo in battle with activist investor Nelson Peltz

Consumer goods giant Procter & Gamble fired the latest salvo in its battle with activist shareholder Nelson Petlz Thursday, dismissing a 94-page white paper prepared by Peltz as containing “nothing substantive”. The company said it has held numerous talks with Peltz since he amassed a stake in the company, but that he has a “very outdated and misinformed” view of the company. “P&G is confident it has the right plan, the right structure and the right Board in place to continue its successful transformation and deliver results and shareholder value for the short-, mid- and long term,” said the company, reiterating the stance it has taken with Peltz from the outset. The company was already on the right track before he made his investment, it said, and is a “profoundly” different company today than it was a few years ago. P&G shares were not yet active premarket, but have gained 10% in 2017, matching the performance of the Dow Jones Industrial Average and the S&P 500 .

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Del Potro defeats Federer to reach U.S. Open semi-finals

Juan Martin del Potro has beaten Roger Federer to move through to the semi-finals of the U.S. Open tennis competition. The 24th seed sealed his upset victory against the Swiss player on Wednesday in four sets, according to media reports. The 28-year-old Argentinian now goes on to meet top seed Rafael Nadal, who defeated Russian teenager Andrey Rublev in his own quarter-final in New York. The other semi-final at Flushing Meadows will be a contest between Spain’s Pablo Carreno Busta and South Africa’s Kevin Anderson. On the women’s side, all four semi-finalists at the U.S. Open are Americans. At stake for both men and women is a first prize of $3.7 million, while semi-finalists will each receive $920,000.

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Deere to acquire Blue River Technology for $305 million

Deere & Co. said late Wednesday it’s acquiring Blue River Technology to increase the machine-learning capabilities of farm equipment. Deere said it is paying $305 million to acquire the Sunnyvale, Calif.-based company, which uses computer imaging and machine learning for agricultural spraying and weeding equipment. Deere expects to close the acquisition in September. Shares of Deere were unchanged after hours at $116.22.

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Trump unlikely to nominate Cohn as Fed chair: WSJ

President Donald Trump is unlikely to nominate his economic adviser Gary Cohn to become Federal Reserve chairman, the Wall Street Journal reported Wednesday. The report said that Cohn’s chances dropped after he criticized the president’s response to the Charlottesville alt-right protests, the report said, quoting people familiar with the president’s thinking. Trump had earlier said that Cohn was in the running for the job.

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Facebook links thousands of political ads to Russian troll farm

Facebook Inc. said Wednesday that it traced ad sales totaling $100,000 from Russian accounts, some of which are likely linked to a troll farm in St. Petersburg called the Internet Research Agency. The roughly 3,000 ads from 470 accounts ran between June of 2015 and May of 2017 and focused on political issues such as gun rights, immigration, LGBTQ issues and racial discrimination. According to the Washington Post, some of the ads specifically name checked Republican Donald Trump and Democrat Hillary Clinton. The company’s blog also said it conducted a broad search for ads that found an additional $50,000 tied to 2,200 ads that “might have originated in Russia” and had “very weak signals of a connection … not associated with any organized effort.” During and after the 2016, election Facebook was subject to criticism that it spread false information, though chief executive Mark Zuckerberg has said that only a “very small amount” is fake or hoaxes. During the regular session Wednesday, the company’s shares edged up nearly 1% to $172.09, nearly touching its record closing high of $172.45 set July 28. The stock has gained 49.6% this year, with the S&P 500 index gaining 10.1%.

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API data show rise in U.S. crude supply, but gasoline stockpiles fall: sources

The American Petroleum Institute reported Wednesday that U.S. crude supplies rose 2.8 million barrels for the week ended Sept. 1, but gasoline stockpiles fell by 2.5 million barrels, according to sources. The API data, which were delayed by a day because of the Labor Day holiday, also showed that inventories of distillates edged down by 603,000 barrels, sources said. Supply data from the Energy Information Administration will be released Thursday morning. Analysts polled by S&P Global Platts expect the EIA to report a climb of 2.7 million barrels in crude inventories, along with declines of 4.2 million barrels for gasoline and 1.9 million barrels for distillate supplies. October crude was at $49.16 a barrel in electronic trading, unchanged from the settlement on the New York Mercantile Exchange.

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