>>> Gilead Sciences Inc To Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early Because of Positive Risk-Benefit

Gilead Sciences Inc To Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early Because of Positive Risk-Benefit - DMC recommendation is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone. The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated CLL. Gilead has informed the U.S. Food and Drug Administration (FDA) of the plan to end the study and will engage in a dialogue with the FDA regarding a regulatory filing in CLL. Data from Study 116 will be submitted for presentation at an upcoming scientific conference. - Chief Scientific Officer: This is the first Phase 3 study to report positive results for a new class of targeted therapies that inhibit B-cell receptor signaling as a major component of their mechanism of action, an important area of focus in the development of chemotherapy-free regimens in CLL and other B-cell malignancies. - A new drug application (NDA) for idelalisib was submitted for refractory indolent non-Hodgkins lymphoma (iNHL) on September 11, 2013. Gilead plans to file for regulatory approval of idelalisib in the European Union later this year.

>>> BlackBerry Canada pension fund indicates it could join a consortium and bid for the company

BlackBerry Canada pension fund indicates it could join a consortium and bid for the company - financial press

**NOTE: 10/04 20:29:13 BBRY: Google, Cisco, SAP, Intel and others considering bids for all or part of Blackberry; still unclear which if any will make bids that would offer alternative to the Fairfax tentative offer of $9/shr. Korean tech giants Samsung and LG are also said to be potential bidders. BBRY has asked for preliminary expressions of interest from potential buyers by early next week. The firms are said to be most interested in Blackberry's secure server network and its patent portfolio. - 9/23: Holder Fairfax (10% stake) enters letter of intent offering $9/shr for BBRY subject to due diligence. - 10/02: Reportedly Blackberry has attracted interest from a few PE firms; Co-founder Lazaridis (5.7% stake) is still interested in putting together an offer for the company.

WSJ : Activist Pushes for Split of Darden Restaurants

Activist Pushes for Split of Darden Restaurants Barington Capital Wants to Separate Red Lobster, Olive Garden From Rest of Company

An activist investor is hungry for change at Darden Restaurants Inc. DRI +5.73%

Hedge fund Barington Capital Group LP has taken a 2.8% stake in Darden, the owner of Olive Garden, Red Lobster and six other restaurant chains. The fund is pushing for Darden to form two separate companies, among other changes, according to people familiar with the matter.

New York-based Barington, which has amassed its Darden stake together with other investors, has held talks with the restaurant operator's management. The investors argue that Darden should create one company with its Olive Garden and Red Lobster restaurants, and another with its higher-growth chains, which include Capital Grille, the people said.

It isn't clear what other investors are in the group, which also has urged the company to reduce costs faster than it already is and to try to cash in on its real estate. Based on Darden's current market value of about $6.05 billion, the group's stake is worth nearly $170 million. "We believe that Darden has the potential to deliver significantly higher returns to shareholders," said a Barington spokesman.

A spokesman for Darden said the company "welcomes input on enhancing shareholder value," adding that its board "will take the time necessary to thoroughly evaluate Barington's suggestions, just as the company does for any of its shareholders."

Based in Orlando, Fla., Darden has more than 2,100 restaurants in North America, which, in addition to the other chains include the LongHorn Steakhouse, Yard House, Eddie V's Prime Seafood, Seasons 52 and Bahama Breeze brands. The company owns the land at more than 1,000 of its restaurants, according to financial filings.

Darden has been hurt by economic weakness as some consumers shift to lower-priced fast-food restaurants, while others gravitate toward chains like Chipotle Mexican GrillCMG +0.49% and Potbelly PBPB +1.99% that don't have table service and therefore offer the prospect of quicker meals—and no tips.

At Olive Garden—Darden's biggest chain by revenue—same-restaurant sales dropped 4% in the first fiscal quarter, while they fell 5.2% at Red Lobster.

The company also has been hit with higher food and labor costs. During its most recent earnings call, Darden said that it would aim to save about $50 million annually.

Reflecting the challenges the company faces, its stock price had fallen about 15% over the past 12 months. It was little changed at $46.35 around midday Wednesday before surging more than 6% on The Wall Street Journal's report of the Barington group's stake.

In its most recent quarter, Darden's overall sales grew 6.1% to $2.16 billion, and the company posted a $70.2 million profit. Sales at its other chains have been more robust as well-off consumers continue dining at upscale restaurants. Same-store sales at Darden's higher-end chains rose 0.5% in the quarter.

Barington's portfolio has around a dozen companies at any given time. Earlier this year the hedge fund built up a stake in Jones Group Inc., JNY +0.56% pushing for the retailer to reduce costs, add directors and sell parts of its portfolio. Jones is now in the late stages of an auction of the entire company, according to people familiar with the matter.

In 2006, the fund contacted apparel maker Warnaco Group Inc.'s management and suggested that the company sell non-core brands and reduce expenses. Warnaco later sold its Anne Cole, Ocean Pacific and other brands.

WWD : Nike Projects $10B in Apparel Sales by 2017

Nike Inc. has set the performance bar high.

Mark Parker, president and chief executive officer, said the company could add nearly $11 billion in sales by 2017, raising its revenues to $36 billion.

And a big part of that will come from apparel, which is expected to keep pace with its growth in recent years and add $3 billion in sales by 2017, expanding to more than $10 billion in annual revenue. Nike-branded apparel has been growing by nearly 40 percent over the past three years.

"We’ve been growing our women’s [apparel] business faster than we have our men’s business," Parker said at a meeting with investors.

The ceo and other executives were pitching the athletic giant, which already has over $25 billion in sales, as a growth company.

"There is more opportunity for Nike today than at any point in our history," Parker said. "Over the next decade, we will see the world’s middle class grow by over one billion consumers." Much of this growth will come from countries such as Brazil, Russia, India and China.

Trevor Edwards, president of the Nike brand, said the brand’s strength flowed from its focus on sports, which provides both excitement and technical inspiration as it seeks to meet the performance needs of top athletes.

"Sport is a powerful force," Edwards said. "It transcends the boundaries of distance, of language, of culture. Every single year gives us the new hope of a freshman class, the promise of a new phenomenal athlete and the anticipation of a new team on the cusp of greatness. The Nike brand lives and thrives with this … energy of sport."

The brand is also plotting rapid expansion on line.

Edwards projected that sales on nike.com would quadruple to $2 billion for 2017, up from sales of $540 million during the fiscal year ended May 31.

"The consumer landscape continues to see tectonic shifts created by the impact of digital," Edwards said. "The young consumer lives in a digital world. Digital is like oxygen. It’s omnipresent and indispensible. It’s everywhere and it’s always on."

>>> MINUTES OF THE SEPT 18 FOMC MEETING: SOME MEMBERS WORRIED THAT TAPER WOULD INCREASE MARKET RATES; TAPER WAS A CLOSE CALL FOR MANY VOTING MEMBERS

MINUTES OF THE SEPT 18 FOMC MEETING: SOME MEMBERS WORRIED THAT TAPER WOULD INCREASE MARKET RATES; TAPER WAS A CLOSE CALL FOR MANY VOTING MEMBERS - Officials who were against tapering were disappointed by recent figures, many wanted a cautious path toward slowing of bond purchases - meeting participants regarded the information received during the intermeeting period as indicating that economic activity had continued to expand at a moderate pace, albeit somewhat more slowly than earlier anticipated, and they generally indicated that the broad contours of the outlook further out had not changed materially since their July meeting - In discussing labor market developments, a number of participants indicated that gains in payrolls in the July and August employment reports were disappointing, but one participant also noted that seasonal adjustment tended to be challenging during the summer months. - Despite the continued improvement in household balance sheets, a number of factors were mentioned as possible restraints on spending, including declines in consumer confidence, concerns about job security and availability, and the lingering effects of this year's payroll tax increase - While downside risks to the outlook for the economy and the labor market were generally viewed as having diminished, on balance, since last fall, a number of significant risks remained, including those related to the potential economic effects of the sizable increases in interest rates since the spring, ongoing fiscal drag, and the possible fallout from near-term fiscal debates

- reference: {http://www.federalreserve.gov/monetarypolicy/fomcminutes20130918.htm}

(BN) Alitalia Said to Consider More Than Doubling Capital Increase

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Alitalia Said to Consider More Than Doubling Capital Increase 2013-10-09 15:47:42.74 GMT

By Tommaso Ebhardt and Chiara Vasarri Oct. 9 (Bloomberg) -- Alitalia SpA is set to propose more than doubling a planned capital increase to about 250 million euros ($338 million) as part of a financing package to keep the airline afloat, people familiar with the matter said. The airline’s board may approve the new capital injection as soon as tomorrow, said the people, who asked not to be identified because talks are private. An Italian state entity may join existing shareholders, including Air France KLM Group, in the capital increase, which is part of a 450 million-euro refinancing accord, the people said. Italian Prime Minister Enrico Letta is fighting against time to save the airline after energy company Eni SpA said it will halt fuel supplies on Oct. 12 unless Alitalia shows it is able to continue operations. The government is seeking a solution for the carrier before tomorrow’s board meeting, said three people familiar with the matter. Letta met with Alitalia representatives and some of its investors and creditors this week in a bid to avert a collapse, according to four people with knowledge of the plan. The 450 million-euro injection would consist of a capital increase and about another 200 million euros provided in bank financing, according to the people, adding the plan is still under review. An official at Alitalia declined to comment.

Premiere Push

Letta is pushing for a state-controlled company to invest in Alitalia and ease a combination with Air France-KLM Group or another carrier, the people said yesterday. The government is also trying to persuade shareholders to approve a plan to raise capital to avoid a liquidity crunch and make Alitalia a more appealing partner after Air France-KLM, its biggest shareholder, has been hesitant to come to its rescue. Alitalia’s board will reconvene in Rome at 5 p.m. tomorrow, after the carrier said following a board meeting yesterday that it needed more time to define rescue measures. Alitalia is confident its “financial condition will improve Alitalia’s board on Sept. 26 approved a capital increase of least 100 million euros as its cash has dwindled following the heavier first-half net loss. The priority is to resolve the cash issue through new financing and a capital increase before combining with an international player, the people said. Air France is under pressure itself to cut costs, and its French subsidiary plans to eliminate 1,826 ground-staff jobs through voluntary employee departures to address weaker demand.

For Related News and Information: Italy Said to Seek State Funds to Ease Alitalia Combination NSN MUD2MQ6K50YE <GO> Italy May Subscribe to Alitalia Convertible Bond: Corriere NSN MUE2FM6S972L <GO> News on airlines: NI AIR BBG <GO> Top transport news: TOP TRN <GO> BI European airline index: BIAIREUT <Index> <GO>

--Editors: Benedikt Kammel, Jacqueline Simmons

To contact the reporters on this story: Tommaso Ebhardt in Milan at +39-02-8064-4231 or tebhardt@bloomberg.net; Chiara Vasarri in Rome at +39-06-4520-6325 or cvasarri@bloomberg.net

To contact the editors responsible for this story: Chad Thomas at +49-30-70010-6232 or cthomas16@bloomberg.net; Jerrold Colten at +39-02-8064-4261 or jcolten@bloomberg.net