Amarin Corporation plc (NASDAQ:AMRN): As previously disclosed, in each of mid-August and mid-September, the FDA communicated to Amarin that it had not yet made a determination with respect to Amarin’s pending request for five-year, new chemical entity exclusivity for Vascepa, and the cumulative supplements to the Orange Book published shortly thereafter, respectively, did not include an entry with respect to the regulatory exclusivity of Vascepa.Based on information available to Amarin, the FDA has not yet made a determination with respect to regulatory exclusivity for Vascepa. In mid-October, the FDA is expected to publish the September 2012 cumulative supplement to the Orange Book. In recent months, Amarin has repeatedly followed up with the FDA seeking a determination. While Amarin continues to believe its arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with Amarin’s arguments. Based on Amarin’s dialogue with the FDA, Amarin does not know what determination the FDA will make on the pending Vascepa exclusivity request or when the FDA will make such determination. If Vascepa is not awarded five-year marketing exclusivity, Amarin expects it will be awarded three-year marketing exclusivity. Amarin continues to anticipate commercial launch of Vascepa in the first quarter of 2013, and continues to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support.
Yum! Brands, Inc. (NYSE:YUM): Fast-food heavyweight Yum! Brands (YUM) reported better than expected third quarter results Tuesday afternoon. The firm saw revenue grow 9% year-over-year to $3.6 billion, roughly in-line with consensus expectations. Earnings jumped nearly 24% to $0.99 per share net of a one-time refranchising benefit, a few pennies better than consensus estimates.
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Costco Wholesale Corporation (NASDAQ:COST): Costco Wholesale (NASDAQ:COST) proves that the demise of the big-box store is exaggerated, reports the Wall Street Journal’s “Ahead of the Tape.” Fiscal Q4 numbers are due today and should underscore continued success. But investors have to pay above-market prices for that growth, about 80% more than the average 2012 earnings multiple of Wal-Mart (NYSE:WMT) and Target (NYSE:TGT). Hard to justify unless Costco’s superior performance can continue for many more years. The business model faces new competition, and the stock is fully priced. Costco’s shares are tempting to buy, but could lead to buyers’ remorse, the Journal says.
Wal-Mart Stores Inc. (NYSE:WMT): Wal-Mart Stores kicked Amazon out of its 4,000 stores last month when it discontinued Kindle tablets and e-readers. Now, the retailer is poised to use those stores against its online rival once again — this time aiming for the heart of Amazon’s retail model. Wal-Mart said Tuesday it had begun testing same-day delivery for online purchases in a handful of cities across the country. The near-instant delivery is possible because the merchandise is being shipped from Walmart stores.
True Religion Apparel Inc. (NASDAQ:TRLG): True Religion Apparel announced that after receiving indications of interest from third parties regarding a potential transaction with the company, the Board of Directors has formed a Special Committee comprised of its non-management directors to explore and evaluate potential strategic alternatives available to the company, including a possible sale, in order to maximize shareholder value. No decision has been made to engage in a transaction or transactions, and there can be no assurance that any transaction or any other strategic alternative will occur or, if undertaken, the terms or timing thereof. The Special Committee has not set a definitive timetable for completion of the strategic review process, and it does not intend to disclose or comment on developments with respect to the progress of such process until such time as the Board takes some action, if any, or otherwise deems disclosure appropriate or required. The Special Committee has engaged Guggenheim Securities, LLC as its financial advisor, and Greenberg Traurig, LLP as its legal counsel, to assist with the strategic review process.
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