Last week we focused on five can't-miss earnings reports. This week, we're going to turn the tables back to the Food and Drug Administration and focus on a PDUFA decision and an FDA panel review slated for this week.
First up is Raptor Pharmaceuticals (NASDAQ: RPTP ) with Procysbi (previously known as RP-103), its oral delayed and extended-release medication to treat nephropathic cystinosis. In trials, Procysbi proved to be non-inferior to the only other FDA-approved treatment for nephropathic cystinosis, known as Cystagon from Mylan (NASDAQ: MYL ) .
As my Foolish colleague Keith Speights has already pointed out, both Procysbi and Cystagon are two different forms of cysteamine bitartate. However, Cystagon comes with the need to be taken four times daily (meaning sleep schedules can and will get interrupted) and has a slew of other potential side effects. Procysbi, on the other hand, needs only to be taken twice daily and has milder side effects.
10 Best Heal Care Stocks To Invest In 2015: H.J. Heinz Company (HNZ)
H. J. Heinz Company manufactures and markets food products for consumers, and foodservice and institutional customers in North America, Europe, the Asia Pacific, and internationally. The company primarily offers ketchup, condiments and sauces, frozen food, soups, beans and pasta meals, infant nutrition, and other food products. It sells its products through its sales organizations, independent brokers, agents, and distributors to chain, wholesale, cooperative, and independent grocery accounts; convenience stores; bakeries; pharmacies; mass merchants; club stores; foodservice distributors; and institutions, including hotels, restaurants, hospitals, health-care facilities, and government agencies. The company was founded in 1869 and is based in Pittsburgh, Pennsylvania.Advisors' Opinion:
- [By Eric Volkman]
It's official: Warren Buffett is the new Master of Ketchup. In a special meeting convened for the purpose, H.J. Heinz (NYSE: HNZ ) stockholders today voted overwhelmingly in favor of being acquired by a consortium led by the veteran investor�Berkshire Hathaway (NYSE: BRK-A ) (NYSE: BRK-B ) . Roughly 95% of the votes, representing around 60% of Heinz's outstanding stock, were in support of the buyout.
- [By Matt Koppenheffer]
On negative implications of the H.J. Heinz� (NYSE: HNZ ) �deal.�A questioner wondered whether Berkshire's preferred position in the Heinz deal and the high price paid suggested that Buffett isn't optimistic about the returns available in the market. Buffett responded simply that that was "totally inaccurate." Munger later added on: "As you said, the report was totally wrong."
- [By Eric Volkman]
McGraw-Hill Financial's (NYSE: MHFI ) S&P Dow Jones Indices has brought in a pair of big-name stocks to replace issues on two of its signature products. After the close of trading on June 6, both the S&P 100 and the 500 will be home to General Motors (NYSE: GM ) . The stock replaces Heinz (NYSE: HNZ ) , which was recently acquired by a consortium led by Berkshire Hathaway (NYSE: BRK-B ) .
- [By Tim Brugger]
An investment consortium comprised of Berkshire Hathaway (NYSE: BRK-A ) and a 3G Capital investment fund has completed the acquisition of H.J. Heinz (NYSE: HNZ ) for $72.50 per share and a new CEO has taken over Heinz, the company announced today.
Top 5 Food Companies To Own For 2014: Star Scientific Inc (STSI)
Star Scientific, Inc. (Star Scientific), incorporated on June 24, 1985, is engaged in the manufacturing and production of dietary supplements. The Company�� operating subsidiaries manufacture, distribute and sell consumer products and dietary supplements. Its segment includes dietary supplements. Through its Rock Creek Pharmaceuticals, Inc. (Rock Creek) subsidiary, the Company is engaged in the manufacture, sale, marketing and development of non-nicotine nutraceutical, dietary supplements: Anatabloc, for anti-inflammatory support; the manufacture, sale and marketing of a cosmetic facial cream, and the development of other nutraceuticals, dietary supplements and pharmaceutical products. On December 14, 2012, the Company voted to discontinue the manufacturing, distribution and sale of its dissolvable smokeless tobacco products, Ariva and Stonewall Hard Snuff, as of December 31, 2012. With this change it will no longer be manufacturing or selling any tobacco products.
Rock Creek Pharmaceuticals has been engaged in the development of other dietary supplements and pharmaceutical products, particularly products that have a botanical- based component and that are designed to provide nutritional support in a range of neurological conditions, including Alzheimer�� disease, Parkinson�� disease, schizophrenia, depression, and Hashimoto�� thyroiditis. Rock Creek Pharmaceuticals also has been involved in the development of a cosmetic line of products that utilizes its anatabine compound to improve the appearance of the skin. On September 10, 2012, the Company introduced Anatabloc Facial Creme into the market. As of November 9, 2012, Anatabloc was being sold through its interactive Website, a customer service center and on a consignment basis through GNC, which is a retailer of dietary supplements. The Company uses its anatabine citrate compound in its dietary supplements Anatabloc and Anatabloc Unflavored and its anatabine-based cosmetic product, Anatabloc Facial Creme.Advisors' Opinion:
- [By Jake L'Ecuyer]
Consumer goods stocks were underperformers in Tuesday's trading, up on the day by just 0.5% compared to S&P's 1.03 percent gain. Among the consumer goods stocks, shares of Star Scientific (NASDAQ: STSI) were down by more than 1 percent.
- [By Bryan Murphy]
A week and a half ago I posted a bullish - though condition - commentary on Star Scientific, Inc. (NASDAQ:STSI). Truth be told, I expected that potential bullishness to be unleashed a few days later. When it didn't unfurl, frankly, I started to forget about STSI. Fortunately I didn't completely put the stock on the shelf, because it finally formed that technical catalyst yesterday, and followed-through today.
For those who caught my first look at STSI, you may recall that the big catalyst was the horizontal ceiling at $2.11. That was where the stock peaked in mid-July, and that's also where it was peaking on the same day I penned my prior bullish comments. Sure enough, Star Scientific shares peeled back from there later in the same day. The stock tested $2.11 again on the 9th, and once again peeled back. By the time we got that third test/failure cycle logged, however, it was clear something was changing... for the better.
- [By Bryan Murphy]
To say that Star Scientific, Inc. (NASDAQ:STSI) has become one of the market's most contentious stocks lately would be an understatement. Less than two days after shares finally broke above a key line in the sand at $2.11, a fairly scathing piece was posted that (and probably solely intended to do so) knocked STSI back under that key level, deflating any of the newly-developed bullishness surrounding the nutritional supplement company.
Top 5 Food Companies To Own For 2014: Hellenic Sugar Industry SA (HSI)Hellenic Sugar Industry SA is a Greece-based company engaged in the production and trade of white crystal sugar and its by-products, such as molasses and sugar beet seed. Its principal activities include the manufacture of all types of sweetener products and general kneading products; the production and processing of sugar beet and other plants; the production of raw materials for sugar production; the establishment, equipping and exploitation of sugar producing factories; conducting scientific research in all fields of activity of the Company; the trade and standardization of sugar products, by-products, raw materials, multiple materials, agricultural products and machinery, and carrying out agro-industrial activities in Greece and abroad. The Company has five sugar factories and one seed processing factory in Greece. Advisors' Opinion:
- [By Yoshiaki Nohara]
Hong Kong�� Hang Seng Index (HSI) declined 3.4 percent, extending its run of weekly losses to six, the longest streak since the global financial crisis of 2008. China�� Shanghai Composite Index dropped 4.1 percent, and a gauge of mainland firms listed in Hong Kong retreated 4.5 percent.
Top 5 Food Companies To Own For 2014: 1-800 FLOWERS.COM Inc.(FLWS)
1-800-Flowers.com, Inc. together with its subsidiaries, operates as a florist and gift retailer in the United States. The company offers a range of products, including fresh-cut flowers, floral arrangements and plants, gifts, popcorn, gourmet foods and gift baskets, cookies, chocolates, candy, and wine through its telephonic and online sales channels, company-owned and operated retail floral stores, and franchised stores. It provides gourmet gifts, such as popcorn and specialty treats through thepopcornfactory.com; cookies and baked gifts through cheryls.com; chocolates and confections through fanniemay.com and harrylondon.com; gift baskets and towers through 1800baskets.com; Celebrations brand party ideas and planning tips through celebrations.com; and customizable invitations, announcements, and greeting cards through finestationery.com. As of July 3, 2011, the company operated 2 floral retail stores, 1 fulfillment center, and approximately 100 franchised stores located within the United States. It has strategic online relationships with Facebook, Google, AOL, Yahoo!, and Microsoft. The company was founded in 1976 and is headquartered in Carle Place, New York.Advisors' Opinion:
- [By Equities Lab]
The stocks that currently pass the stock screen in order of market cap are Frontier Communications Corp , Crown Media Holdings (CRWN), Vonage Holding (VG), MCG Capital Corp (MCGC), 1-800-FLOWERS.COM (FLWS), MTR Gaming Corporation (MNTG), Alaska Communications (ALSK), and Enzon Pharmaceuticals (ENZN).
- [By Garrett Cook]
Cyclical consumer goods & services shares fell by just 0.30 percent in trading on Friday. Top gainers in the sector included ULTA Salon, Cosmetics & Fragrance NASDAQ: (ULTA), up 18.6 percent, and 1-800-Flowers.com (NASDAQ: FLWS), up 4.6 percent.
- [By Garrett Cook]
Toward the end of trading Friday, the Dow traded down 0.60 percent to 16,947.43 while the NASDAQ declined 0.75 percent to 4,557.59. The S&P also fell, dropping 0.83 percent to 1,980.97.Leading and Lagging Sectors Cyclical consumer goods & services shares fell by just 0.50 percent in trading on Friday. Top gainers in the sector included ULTA Salon, Cosmetics & Fragrance NASDAQ: (ULTA), up 17.5 percent, and 1-800-Flowers.com (NASDAQ: FLWS), up 4.5 percent. In trading on Friday, utilities shares were relative laggards, down on the day by about 1.89 percent. Meanwhile, top decliners in the sector included Companhia Energética de Minas Gerais - CEMIG (NYSE: CIG), down 4.7 percent, and CPFL Energia SA (NYSE: CPL), off 4.3 percent. Top Headline Darden Restaurants (NYSE: DRI) reported better-than-expected fiscal first quarter earnings. The Orlando, Florida-based company reported a quarterly loss of $19.3 million, or $0.14 per share, versus a year-ago profit of $42.2 million, or $0.32 per share. Excluding non-recurring items, the company earned $0.32 per share. Its sales surged to $1.6 billion versus $1.53 billion. However, analysts were expecting earnings of $0.30 per share on revenue of $1.6 billion. Equities Trading UP Conversant (NASDAQ: CNVR) shares shot up 30.25 percent to $34.79 after Alliance Data Systems (NYSE: ADS) announced its plans to buy Conversant for $35 per share. Shares of ULTA Salon, Cosmetics & Fragrance (NASDAQ: ULTA) got a boost, shooting up 17.69 percent to $114.72 after the company reported upbeat second-quarter results and raised its outlook. The company also unveiled a five-year plan for impressive growth. Sportsman's Warehouse Holdings (NASDAQ: SPWH) shares were also up, gaining 15.89 percent to $7.00 after the company reported stronger-than-expected fiscal second-quarter results. Equities Trading DOWN Shares of Ruckus Wireless (NASDAQ: RKUS) were down 5.19 percent to $14.35. Buckingham
- [By Laura Brodbeck]
Earnings Expected From: 1-800 Flowers.com, Inc (NASDAQ: FLWS)
Economic Releases Expected:�Eurozone unemployment rate, Italian CPI, Greek retail sales, French consumer spending, Canadian GDP.