Results from 306 B, a large phase III study demonstrating improvement in dizziness / lightheadness, the main symptom of NOH and confirming findings from the previous 301 study, was included in the resubmitted NDA.
Chelsea Therapeutics had initially submitted an NDA for Northera in Sep 2011. However, the company received a complete response letter (CRL) in Mar 2012. In the CRL, the FDA recommended that Chelsea Therapeutics should conduct and submit data from an additional positive study supporting efficacy in the 301 study. The company was also asked to design a study which would demonstrate durability of effect over a 2- to 3-month period.
Top 5 Energy Companies To Buy Right Now: Coca Cola Femsa S.A.B. de C.V. (KOF)
Coca Cola FEMSA, S.A.B. de C.V. produces, markets, and distributes Coca-Cola trademark beverages and brands. It offers colas under Coca-Cola, Coca-Cola Light, and Coca-Cola Zero brands; flavored sparkling beverages under Aquarius Fresh, Chinotto, Crush, Fanta, Fresca, Frescolita, Hit, Kuat, Lift, Mundet, Quatro, Simba, and Sprite brands; water under Alpina, Brisa, Ciel, Crystal, Kin, Manantial, and Nevada brands; Aquarius, a flavored water; Hi-C, a juice-based beverage; and Powerade, an isotonic, as well as ready to drink tea products under Nestea and Matte Leao brands. The company also sells and distributes the Kaiser beer brand. It operates in Mexico, Central America, Colombia, Venezuela, Brazil, and Argentina. The company was founded in 1979 and is based in Mexico, Mexico. Coca-Cola FEMSA S.A.B de C.V. operates as a subsidiary of Fomento Economico Mexicano, S.A.B. de C.V.
Advisors' Opinion:- [By Eric Volkman]
Put another tick in the acquisition column for Coca-Cola FEMSA (NYSE: KOF ) . The Mexico-based company, which says it is the largest bottler of Coca-Cola products on the planet, has signed a deal to acquire Brazilian peer Companhia Fluminense de Refrigerantes. The price is $448 million in cash.
Best High Tech Companies To Watch In Right Now: ACADIA Pharmaceuticals Inc.(ACAD)
ACADIA Pharmaceuticals Inc., a biopharmaceutical company, focuses on drug discovery and clinical development of novel treatments for central nervous system disorders. The company has a portfolio of four product candidates, including pimavanserin, which is in Phase III clinical development as a treatment for Parkinson's disease psychosis. It is also developing AGN-XX/YY, a product candidate in Phase II for chronic pain; and AC-262271, a product candidate in Phase I for glaucoma in collaboration with Allergan, as well as AM-831, a product candidate in IND-track development in collaboration with Meiji Seika Kaisha, Ltd. In addition, ACADIA Pharmaceuticals Inc. is developing two preclinical programs in the area of Parkinson?s disease. The product candidates in the company?s pipeline emanate from discoveries made using its proprietary drug discovery platform. The company was founded in 1993 and is headquartered in San Diego, California.
Advisors' Opinion:- [By Rich Duprey]
Shortcut to approval
It was FDA action that also caused ACADIA Pharmaceuticals (NASDAQ: ACAD ) to rocket 64% higher and become the best performing stock on the market. It was allowed to bypass a second late-stage trial for its Parkinson's disease psychosis treatment pimavanserin. As the Fool's Brian Orelli notes, while ACADIA still has to perform tests for drug-drug interaction and chemistry and manufacturing -- so it won't be submitting its new drug application before next year -- the elimination of the confirmatory trial speeds up the time to market dramatically. - [By Rick Munarriz]
Tuesday
ACADIA Pharmaceuticals (NASDAQ: ACAD ) checks in on Tuesday. The biotech company's lead candidate is pimavanserin, a promising drug that's in the third and final phase of clinical development as a treatment for Parkinson's disease psychosis. Naturally, investors see red ink here, but analysts do see the quarterly deficit narrowing this time around.
Best High Tech Companies To Watch In Right Now: Descartes Systems Group Inc (DSGX)
The Descartes Systems Group Inc. (Descartes) is a global provider of federated network and global logistics technology solutions that help its customers make and receive shipments and manage related resources. The Company�� network-based solutions, which primarily consist of services and software, connect people to their trading partners and enable business document exchange (bookings, bills of lading and status messages); regulatory compliance and customs filing; route and resource planning, execution, monitoring and reporting; inventory and asset visibility; rate and transportation management, and warehouse operations. Its pricing model provides its customers solutions either on a perpetual license, subscription or transactional basis. In December 2013, the Company acquired Compudata and Impatex Freight Software Limited.
The Company�� focus is on serving transportation providers (air, ocean and truck modes), logistics service providers (including third-party logistics providers, freight forwarders and customs brokers) and distribution-intensive companies. To help deliver the resources in motion management solutions (RiMMS) solutions to customers, Descartes developed the Logistics Technology Platform. Descartes��Logistics Technology Platform is synthesis of network, applications and community. The Logistics Technology Platform fuses Descartes��Global Logistics Network (GLN), logistics networks covering multiple transportation modes, with an array of modular, interoperable Web and wireless logistics management applications.
The applications available over the Logistics Technology Platform that work in conjunction with the GLN, help transportation companies and logistics service providers (LSPs) control their shipment management process, comply with regulatory requirements, expedite cross-border shipments and connect and communicate with their trading partners. Applications are also available on the Logistics Technology Platform to help manufacturer, retailer, distribu! tor and mobile service provider (MRDM) enterprises. Its applications are designed to support global trade and compliance systems (GT&C), which encompasses the preparation and filing of the necessary electronic documentation relating to a shipment, such as cross-border customs documentation, freight waybills or manifests; supply chain execution (SCE), which entails the processes related to managing shipments from their point of origin to their point of destination, as well as the documents related to those shipments (booking data, orders, contracts and rates, shipment status, proof of delivery, invoices and payments), and mobile resource management applications (MRM), which involves tracking, information gathering, measuring, reporting, compliance filing, delegating and optimizing the use of mobile assets and people that are involved in the movement of goods.
The Logistics Technology Platform supports a community of over 35,000 trading partners sending over one billion messages annually in over 160 countries. Designed specifically for logistics processes and their users, the Logistics Technology Platform enables organizations to centrally manage information, deliver messages and transform data.Customers use its modular, software-as-a-service solutions to route, schedule, track and measure delivery resources; plan, allocate and execute shipments; rate, audit and pay transportation invoices; file customs and security documents for imports and exports.
Advisors' Opinion:- [By CRWE]
Descartes Systems Group (Nasdaq:DSGX), the global leader in uniting logistics-intensive businesses in commerce, reported that Salient Management Company, a leading provider of performance management solutions, has selected Descartes’ advanced geographic information system (GIS) platform for incorporation into Salient’s performance management solution.
- [By Rich Smith]
Waterloo, Ontario-based Descartes Systems Group (NASDAQ: DSGX ) has acquired KSD Software Norway AS, a company described as a "leading Scandinavia-based provider of electronic customs filing solutions for the European Union ('EU')."
Best High Tech Companies To Watch In Right Now: Brookfield Residential Properties Inc (BRP)
Brookfield Residential Properties Inc. (Brookfield Residential) is a land developer and homebuilder.The Company entitles and develops land and builds homes for its own communities, as well as sells lots to third-party builders. It operates in three segments in North America: Canada, California and Central and Eastern U.S. Each of the Company�� segments specializes in lot entitlement and development and the construction of single-family and multi-family homes. As of December 31, 2011, Brookfield Residential controlled 108,197 lots. The Company became a public company on March 31, 2011, by combining the former business of Brookfield Homes Corporation (Brookfield Homes) and the residential land and housing division (BPO Residential) of Brookfield Office Properties Inc. into a single residential land and housing company, achieved through a merger and series of related transactions completed on March 31, 2011. Advisors' Opinion:- [By Dimitra DeFotis]
In the homebuidling category:
Weyerhaeuser (WY), the producer of lumber, was up nearly 3%. On Thursday, Citigroup Analyst Anthony Pettinari wrote that Weyerhaeuser could sell its homebuilder unit for between $2.5 billion and $3.5 billion, and interested buyers in the unit, WRECO, could include Lennar�(LEN), Toll Brothers (TOL) and Brookfield Residential Properties (BRP). About 67% of the Weyerhaeuser unit’s roughly 27,000 lots are in California. Citi has a Buy rating on Weyerhauser and a $35 price target. Lennar, the home builder, was�up 2.6%. Masco (MAS), the building materials maker, was�up 2%.� PulteGroup (PHM), the home builder, was�up 2%. DR Horton�(DHI), the home builder, was�up 1.9%.Among real estate trusts:
- [By Ben Levisohn]
In terms of specific company upside/downside payoffs, we believe that [Brookfield Residential Properties (BRP)], [KB Home], and [PulteGroup] offer above-average payoffs. We note that more than half of [Brookfield Residential Properties'] earnings are derived from Canada, dampening EPS sensitivity to our assumptions regarding the pace of the U.S. housing recovery. We believe that [KB Home] will achieve sharply improved operating performance, which should drive robust EPS growth given the company�� comparatively high degree of financial leverage. We also have a high degree of confidence that�[PulteGroup] will continue to successfully execute against its goal of improving ROIC performance, which should act as a catalyst for share price appreciation.
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