An FDA decision about another drug makers Duchenne muscular dystrophy therapy is spelling bad news for Sarepta Therapeutics (SRPT).
The FDA declined a request from Swiss biotech Santhera for accelerated approval of Raxone, its treatment for the rare disorder. The agency said the drug company needs to perform another study to confirm previous results.
Sarepta, meanwhile, is awaiting an FDA decision of its own on accelerated approval for the drug eteplirsen. And RBC Capital Markets says todays news bodes poorly for the drug maker.
Even though there are multiple differences between the Santhera and Sarepta drugs and datasets (most of which favor Santhera, by the way), we do see a direct negative read-through to the Sarepta decision from todays news. We believe todays news makes a positive decision on eteplirsen even more unlikely.
But Debjit Chattopadhyay at Janney disagrees.
Santhera’s drug (Raxone) aimed at improving lung function in all Duchenne patients has now being pushed out to 2020 and could negatively impact market sentiment in Sarepta shares; however, unlike eteplirsen, Raxone is not positioned as disease modifying therapy. Preliminary Raxone claims were in patients unable to tolerate glucocorticoids, but the FDA wants data in combination with glucocorticoids prior to NDA acceptance. Unlike Santhera, disease modifying ability, patient advocacy, and significant political pressure are principle reason the accelerated approval window is still open for Sarepta.
Top Communications Equipment Companies To Watch In Right Now: Frontier Communications Corporation(FTR)
Frontier Communications Corporation, a communications company, provides regulated and unregulated voice, data, and video services to residential, business, and wholesale customers in the United States. The company offers residential services, such as fiber-to-the-home and fiber-to-the-node broadband, video, and voice over Internet protocol products, as well as traditional copper-based broadband products; and commercial services, including Ethernet, dedicated Internet, multiprotocol label switching, time division multiplexing, data transport services, and optical transport services. It also provides Frontier Secure suite of products for computer security, cloud backup and sharing, identity protection, equipment insurance, and technical support; unified messaging services comprising call forwarding, conference calling, caller identification, voicemail, and call waiting services; long distance network services; and packages of co mmunications services. In addition, the company offers switched access services that facilitate other carriers to use the companys facilities to originate and terminate their local and long distance voice traffic; satellite TV video services; a range of third-party communications equipment to small, medium, and enterprise business customers; and directories. As of December 31, 2014, it had approximately 3,214,800 residential customers; approximately 304,700 business customers; 2,373,900 broadband subscribers; and 586,600 video subscribers. The company was formerly known as Citizens Communications Company and changed its name to Frontier Communications Corporation in July 2008. Frontier Communications Corporation was founded in 1927 and is based in Norwalk, Connecticut.
- [By WilliamBriat]
Frontier Communications Corporation (NASDAQ: FTR) provides phone, Internet, and satellite TV (through a partnership with DISH Network) services to more than 25 states. The company provides an annual dividend of 9.3% and reaffirmed its full-year guidance.
Top Communications Equipment Companies To Watch In Right Now: Sina Corporation(SINA)
SINA Corporation provides online media and mobile value-added services (MVAS) in the People?s Republic of China. It provides advertising, non-advertising, and free services through SINA.com, Weibo.com, and SINA Mobile. SINA.com offers free interest-based channels that provide region-focused format and content, including news, sports, automobile-related news, finance, entertainment, luxury, technology, digital, tools, collectibles, video, music, and wireless application protocol, as well as interactive platform for fashion-conscious users to share comments and ideas on a range of topics, such as health, cosmetics, and beauty. The company’s microblogging platform, Weibo.com, enables its users to follow the hottest topics being discussed online, as well as discussions related to people they know. Weibo accounts consist of celebrities, commercial enterprises, government entities, and grass root Internet users. Its SINA Mobile service allows users to receive news and informatio n, download ring tones, mobile games and pictures, and participate in dating and friendship communities. The company also offers SINA Game, which serves as an interactive platform that provides users with downloads and gateway access to popular online games; SINA eReading, a shop for book reviews; SINA.net, an enterprise solutions platform to assist businesses and government bodies; and SINA Mall, an online shopping Website. In addition, it provides a platform for Chinese bloggers; photo-sharing platform; free email, VIP mail, and corporate email for enterprise users; audio and video-based instant messaging tools; proprietary search technology; and classified advertising services, as well as hosts topic-specific discussion forums in Chinese language; and creates user-maintained and supported online communities. The company has strategic cooperation agreement with China Unicom (Hong Kong) Limited. SINA Corporation was founded in 1997 and is headquartered in Shanghai, the Peo p le?s Republic of China.
- [By Monica Gerson]
SINA Corp (NASDAQ: SINA) is projected to post a quarterly loss at $0.05 per share on revenue of $189.47 million.
Eldorado Gold Corp (USA) (NYSE: EGO) is expected to post a quarterly loss at $0.01 per share on revenue of $188.91 million.
Top Income Stocks To Own Right Now: Smith & Nephew SNATS, Inc.(SNN)
Smith & Nephew plc develops, manufactures, markets, and sells medical technology products and services worldwide. The company offers sports medicine joint repair products for surgeons, including an array of instruments, technologies, and implants necessary to perform minimally invasive surgery of the joints; and arthroscopy enabling technologies for healthcare providers, such as fluid management equipment for surgical access, high definition cameras, digital image capture, scopes, light sources, and monitors to assist with visualization inside the joints, radio frequency wands, electromechanical and mechanical blades, and hand instruments for removing damaged tissue. It also provides trauma and extremities products consisting of internal and external devices used in the stabilization of severe fractures and deformity correction procedures; gynecological instrumentation devices; knee implant products for specialized knee replac ement procedures; and hip implant products for reconstruction of the hip joint, as well as various products and technologies to assist in surgical treatment of the ear, nose, and throat. In addition, the company offers advanced wound care products for the treatment of acute and chronic wounds, including leg, diabetic and pressure ulcers, burns, and post-operative wounds; advanced wound devices, including traditional and single-use negative pressure wound therapy and hydrosurgery systems; and biologics and other bioactive technology products for debridement and dermal repair/regeneration. The company primarily serves the providers of medical and surgical treatments and services. Smith & Nephew plc was founded in 1856 and is headquartered in London, the United Kingdom.
- [By Charles Carlson, CEO and Portfolio Manager, Horizon Investment Services]
For investors looking for growth but also income, I especially like three health-care related stocksFresenius Medical (FMS), Novo Nordisk (NVO), and Smith & Nephew (SNN).
Top Communications Equipment Companies To Watch In Right Now: Enbridge Inc(ENB)
Enbridge Inc. operates as an energy transportation and distribution company in the United States and Canada. Its Liquids Pipelines segment operates common carrier and contract crude oil, natural gas liquids (NGL), and refined products pipelines and terminals. The companys Gas Distribution segment operates as a natural gas utility that serves residential, commercial, and industrial customers in Central and Eastern Ontario, and Northern New York State, as well as in Quebec and New Brunswick. Its Gas Pipelines, Processing and Energy Services segment has interests in natural gas pipelines, including the Vector Pipeline and transmission and gathering pipelines in the Gulf of Mexico, as well as holds an interest in Aux Sable, a natural gas fractionation and extraction facility. This segment is also involved in the renewable energy projects, such as wind, solar, and geothermal projects with a generating capacity of approximately 2, 800 MW. The companys Sponsored Investments segment is involved in renewable and alternative power generation; crude oil and liquid petroleum transportation and storage; and natural gas and NGL gathering, treating, processing, and transportation. Enbridge Inc. has a strategic partnership with EDF Group for the development, construction, and operation of three French offshore wind farms. The company was formerly known as IPL Energy Inc. and changed its name to Enbridge Inc. in October 1998. Enbridge Inc. was founded in 1949 and is headquartered in Calgary, Canada.
- [By Callum Turcan]
Bridging the way
Enbridge (NYSE: ENB ) currently carries 2.2 million barrels of crude oil and liquidseach day through its vast 15,372 thousand mile pipeline system.Enbridge has recently undergonea $6.2 billion program to grow shipping capacity in Western Canada and the Bakken by 400,000 bpd. Western Canada is home to the booming oil sands play, so Enbridge is trying to capitalize on two high-growth markets.
Top Communications Equipment Companies To Watch In Right Now: Heartware International, Inc.(HTWR)
Heartware International, Inc., incorporated on June 29, 2008, is a medical device company. The Company develops and manufactures miniaturized implantable heart pumps or ventricular assist devices to treat patients suffering from advanced heart failure. The Company operates in the segment of design and manufacture of medical devices. The HeartWare Ventricular Assist System (HVAD System), which includes a ventricular assist device (VAD) or blood pump, patient accessories and surgical tools, provides circulatory support for patients in the advanced stage of heart failure. The HVAD System is designed to be implanted adjacent to the heart, avoiding abdominal surgery. The HVAD System features the centrifugal pump designed to be implanted in the chest, directly adjacent to the heart.
The HeartWare HVAD System
The HVAD System consists of HVAD pump, a permanently implantable VAD, patient accessories and surgical tools. The HVAD pump is capable of generatin g over 10 liters of blood flow per minute. With a displaced volume of approximately 50 cubic centimeters and a mass of over 140 grams, the HVAD pump is implantable in the pericardial space, directly adjacent to the heart. The pump’s inflow cannula is integrated with the device itself, providing proximity between the heart and the pumping mechanism, facilitating ease of implant and helping to ensure optimal blood flow characteristics. The use of a wide-bladed impeller and the clear flow paths through the pump are designed to help reduce the risk of pump-induced damage to blood cells.
The HeartWare MVAD System
The MVAD System consists of similar components, surgical tools and peripherals, as the HVAD System, but is differentiated by the MVAD pump. The MVAD pump is a miniaturized blood pump intended for patients with chronic heart failure. The device is a full-output axial-flow pump with a fully suspended rotor and a displacement volume of less than on e-half of that of the HVAD pump.
The CircuLite ! System
The CircuLite Surgical System is designed to be implanted through a right, mini-thoracotomy procedure and does not require a sternotomy or cardiopulmonary bypass. The CircuLite Circulatory Support System offers interventional options to earlier-stage heart failure patients.
The Company competes with St. Jude Medical, Inc., Jarvik Heart, Inc., ReliantHeart Inc., Berlin Heart GmbH and Sunshine Heart, Inc.
- [By Spencer Israel]
4. HeartWare International Inc (NASDAQ: HTWR) – The heart device maker agreed to be acquired by Medtronic for $58 per share in cash two weeks ago. Prior to that the stock had been trading just above $30.