With the�SPDR S&P Biotech Index�up 35% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
Taking a page right out of the old West, this week exposed the good, the bad, and the downright ugly of the biotech sector with regard to clinical data.
The good
Heralding the charge higher was AcelRx Pharmaceuticals (NASDAQ: ACRX ) which advanced 18% on the week after disclosing on Tuesday that its post-operative pain management system, Sufentanil NanoTab PCA, met its primary endpoint in late-stage trials and reconfirmed all previous late-stage study results. This data is strong enough for AcelRx to seek approval from the Food and Drug Administration with a new drug application filing expected next quarter. I'd be cautious with AcelRx moving forward, as the possibility of an FDA rejection for opioid-based treatments is always a possibility.
Top Tech Stocks To Own Right Now: COMS PLC ORD GBP0.001(COMS.L)
Coms plc engages in the development and commercialization of Internet telephony services, and supply and distribution of associated equipment to small and medium sized businesses in the United Kingdom. The company?s Internet telephony enables telephone calls to be transmitted as data over the Internet. It offers hosted VoIP, voice optimized broadband for business, PSTN CPS business telephone, audio and video conferencing, inbound numbers, number porting, and enterprise VoIP services. The company?s Internet telephony services related equipment comprises Internet telephony handsets, VOIP gateways, video phones, and integration consulting and SIP trunks. Coms plc was founded in 2000 and is based in London, the United Kingdom.
Top Tech Stocks To Own Right Now: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion: - [By James E. Brumley]
When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.
- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
TeleNav, Inc. provides personalized navigation and location based services (LBS) in the United States and internationally. It offers GPS Navigator, a voice guided, real time, turn by turn mobile navigation service on a white label basis, such as Sprint Navigation and AT&T Navigator, as well as under the TeleNav brand. The company also provides mobile resource management solutions that allow enterprises to monitor and manage mobile workforces and assets by using its LBS platform to track job status and the location of workers, field assets, and equipment. Its enterprise solutions include TeleNav Track service, as well as TeleNav Vehicle Manager, TeleNav Vehicle Tracker, and TeleNav Asset Tracker. In addition, the company offers mobile navigation services through on-board and connected systems. Further, it focuses on developing LBS to new device platforms, such as tablet devices, as well as new LBS for mobile phones, including location based mobile advertising, commerce, and social networking. The company distributes its services to consumers, wireless carriers, enterprises and automobile manufacturers, and original equipment manufacturers through its wireless carrier partners, as well as through its Web site and mobile phone application stores. TeleNav, Inc. is headquartered in Sunnyvale, California.
Advisors' Opinion: - [By Seth Jayson]
Telenav (Nasdaq: TNAV ) reported earnings on April 25. Here are the numbers you need to know.
The 10-second takeaway
For the quarter ended March 31 (Q3), Telenav beat expectations on revenues and beat expectations on earnings per share.
Top Tech Stocks To Own Right Now: GRAVITY Co. Ltd.(GRVY)
Gravity Co., Ltd. engages in the development and publishing of online games in Japan, Taiwan, Brazil, the Philippines, Indonesia, Singapore, Malaysia, Thailand, and the Russian Federation. It offers massively multiplayer online role playing games, casual online games, social network games, mobile games, and animation and character-based merchandise, as well as multiplatform and Internet protocol television games. The company?s principal product includes Ragnarok Online, an action adventure-based multiplayer online role playing game that combines cartoon-like characters, community-oriented themes, and combat features enabling various players to interact with one another. Its other multiplayer online role playing games comprise R.O.S.E. Online, Requiem, and Emil Chronicle Online. The company also licenses the merchandizing rights of character-related products based on its online games. In addition, it provides the animation series of Ragnarok Online in DVD and video on dema nd formats, as well as broadcasts these series on televisions. Further, the company, along with its licensees, markets dolls, stationery, and other character-based merchandise, as well as game manuals, monthly magazines, and other publications. Additionally, it offers Pororo Game, an Internet protocol television game. The company was founded in 2000 and is based in Seoul, Korea. As of December 31, 2010, Gravity Co., Ltd. operates as a subsidiary of GungHo Online Entertainment, Inc.
Top Tech Stocks To Own Right Now: Rexahn Pharmaceuticals Inc (RNN)
Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.
Archexin
Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.
Serdaxin
Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.
Zoraxel
Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.
The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.
Advisors' Opinion: - [By Roberto Pedone]
One under-$10 biopharmaceutical player that's just starting to move into breakout territory is Rexahn Pharmaceuticals (RNN), which is engaged in the development of novel treatments for cancer to patients. This stock has been on fire so far in 2013, with shares up sharply by 62%.
If you take a look at the chart for Rexahn Pharmaceuticals, you'll notice that this stock has been uptrending strong for the last month, with shares moving higher from its low of 36 cents per share to its intraday high of 53 cents per share. During that uptrend, shares of RNN have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of RNN into breakout territory above some near-term overhead resistance levels at 49 cents to 50 cents per share. It's worth noting that volume today is tracking in extremely strong with over 3 million shares traded, versus its three-month average action of 1.22 million shares.
Traders should now look for long-biased trades in RNN if it manages to break out above Thursday's intraday high of 53 cents per share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action of 1.22 million shares. If that breakout hits soon, then RNN will set up to re-test or possibly take out its next major overhead resistance levels at 64 cents to its 52-week high at 66 cents per share. Any high-volume move above 66 cents to 67 cents per share could then send RNN towards its next major overhead resistance levels at 81 cents per share.
Traders can look to buy RNN off any weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average at 47 cents per share. One can also buy RNN off strength once it clears 53 cents per share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By James E. Brumley]
With just a quick glance at a chart of Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), it would be easy to conclude it's nothing but a volatile mess. When you take a step back and look at a long-term weekly chart of RNN, however, it starts to become clear that this small cap biopharma name is on the verge of a monster-sized breakout. First things first, however.
Top Tech Stocks To Own Right Now: Cirrus Logic Inc.(CRUS)
Cirrus Logic, Inc., a fabless semiconductor company, develops high-precision analog and mixed-signal integrated circuits (ICs) for audio and energy markets worldwide. The company offers analog and mixed-signal audio converter and audio digital signal processor (DSP) products, which include analog-to-digital converters (ADCs); digital-to-analog converters (DACs); chips for integrating ADCs and DACs into an IC; digital interface ICs; volume controls; and digital amplifiers, as well as audio DSPs for consumer electronics applications. Its audio products are used in various consumer applications, including portable media players, smartphones, tablets, AVRs, DVD and Blu-ray disc players, home theater systems, set-top boxes, MP3 players, gaming devices, sound cards, and digital televisions; professional applications comprising digital mixing consoles, multitrack digital recorders, and effects processors; automotive applications consisting of amplifiers, satellite radio systems, telematics, and multi-speaker car-audio systems; and networked digital audio applications. The company also provides high-precision analog and mixed-signal ICs for energy control, energy measurement, and energy exploration applications; and ICs, board-level modules, and hybrids under the Apex Precision Power brand name for high-power pulse width modulation (PWM) and power amplifier applications; and proprietary products, which include ADCs, DACs, linear amplifiers, PWM amplifiers, and amplifier ICs; and system reference designs. Its energy products are used in digital utility meters, power supplies, lighting ballasts, motor control, energy exploration, and high-power systems. The company sells its products primarily to through direct sales force, external sales representatives, and distributors. Cirrus Logic, Inc. was founded in 1984 and is headquartered in Austin, Texas.
Advisors' Opinion: - [By Evan Niu, CFA]
Even as Apple (NASDAQ: AAPL ) continues to get relentlessly crushed today following Cirrus Logic's (NASDAQ: CRUS ) preliminary release last night, there may still be two silver linings for Apple investors. The data can't all be bad (it's mostly bad).
- [By Evan Niu, CFA]
Throughout this whole time, Cirrus Logic (NASDAQ: CRUS ) has been on my radar as the primary supplier of audio codec chips in iDevices, with Apple comprising 91% of sales in the December quarter. I've never invested in the company, primarily due to a feeling that I'd missed the boat already. Shares topped out over $45 late last year, making me think Cirrus would always be the one that got away.
Top Tech Stocks To Own Right Now: Analog Devices Inc (ADI.O)
Analog Devices, Inc. (Analog Devices), incorporated on January 18, 1965, is engaged in the design, manufacture and marketing of a range of analog, mixed-signal and digital signal processing integrated circuits (ICs). The Company produces a range of products, including data converters, amplifiers and linear products, radio frequency (RF) ICs, power management products, sensors based on micro-electro mechanical systems (MEMS) technology and other sensors, and processing products, including DSP and other processors, which are designed to meet the needs of a base of customers. The Company's products are embedded inside many different types of electronic equipment, including industrial process control systems; instrumentation and measurement systems; wireless infrastructure equipment, and aerospace and defense electronics. The Company designs , manufactures and markets a range of ICs, which incorporate analog, mixed-signal and digital signal processing technologies. The Comp any's product portfolio includes both general-purpose products used by a range of customers and applications, as well as application-specific products. On March 30, 2012, the Company acquired Multigig, Inc.
Analog Products
The Company's product portfolio includes several thousand analog ICs. The Company's analog IC customers include original equipment manufacturers (OEMs) and customers who build electronic subsystems for integration into larger systems. The Company is a supplier of data converter products. Data converters translate real-world analog signals into digital data and also translate digital data into analog signals. The Company is also a supplier of amplifiers. Amplifiers are used to condition analog signals. The Company provides precision, instrumentation, intermediate frequency/radio frequency (RF), broadband, and other amplifiers. The Company also offers a range of precision voltage references, which are used in a range of application s. The Company's analog product line also includes a range! p! ortfolio of RF ICs covering the RF signal chain, from RF function blocks, such as phase locked loops, frequency synthesizers, mixers, modulators, demodulators, and power detectors, to broadband and short-range single chip transceiver solutions.
The Company's RF ICs support the requirements of cellular infrastructure and a range of applications in the Company's target markets. Also within the Company's analog technology portfolio are products, which are based on MEMS technology. This technology enables the Company to build small sensors, which incorporate an electromechanical structure and the supporting analog circuitry for conditioning signals obtained from the sensing element. The Company's MEMS product portfolio includes accelerometers used to sense acceleration, gyroscopes used to sense rotation, inertial measurement units used to sense multiple degrees of freedom combining multiple sensing types along multiple axis, and MEMS microphones used to sense audio . The Company's current revenue from MEMS products is derived from the automotive end market. In addition to the Company's MEMS products, its other analog product category includes isolators. The Company's isolators have been designed for applications, such as universal serial bus isolation in patient monitors, where it allows hospitals and physicians to adopt the advances in computer technology to supervise patient health and wirelessly transmit medical records. In smart metering applications, the Company's isolators provide electrostatic discharge performance. In satellites, where any malfunction can be catastrophic, the Company's isolators help protect the power system while enabling designers to achieve small form factors. Power management & reference products make up the balance of the Company's analog sales. Those products, which include functions such as power conversion, driver monitoring, sequencing and energy management, are developed to complement analog signal ch ain components across core market segments from micro ! power,! e! nergy-s! ensitive battery applications to power systems in infrastructure and industrial applications.
Digital Signal Processing Products
Digital Signal Processing products (DSPs) complete the Company's product portfolio. DSPs are optimized for numeric calculations, which are essential for instantaneous, or real-time, processing of digital data generated, from analog to digital signal conversion. The Company's DSPs are designed to be fully programmable and to execute specialized software programs, or algorithms, associated with processing digitized real-time, real-world data. Programmable DSPs are designed to provide the flexibility to modify the device's function using software. The Company's DSP IC customers write their own algorithms using software development tools provided by the Company and third-party suppliers. The Company's DSPs are designed in families of products, which share common architectures and therefore can execute the same software across a range of products. The Company's customers use the Company's products to solve a range of signal processing challenges across its core market and segment focus areas within the industrial, automotive, consumer and communications end markets. As an integrated part of the Company's customers' signal chain, there are other Analog Devices products connected to its processors, including converters, audio and video codecs and power management solutions.
The Company competes with Broadcom Corporation, Maxim Integrated Products, Inc., Cirrus Logic, Inc., Microchip Technology, Inc., Freescale Semiconductor, Inc., NXP Semiconductors, Infineon Technologies, ST Microelectronics, Intersil Corporation, Silicon Laboratories, Inc., Knowles Electronics, Texas Instruments, Inc. and Linear Technology Corporation.
Top Tech Stocks To Own Right Now: Aviat Networks Inc.(AVNW)
Aviat Networks, Inc. engages in the design, manufacture, and sale of a range of wireless networking products, solutions, and services worldwide. It offers point-to-point and point-to-multipoint digital microwave transmission systems for first/last mile access, middle mile/backhaul, and long distance trunking applications. The company?s products include broadband wireless access base stations and customer premises equipment for fixed and mobile; point-to-point digital microwave radio systems for access, backhaul, trunking, and license-exempt applications; and supporting network deployments, network expansion, and capacity upgrades. It also provides network management software solutions to enable operators to deploy, monitor, and manage its systems, as well as third party equipment, such as antennas, routers, and multiplexers to build and deploy a wireless transmission network and a suite of turnkey support services. In addition, the company offers professional services, su ch as network planning and design, site surveys and builds, systems integration, installation, maintenance, network monitoring, training, and customer services. It serves mobile and fixed communications service providers, original equipment manufacturers, private network operators, government agencies, transportation and utility companies, system integrators, public safety agencies, and broadcast system operators, as well as pipeline, railroad, and other industrial enterprises that operate wireless networks. The company was formerly known as Harris Stratex Networks, Inc. and changed its name to Aviat Networks, Inc. in January 2010. Aviat Networks, Inc. is headquartered in Santa Clara, California.